Food Safety and Inspection Service

U.S. DEPARTMENT OF AGRICULTURE

Inspection Methods

Student Study Guide 

2 of 3

Only this provided printed Student Study Guide may be used during the test. 

Handwritten notes and highlights are allowed on the provided pages.

No additional pages, sticky notes, paper clips, or anything else added to the 

study guide is allowed.

Revised October 2023

Table of Contents

01 Course Information and Introduction ........................................................................... 7 

02 Statutes (Acts) ............................................................................................................11

03 Rules of Practice ........................................................................................................13

04 Regulatory Process Overview....................................................................................17

05 Food Safety Systems Fundamentals .........................................................................19

Professionalism...............................................................................................................22

06 Food Microbiology & Specified Risk Materials (SRM) ...............................................26

07 Sanitation Performance Standards (SPS)..................................................................36

08 Sanitation Standard Operating Procedures (SSOP)..................................................44

09 Sanitation Scenarios ............................................................................................Part 3 

10 Noncompliance...........................................................................................................54

11 HACCP Processing Categories and Fish Inspection.................................................58

12 HACCP 7 Principles....................................................................................................65

13 HACCP Regulatory Process.......................................................................................68

14 Hazard Analysis Verification (HAV) Task ...................................................................72

15 HACCP Verification Task............................................................................................77

16 Slaughter Food Safety Standard..............................................................................121

17 Salmonella and Campylobacter Testing ..................................................................125

18 Raw Beef Sampling ..................................................................................................133

19 Hazard Analysis Verification (HAV) and Raw Beef Sampling Scenario ..................142

20 Sampling Requirements to Demonstrate Slaughter Process Control ....................148

21 Humane Handling (Livestock) and Good Commercial Practices (Poultry).............153

22 Sanitary Dressing .....................................................................................................162

23 Review Establishment Data Task.............................................................................166

24 Ready-to-Eat and Shelf Stable Products Process Familiarization ..........................172

25 Lethality and Stabilization........................................................................................174

26 Food Ingredients of Public Health Concern.............................................................177

27 RTE-SS Hazards and Controls Workshop................................................................188

28 Ready-to-Eat Sanitation ...........................................................................................191

29 Listeria monocytogenes Regulations......................................................................195

30 RTE Sampling ...........................................................................................................207

31 HACCP System and Recall Verification...................................................................211

32 Export Certification ..................................................................................................222

33 Food Defense............................................................................................................226

34 Non-Food Safety Consumer Protection...................................................................230

PHIS Introduction to the Public Health Information System (PHIS).........................Part 3 

PHIS 1 – Establishment Profile .................................................................................Part 3 

PHIS 2 – Task List / Task Calendar ...........................................................................Part 3 

PHIS 3 – Inspection Documentation, NRs, MOI, Notes, Meeting Agenda ................Part 3 

PHIS 4 – Sample Management ..................................................................................Part 3 

PHIS 5 – Animal Disposition Reporting....................................................................Part 3 

Workshops.................................................................................................................Part 3 

PHIS Simulations.......................................................................................................Part 3 

Case Study Scenarios ...............................................................................................Part 3 

Food Safety Regulations Job Aid..................................................................................234

Acronyms.......................................................................................................................235

Note-taking Pages .........................................................................................................239

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16 Slaughter Food Safety Standard

Objectives:

1. List the three contaminants covered by the food safety standard in livestock slaughter.

2. Identify the carcass parts that must be free of the three contaminants covered by the 

livestock food safety standards.

3. Identify the location where FSIS verifies the food safety standard for livestock carcasses.

4. Identify the contaminants covered by the food safety standard in poultry standard.

5. Identify the location where FSIS verifies the food safety standards for poultry carcasses.

6. Describe how to perform the livestock zero tolerance verification task.

7. Describe how to perform the poultry zero tolerance verification task.

8. List the actions IPP take when they find a zero tolerance failure during the performance of 

the poultry and livestock zero tolerance verification tasks.

9. Describe the enforcement actions when repetitive zero tolerance noncompliance is 

documented in PHIS.

The Food Safety and Inspection Service (FSIS) published in FR 97-067N notification that the Agency 

views its ‘‘zero tolerance” for visible fecal material as a food safety standard. In slaughter 

establishments, fecal contamination of carcasses is the primary avenue for contamination by 

pathogens, including Shiga toxin-producing E. coli (STECs), Salmonella, and Campylobacter.

Pathogens may reside in fecal material, both in the gastrointestinal tract and on the exterior surfaces 

of the animal or bird going to slaughter. Without proper handling and sanitary dressing procedures 

during slaughter, the edible portions of the carcass can become contaminated with bacteria capable 

of causing illness in humans. The organisms may spread directly from carcass to carcass or 

indirectly by hands, utensils, or equipment.

Enforcing Food Safety Standard for Livestock Postmortem

References: FSIS Directive 6420.2, Regulations 9 CFR 310.17(a), 9 CFR 310.18(a), and Part of 9 

CFR 417.

The contaminants that are covered by the food safety standard in livestock slaughter are feces, 

ingesta, milk. Carcasses, and head meat, cheek meat and weasand meat must be free of these 

contaminants.

On-line IPP verify the removal of contamination while examining heads, viscera, carcasses, and 

carcass parts during post-mortem inspection. If on-line IPP observe contamination on heads, viscera, 

carcasses and carcasses parts, IPP do not pass the carcass or part until all of the contamination is 

promptly removed in a satisfactory manner. When contamination is present the line is stopped unless 

the establishment provides a rail-out loop and the IIC has no concerns about the rail-out procedures. 

On-line IPP will notify the IIC when they suspect the establishments slaughter or sanitary dressing 

procedures are not under control or rail-out procedures are inadequate. IPP verify that livestock 

slaughter establishments are complying with 9 CFR 310.17(a), and 9 CFR 310.18(a).
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Off-line IPP are to perform the Livestock Zero Tolerance Verification task on carcasses and head, 

cheek, and weasand meat at a minimum of one time per slaughter shift.

When performing the Livestock Zero Tolerance Verification Task, inspection program personnel (IPP) 

are to determine the number of carcasses or carcass sides to be examined based on the expected 

slaughter volume for that shift (number of animals). For head, cheek, and weasand meat, IPP are to 

examine no less than the amount of product the establishment has listed in its HACCP plan for the 

monitoring procedure.

FSIS verify the food safety standards for livestock carcasses at or after the postmortem rail 

inspection station andbefore the final wash, or any additional trimming, washing, or application of 

any interventions.

FSIS verify the food safety standard for head meat, cheek meat, and weasand meat in livestock 

slaughter operations at the completion of the harvesting process, after all of the establishment 

controls and interventions. This verification may occur at the time of packaging or when the product 

is placed in a container for storage.

For livestock (except swine) the HACCP plan must include, as appropriate, critical control points 

(CCPs) that are designed to control identified food safety hazards (9 CFR 417.2(c)(2)). This is 

because fecal material is a vehicle for pathogens, and because virtually all slaughter establishments 

recognize that contamination of meat by pathogenic microorganisms from fecal material, ingesta, or 

milk is a food safety hazard that is reasonably likely to occur in the slaughter production process.

Note: 9 CFR 310.18(c) requires swine slaughter establishments to develop, implement, and maintain 

written procedures to prevent contamination of carcasses and parts by enteric pathogens, and visible 

fecal material, ingesta, and milk contamination throughout the entire slaughter and dressing operation. 

Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, 

or other prerequisite programs.

Enforcing the Food Safety Standard for Poultry Postmortem

References: FSIS Directives 6420.5 and 6500.1, FSIS Regulation 9 CFR 381.65(f), and part 417.

The contaminant that is covered by the food safety standard in poultry slaughter is feces.

At poultry slaughter, the fecal contamination checks are performed at either pre-chill testing station 

or any location after final trimming prior to the chiller tank in establishments operating under 

traditional inspection.

Off-line IPP are to conduct the Poultry Zero Tolerance task at least two fecal contamination checks for 

each evisceration line for every shift. The verification method involves randomly selecting ten 

carcasses and examining following the FSIS Directive 6420.5.

Note: Poultry major portions and parts are not subject to poultry zero tolerance verification but are

subject to slaughter HACCP or SSOP verification.
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Documenting Compliance with the Zero Tolerance Task

When IPP do not observe any fecal material, ingesta, or milk on livestock carcasses or on 

head, cheek, or weasand meat, or feces on poultry carcasses during the verification, they select 

the mandatory regulation on the “Regulations” tab. IPP mark the zero-tolerance task as 

‘Inspection Completed’ at the bottom of the Inspection Results page.

Documenting Noncompliance with the Zero Tolerance Task

If IPP find feces, ingesta, or milk on livestock carcasses or head meat, cheek meat, or 

weasand meat while performing the livestock zero tolerance verification task, or find feces on 

poultry carcasses while performing the poultry zero tolerance verification task, IPP are to:

• Verify regulatory requirements associated with 9 CFR 310.18(a) (livestock) or 

9 CFR 381.65(f) (poultry);

• Notify the establishment that a zero tolerance noncompliance with 9 CFR 

310.18(a) or 9 CFR 381.65(f) exists;

• Document the noncompliance on an NR citing 9 CFR 310.18(a) or 9 CFR 381.65(f);

• For poultry zero tolerance failures include a statement that the 

establishment is not preventing feces from entering the chiller.

Additional Verification after Positive Zero Tolerance Findings (Livestock except Swine)

• When IPP determine zero tolerance noncompliance while performing the Zero 

Tolerance Verification task they are to perform a Slaughter HACCP Verification 

task to verify that the establishment performs corrective actions for the affected 

product in accordance with 9 CFR 417.3(a).
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Additional Verification after Positive Zero Tolerance Findings (Poultry or Swine)

After notifying the establishment of the zero-tolerance noncompliance, off-line IPP are to:

• Schedule either a directed Slaughter HACCP or Operational SSOP Review and 

Observation verification task in PHIS;

• Indicate “zerotolerance noncompliance” as the reason for performing the directed task in 

PHIS; and

• Verify the establishment has performed all the required corrective actions in accordance with 9 

CFR 417.3(a) if the controls are in the HACCP plan, 9 CFR 417.5(a)(1) if the controls are in the 

prerequisite programs, or 9 CFR 416.15(b) if the controls are in the SSOP’s and is properly 

implementing its HACCP system.

Note: If IPP find zero tolerance failures on livestock carcasses past the final rail or on poultry 

carcasses, major portions, or parts at or beyond the pre-chill testing station while performing 

inspection tasks other than the zero tolerance task (“stumble-on” occurrences), they are to 

document the noncompliance under the appropriate PHIS task (Slaughter HACCP or Operational 

SSOP Review and Observation verification task).

The System Approach in Enforcement

If IPP find repeated zero tolerance noncompliances and determine that these findings are 

from the same cause orindicate a systemic issue, the current NR is to be associated with the 

most recent zero tolerance or related NR. When associating NRs for the same cause, IPP are to 

follow the methodology set out in FSIS Directive 5000.1.

If the findings do not show the same cause, IPP are NOT to associate the NRs.
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17 Salmonella & Campylobacter Testing

Objectives:

1. Understand why Salmonella and Campylobacter is a huge concern for FSIS and Industry 

in poultry slaughter and processing establishments.

2. List the types of products that are eligible for testing.

3. Recognize the sampling codes for the eligible products.

4. Know the frequency at which samples should be taken.

5. Explain how FSIS uses the moving window approach when assessing process control.

6. Explain how to obtain completed results using LIMS-Direct and PHIS

7. Understand the three process control categories.

8. Know what actions to take when an establishment is in Category 2 or 3.

9. Explain when and how to document a MOI regarding categorization.

10. Be able to verify ineligible raw product destined for ready-to-eat at an official 

establishment.

Performance Standards

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.

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.

Salmonella bacteria are the most frequently reported cause of foodborne illness.

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 foodborne illness, and C. 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. 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.
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SALMONELLA AND CAMPYLOBACTER VERIFICATION – FSIS Directive 10,250.1

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.

ASEPTIC SAMPLING

FSIS inspectors collect verification samples using aseptic techniques. Aseptic techniques help 

prevent contamination of the sample and help protect the integrity of subsequent test results.

Follow these steps:

1. Choose a staging area for gathering and preparing your sampling supplies. Use a wheeled, 

stainless-steel cart and a small tote or caddy to transport your supplies and the sample to 

and from the sample collection location.

2. Prepare the supplies you need for the specific sampling project. For example, for sampling 

turkey carcasses, you would mix the sample solution with sponges prior to collecting the 

sample.

3. Label your sample containers before collecting the sample.

4. Wear a clean lab coat and hair net to avoid contamination. Follow your plant’s garment 

requirements when you collect the samples.

5. Wash your hands and forearms and dry them with a paper towel. (If there is no sink at the 

sample collection location, wash your hands and forearms when you first enter the 

processing floor and head directly to the sampling location. Another option is to use a 

waterless hand sanitizer.)

6. After cleaning your hands and forearms, clean and sanitize your work surfaces. Use the 

same sanitizing solution the establishment uses, according to label directions. Allow the 

surface to air dry completely prior to placing any sampling utensils on it.

7. Ensure that your sample collection equipment is clean, sanitized, or sterile, as applicable to 

the sampling project. Clean totes frequently that are used to store and transport supplies.

8. Put on the gloves included in your sampling supplies. (See Gloving Technique below.) If the 

gloves tear or become contaminated at any time, discard them and put on a new pair. Once 

you put on the gloves, touch nothing other than the sample equipment and sample.

9. Follow the sample collection protocol. Collect all samples in sterile containers that came 

with the sample supplies. Ensure that no items, surfaces, or clothing touch the sample or 

sampling site.

10. When you collect liquid samples in a jar with a lid, hold the lid in one hand while collecting 

the sample. If any product spills on the outside of the jar, cap the jar and wipe it clean with a 

dry paper towel. Do not use any sanitizer solution to clean the jar.
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GLOVING TECHNIQUE

1. Wash and sanitize your hands up to the mid-forearm. Dry your hands using disposable 

paper towels. If a sink is not available at the sample collection location, use a waterless 

sanitizer. Wash your hands prior to sanitizing the work surface as well.

2. The gloves will arrive in secondary packaging. After you sanitize your work surface, open 

the glove package on the sanitized surface.

3. Pinch the cuff end with two fingers to pull the gloves from the outer packaging, protecting 

the outer surface from contact with any un-sanitized surfaces.

4. Hold the glove open at the inside cuff area. Insert your hand into the glove, palm side up. 

Put on the first glove: grasp and pull the cuff with your ungloved hand. If your fingers 

become stuck, gently wiggle them while gently pulling the cuff. To protect from 

contamination, do not touch your gloved hand to any un-sanitized surface. If the glove tears 

or becomes contaminated, discard it and put on a new pair. (If you need more gloves, send 

a request to the laboratory on the sampling form or in the instructions specific to the 

sampling project.)

5. Put on the second glove: use your gloved hand to slide your fingers under the cuff. 

Grasping the cuff with your gloved hand, insert the fingers of your non-gloved hand into the 

glove and pull the glove on.

6. Once you have donned both gloves, you may touch the outside of a glove with the other 

gloved hand to adjust the fit. To avoid contamination, be careful not to touch any unsanitized surfaces with your gloved hands.

7. If at any time you think a glove may have become contaminated, discard it and repeat the 

donning procedure with a new pair.

POULTRY CARCASSES:

(1) Young chicken carcasses including broilers, fryers, roasters, and Cornish game hens, as 

described in 9 CFR 381.170(a) (HC_CH_CARC01), and

(2) Young turkey carcasses (HC_TU_CAR)

Collecting the Sample

How To Collect the Sample:

1. IPP are to randomly select a carcass from the post-chill area after all interventions have taken 

place.

2. IPP are to allow excess fluid to drain (for at least 1 minute) without contaminating any sterile 

sample items.

3. Place the carcass in the bag (neck first) and place the bag with the carcass on the flat sanitized

surface.

4. Gently invert the sampling broth container three (3) times immediately prior to pouring the broth into the 

cavity of the carcass inside to the bag.
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5. Once the broth has been added to the carcass, remove the excess air from the bag, close it and 

mix the broth through the carcass cavity and outside of the carcass for one minute.

6. Place the bag with the chicken on the sanitized flat surface with the top of the bag facing up.

7. Carefully open the plastic bag containing the bird without touching the inside of the bag or the inside 

corners.

8. Work the plastic bag down around the carcass and firmly grip one leg, without touching the inside of 

the plastic bag.

9. While holding the bag with one hand, carefully remove the bird from the bag with the other hand 

and place the bird back on the conveyor or table.

10. Remove the screw-cap from the sterile sample container and aseptically pour 100 ml of rinsate into 

the sample container.

11. Close the sample container while trying not to touch the inside of the lid so that it does not 

contaminate the sampling broth. (Ensure that the lid is correctly threaded and tightened, but do not 

over-tighten.)

12. Place the sample container in the small resealable bag, expel excess air, and seal the bag.

13. Discard all remaining liquid from the carcass rinse bag into a drain (do not share remaining rinsate 

with establishment personnel).

14. Refrigerate the sample promptly after collection. IPP are to hold the rinsate in a refrigerator set 

at 40° F or lower and under FSIS control until the samples are shipped. IPP are not to freeze 

samples.

RAW CHICKEN PARTS (HC_CPT_LBW01):

Products eligible for sample collection under the chicken parts sampling project include raw chicken legs, 

breasts, and wings that would typically be available for consumer purchase. These products can be skinon or skinless and can be bone-in or boneless. Eligible parts can be mechanically tenderized, vacuum 

tumbled, or injected or otherwise marinated or coated in solutions or dry spice mixtures, but cannot be 

breaded, stuffed, or wrapped in dough.

Cut-up chicken parts are eligible for sampling provided they are equal to or larger than 3/4 inch in size in 

at least one dimension and are of a type that would typically be available for consumer purchase.

1. For legs, whole legs (no backbone attached), drumsticks, thighs, thighs with backbone attached, and 

cut up or portioned leg meat (3/4 inch or larger in at least one dimension) are eligible for sampling;

2. For breasts, whole and half breasts (with or without ribs), boneless and skinless chicken breasts, 

tenderloins and tenders, and cut up or portioned breast meat (3/4 inch or larger in at least one 

dimension) are eligible for sampling; and

3. For wings, whole wings (with or without the wing tip), mixed wing sections, drummettes, midsections 

(flats), wing tips, and boneless wings are eligible for sampling.
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How to Collect the Sample:

IPP are to collect a rinsate from 4 lbs ± 10% (3 pounds, 10 ounces to 4 pounds, 6 ounces) of the 

specified raw chicken parts. Finished chicken parts are to be sampled prior to freezing.

1. Randomly select which available eligible chicken parts (legs, breasts, and wings) to sample.

2. Collect and place into the sampling bag approximately 4 lbs ± 10% (3 pounds, 10 ounces to 4 

pounds, 6 ounces) of randomly selected product. (Avoid transferring excess processing liquid when 

placing the chicken parts in the sampling bag).

3. Place the bag with the parts on the flat sanitized surface.

4. Gently invert the sampling broth container three (3) times immediately prior to adding the sampling 

broth to the chicken parts.

5. Open the container and pour the sampling broth onto the parts inside the bag.

6. Once the broth has been added to the bag, remove the excess air from the bag, close it and mix the 

broth throughout the parts for one minute.

7. Place the bag with the chicken parts on the sanitized flat surface with the top of the bag facing up;

8. Carefully open the plastic bag containing the parts without touching the inside of the bag or the inside 

corners.

9. Pour approximately 120 ml of the sampling broth into the specimen jar. Donot allow the bag to 

touch the sterile specimen jar.

10. Close the sample container while trying not to touch the inside of the lid so that it does not 

contaminate the sampling broth. (Ensure that the lid is correctly threaded and tightened, but do not 

over-tighten.)

11. Discard any remaining rinse fluid into a drain and return the parts to where you initially collected them 

unless the establishment requests otherwise.

12. Refrigerate the sample promptly after collection. IPP are to hold the rinsate in a refrigerator set 

at 40°F or lower and under FSIS control until the samples are shipped. IPP are not to freeze 

samples.

NRTE GROUND AND OTHER COMMINUTED POULTRY SAMPLING PROGRAM (HC_CH_COM01):

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:

• 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

• Mechanically Separated (Mechanically Separated product group) – mechanically 

separated chicken or turkey, as defined in 9 CFR 381.173; or

• 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 non-battered comminuted products).
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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).

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).

The following products are not eligible for sampling under this project:

1. Injected, needle- or blade-tenderized, or vacuum tumbled raw poultry parts or carcasses, 

because they are not considered to be NRTE comminuted poultry;

2. Mixed-species NRTE comminuted poultry products (for example, raw sausage containing 

both raw ground turkey and raw ground pork or containing both raw ground chicken and 

raw ground turkey);

3. Diced, chunked, or sectioned poultry that is not in small pieces or that is otherwise not 

comminuted. In general, this would refer to pieces 3/4 inch or greater in any dimension;

4. Hand- or mechanically-deboned products that are not further chopped, flaked, minced, or 

otherwise processed to reduce particle size;

5. Whole muscle parts because they are not comminuted;

6. Poultry trimmings because they are not comminuted;

7. Comminuted poultry that is portioned (product from a larger package broken down into 

smaller packages but not cut-up or otherwise processed) only or repackaged only;

8. Any NRTE finished product containing comminuted poultry that has been cooked or heattreated (for example, in the HACCP processing category “Heat-treated but not Fully 

Cooked – Not Shelf Stable”); and

9. Dumplings, wontons, potstickers, eggrolls, pelmeni, or other comminuted chicken or turkey 

products wrapped in dough or other similar covering (nor their source material when these 

are the final products in the establishment).

When an establishment processes all its products into ready-to-eat (RTE) product or 

diverts allof its raw products (including NRTEcomminuted poultry) to anotherfederally 

inspected establishment for further processing into an RTE product, FSIS will exclude 

the establishment from the Salmonella verification-testing program schedule.

If an establishment states that the intended use of its ground or comminuted 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. IPP should verify:

1. HACCP records matched with Bills of Lading

2. Letters of Guarantee

3. Contractual agreements between the producing establishment and receiving 

establishment

It is not sufficient for the IPP to accept only labels that state "for further processing."

It is not sufficient if the establishment only maintains a letter from the receiving establishment 

that says it only produces RTE product, without the receiving establishment gathering
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additional information to verify that all product is processed into RTE product in an official 

establishment.

* Note: If an establishment does not have procedures incorporated into its food safety 

movement of all product to another federally-inspected establishment, at which the product is 

further processed into RTE products, the establishment is subject to sampling under the 

Salmonella and Campylobacter Verification Testing program.

How to Collect the Sample:

1. IPP are to randomly collect eligible raw comminuted poultry samples by product group.

2. IPP are to collect finished product in its final package whenever possible.

a. IPP are to collect the appropriate number of packages so that the sample equals 

two pounds or may collect a slack-filled package for larger products. IPP are to 

place the product collected in its final packaging in the larger, nonsterile bag 

provided with the sampling supplies

3. For finished product not available in final packaging or when the package is too large, IPP 

are to collect the sample aseptically, as close to packaging as possible, after all 

antimicrobial interventions have been applied.

a. Collect sufficient product to fill the two provided Whirl-Pak® bags up to the fill-line 

indicated on each bag. When the bag is closed, product should meet the line 

indicated on the Whirl-Pak® bag.

b. Ensure that each Whirl-Pak® bag is properly closed. To do this, IPP are to 

carefully squeeze out the air remaining in the bag and tightly fold over the top at 

least four times as trapped air and loose closures may lead to leakage. When 

folding over the tops of each bag, IPP are to ensure that they do not touch the bag 

near its opening. Next, IPP are to fold over the side tabs to secure the folds in 

place and to not tie the ends. This process is to be repeated for the second bag.

c. IPP are to place both Whirl-Pak® bags in the same secondary containment bag 

(zipper-lock type bag), expel excess air from the bag, and close the containment 

bag using the zipper lock closure.

PERFORMANCE STANDARDS – FSIS DIRECTIVE 10,250.2

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.

Salmonella and Campylobacter performance standard verification samples are taken as part of 

a 52-week moving window and the results are used to determine if an establishment is 

meeting the performance standard on a continuous basis.

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).
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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.

Performance Categorization

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.

IPP Responsibilities

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.

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. 

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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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)

FSIS Directive 10,250.1 describes the sampling steps appropriate to the product class sampled. 

For NRTE comminuted poultry products and raw chicken parts, IPP are to follow instructions as 

stated in the “IPP Help” menu under FSIS Applications. Following is a brief narrative for the 

procedures described in FSIS Directive 10,250.1 that the IPP will be carrying out when 

collecting the samples.

IPP can review the status and results of the sampling through LIMS (Laboratory Information 

Management System) Direct. You can access the link for LIMS under the FSIS Applications 

short cut on your FSIS government computer.

Documenting the MOI

IPP are to ensure that the MOI documenting the weekly discussion with the establishment 

management follows the content and formatting guidance in Chapter IV of FSIS Directive 

8010.2 Investigative Methodology.

1. It is written in the first-person point-of-view of the FSIS employee preparing the MOI.

2. Documents the date and location of the meeting.

3. Documents the name and official position of the FSIS employee conducting the meeting 

and of any other FSIS employee present.

4. Documents the name and official position of all establishment employees attending the 

meeting.

5. Summarize all information discussed during the meeting.

6. Includes a closing statement certifying that the MOI includes all the information discussed 

during the meeting.

7. Is promptly signed and dated by the preparer upon completion.
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18 Raw Beef Sampling

Objectives:

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.

In raw beef, the pathogen of concern is Shiga toxin-producing Escherichia coli (STEC). The 

most well-known STEC is Escherichia coli (E. coli) O157:H7 is a foodborne pathogen, but it 

is not the only one; other STEC serogroups are pathogenic as well. STEC is a food safety 

hazard that establishments need to consider in their hazard analysis if they are 

slaughtering, receiving, grinding, or otherwise processing raw beef products. Establishments 

may list E. coli O157:H7, all 7 STEC adulterants, or STEC in their hazard analysis. FSIS 

considers all raw non-intact beef and raw intact beef intended for use in raw non-intact 

product that is contaminated with the following STEC serogroups to be adulterated under the 

Federal Meat Inspection Act (21 U.S.C. 601(m)(1)): E. coli (O157, O26, O45, O103, O111, 

O121, and O145).

FSISverification sampling programs are designed to verify that an establishment’s controls or 

food safety procedures adequately address STEC.

Definitions

Alternative - Alternative sampling and alternative lotting. 

Recall - An establishment’s voluntary removal of distributed meat or poultry products from 

commerce.

Sample - Represent a larger amount of product. Samples of raw products may be destructive, collecting 

actual product to send to the lab, or non-destructive, swabbing the products with a cloth to sendto the lab.

Sampledlot - Amount of product represented by the sample.
135

The establishment determines their lotting procedures. Establishments must support how 

they identify adulterated product when they experience a positive sample result.

Samples are selected randomly from the type of product requested. Select day, shift, and 

time within the collection dates indicated in PHIS establishment Task List. Sample during all 

shifts that the establishment operates. Samples are collected after all antimicrobial 

interventions are applied to the production lot to be sampled, except for any microbiological 

testing intervention. Take samples prior to freezing, except when the freezing step is a CCP in 

the HACCP plan. Collect in their final packaged form, using aseptic technique. If the product is 

not in its final package, you must put the grab samples in the sterile roll top bags.

The PHIS task name will identify the sampling project code. Determine eligible products, 

focusing on the establishment's process(es), and allow adequate time for the 

establishment to hold the sampled lot, but not enough time for them to alter their 

normal processes—less than 1 day’s notice (if it does not cause undue hardship to the plant), 

1 day’s notice is sufficient, but possibly 2 days’ notice if necessary. If more than 2 days’ notice 

is requested, contact your supervisor. IPP collect supplier information for each sample taken, 

at the time the sample is taken. The goal of traceback is two-fold: (1) to ensure all affected 

product is quickly accounted for and (2) to trace it back to the originating slaughter plant. The 

District Office (DO) will use the supplier information to identify the originating slaughter facility, 

if the sample result is confirmed positive. Information that needs to be collected for source 

materials from other establishments includes name of the beef components or information 

that clearly identifies the source material. Document the source material and foreign supplier 

information in a memorandum of interview (MOI) in PHIS and maintain the MOI in the official 

file. Provide a copy to establishment management. You also make a note of any information 

that the establishment is unable to provide in the MOI.

An accurate Establishment Profile is critical – FSIS uses the information in the PHIS 

establishment profile to generate specific sampling tasks.

The key policy related to raw beef sampling can be found in FSIS Directive 10,010.1, Sampling 

Verification Activities for Shiga Toxin-Producing Escherichia coli in Raw Beef Products. This 

directive has been revised with instructions for collecting and submitting samples of raw beef 

products. Below is an abbreviated version of sampling directions.
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Sampling Project Codes

The routine sampling project codes for STEC testing of domestic raw beef at federal establishments are:

• MT60_C –Raw Beef Manufacturing Trimmings from cattle slaughtered onsite

• MT64 –Components other than Trim

• MT65_C –Bench Trim, derived from cattle not slaughtered onsite

• MT43 – Routine Testing of Raw Ground Beef in Federal establishments

The raw beef products collected under routine verification testing will be analyzed for E. coli

O157:H7, non-O157 STEC, and Salmonella.

Selecting and collecting MT60_C / MT65_C samples

Raw beef manufacturing trimmings and bench trim samples are to be collected using the Cloth 

Sample Collection Method (fresh product) or the N60 excision method (frozen product) only when 

the establishment uses freezing as an intervention in their HACCP system.

A. Cloth Sample Collection Method

1. The Cloth sampling technique is used for routine verification sampling of eligible domestic 

raw beef products. With the cloth sampling method, 1 cloth is a sample unit. Do not use 

the cloth to sample frozen beef products. If the establishment uses freezing as an 

intervention in their HACCP system, request sample supplies for N60 excision sampling of 

the frozen trim.

2. If the establishment packages product in combo bins, then IPP are to select one random 

combo bin from the specific production (e.g., day’s production) available for sampling. Use 

1 cloth to sample the entire surface of the combo bin. If the establishment packages 

product in boxes, totes, tubs, or containers other than combo bins, IPP are to use 1 cloth to 

sample up to 5 containers from the same lot of product. A total of 1 cloth is collected and 

shipped to the lab.

3. IPP are to wash and dry hands to the mid-forearm. Put on plastic long-sleeved gloves, 

followed by non-sterile short gloves over the top. Using an alcohol-based spray sanitizer 

(available from the FSIS Material Management Supply Center), IPP are to sanitize gloved 

hands and plastic sleeves simultaneously.
137

4. IPP are to grasp the cloth with both hands and apply downward pressure to vigorously 

massage the surface area of the product including the spaces and crevices between 

meat pieces, to ensure as much of the product surface area is sampled, while moving 

around the combo in a uniform manner.

5. After sampling, the cloth will be damp and have picked up moisture and bits of meat

scraps when the collection is completed.

6. Fold the cloth and return it to the plastic sample bag. Add the entire contents of the liquid 

buffer to the bag. Carefully expel excess air from the sample bag, tightly fold over the top at 

least four times, and then fold over the side tabs to secure the folds in place.

B. N60ExcisionMethod

1. Sanitize the knife, steel, and hook. Wash and dry hands, open the sterile Whirl-Pak® bags 

and then put on the sterile gloves (don’t forget to wear a mesh glove under the sterile glove).

2. 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.

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

3. Aseptically collect the appropriate number of pieces of beef trim from one production lot. 

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). It is important to collect thin slices because 

the surface of the beef carcass can be contaminated through improper sanitary dressing 

procedures. Also, make sure that each sample slice contains some meat and only collect one 

slice from each piece of trim.
138

4. Place each slice in one of the sterile Whirl-Pak® bags. Continue this process until you have 

collected 30 pieces in one Whirl-Pak® bag. Next, repeat the same steps with the second 

Whirl-Pak® bag.

5. In the third sterile Whirl-Pak® bag, aseptically collect samples of trimmings from the same 

production lot by using a grab sample technique. Again, collect pieces with as much external 

surface as possible. 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.

6. Once sample collection is complete, carefully expel excess air from the sample bag, tightly 

fold over the top at least four times and then fold over the side tabs to secure the folds in 

place.

NOTE: Do not use the N60 method when collecting MT60_C beef manufacturing trim or 

MT65_C bench trim unless the establishment implements freezing as an intervention to 

reduce STEC. If freezing is used as an intervention, then the sample is to be collected by the 

N60 excision method.

Collecting Raw Ground Beef Products in final packaging (MT43)

1. 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.

2. Collect the number of packaged products so that the sample equals 2 lbs. This may be more 

than one package if the product is packaged in containers that weigh less than 2 lbs.

Collecting a Raw Ground Beef AsepticGrab Sample (MT43 and MT64)

NOTE: Use this method to collect raw ground beef product samples if it is not available in its final 

packaging or the package is too large.

1. Wash and dry your hands.

2. Open the sterile roll top bags and put on sterile gloves.

3. Aseptically (avoiding contamination) collect grab samples of raw ground beef.

4. Collect a sufficient quantity of raw ground beef to fill each of the three Whirl-Pak® bags to the fill-
139

line. Do not under-fill or overfill the bag. This should give you the 2 lbs.

5. Once sample collection is complete, carefully expel excess air from each Whirl-Pak® sample 

bag, tightly fold over the top at least four times and then fold over the side tabs to secure the 

folds in place.

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. Be sure the identification on the sample and the paperwork match, otherwise the lab will 

discard sample. 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.

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.

Every FSIS verification sample that the laboratory confirms positive for STEC goes through 

three stages of analysis: Potential Positive, Presumptive Positive, and Confirmed STEC 

Positive. Any presumptive or confirmed positive product must be maintained under 

establishment control. Consider the possibility that the establishment may have moved the 

product off-site but did not transfer ownership of the product, and therefore the establishment did 

not yet complete the pre-shipment review. When an FSIS verification sample is confirmed STEC 

positive, IPP are to issue and NR, unless the establishment also tested the same lot of 

product and found it positive for STEC. If the establishment has a written program to divert all 

product that FSIS samples to cooking, the establishment must take corrective action per 9 CFR

417.3. If the establishment does not take corrective action, then issue an NR. Use a directed 

HACCP Verification task for the appropriate HACCP category, raw ground, or raw not-ground. 

Cite 9 CFR 417.4(a) (Verification regulation – because sampling is considered a verification of the
140

overall effectiveness of the system) and 301.2. When writing NRs, associate where appropriate.

IPP are to review the establishment’s Sanitation SOPs for the days of production associated 

with the positive STEC sample to see if there was a problem with the implementation of their 

sanitation programs. IPPare to use the “risk based” approach. Verify sanitary dressing procedures, if 

the positive result is from beef manufacturing trimmings or other components produced at a slaughter 

establishment.

Raw beef products confirmed positive for STEC 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. As 

part of the follow up HACCP Verification task, verify that the establishment maintained records 

identifying the official establishment, renderer, or landfill operation that received positive product. 

When the product is destined for a landfill or rendering operation, it moves under company 

controls. When the product is shipped to another official establishment, establishments may 

use their own company seals or move the product under USDA seals or FSIS Form 7350-1.

Documentation 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. The establishment cannot complete the pre-shipment review until it receives 

documentation from the official establishment showing proper disposal.

If you are the IPP at the establishment that receives components positive for STEC, you have 

verification to perform. Verify the HACCP plan includes adequate lethality treatment to 

destroy the pathogen, and that the establishment has supporting documentation validating the 

effectiveness of the lethality treatment. When raw beef products are confirmed positive, FSIS 

will conduct verification activities at supplier establishments, particularly the originating 

supplying slaughter establishment that produced the source materials, trimmings, 

components, or primal cuts that were used to produce the positive product. The DO will contact 

the IIC at each of the supplying establishments, including the originating supplying slaughter 

establishments. 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.
141

Each time that an FSIS, or other Federal or State sample of raw beef product tests positive for 

STEC, 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 STEC or when an originating slaughter 

establishment is the sole supplier or a repeat supplier of the source materials implicated in 

positive sample result. For low volume establishments, 8 follow-up samples need to be 

collected. DO NOT wait for the establishment to complete the corrective actions. Collect follow-up 

samples from the same type of product that tested positive. If the establishment is not producing 

the product that tested positive, collect follow-up samples from Beef Manufacturing Trimmings or 

other components. Collect a maximum of 2 follow-up samples per shift per day from different lots 

(up to 4 samples per day for a 2-shift establishment). At a minimum collect 3 samples per week. 

Do not collect a follow-up sample and a routine verification sample from the same product lot.

FSIS continues to collect samples after a positive follow-up sample result until the FSIS 

laboratory finds no positive sample results. PHIS automatically assigns the requested follow-up 

sampling tasks. If an originating slaughter establishment was the only supplier = 16 follow-up 

samples, if multiple originating slaughter establishments supplied source materials for the 

positive product or they are a repeat supplier = 16 follow-up samples, when a supplier is not 

the sole supplier or a repeat supplier, a single follow-up sample is collected from the supplier 

for each source material used in the positive raw beef product.

There is no regulatory requirement for establishments to have their own STEC sampling 

and testing program. Many establishments do sample raw beef products for a variety of 

reasons. You are to review the results of the establishment’s testing programs related to its 

food safety systems on a weekly basis and document it on Review of Establishment Data 

task. The establishment does not have to tell you when it gets a positive result, but it 

must always implement corrective actions, and IPP should verify them. If the 

establishment uses cooking to eliminate STEC as a food safety concern, the establishment’s 

HACCP plan must address the presence of STEC. CCP and critical limits must be designed 

to eliminate STEC.
142

19 Hazard Analysis Verification (HAV) and Raw Beef Sampling Scenario

Objective: To review performance of certain steps of the HAV task.

Scenario: You recently submitted a sample of raw ground beef which was confirmed positive 

result for E. coli O157:H7. You decide to perform a directed HAV task as one follow-up. Excerpt 

of establishment documents provided.

Consider:

• What documents and records should you review?

• What will you look for when reviewing these documents and records?

• What findings would be evidence of noncompliance?

Product Description

Common Name: GroundBeef Patties

Formulation: Fresh beef trimmings from Open 

Beef

Packaging: Bulk (frozen patties) in 20 lb box

Shelf Life: 3-6 months if frozen

Intended Use Restaurants

For Training Purposes Only
143

Process Flow Diagram

ReceivePackaging 

Materials

ReceiveBeef 

Trimmings

Store Beef Trimmings

StorePackaging 

Materials

WeighBeef 

Trimmings

Coarse Grind

Blending/Mixing

Final Grind

Packagingand 

Labeling Patty Forming

Freezing

Frozen Patty Storage

Shipping Distribution
144

Raw Non-Intact Product Hazard Analysis (Ground Beef Patties) ...EXCERPT...

Process 

Step

FoodSafety 

Hazard

Reasonably 

Likely to 

Occur

Basis Measures Applied to Prevent, Eliminate, or 

Reduce the Hazard to an Acceptable Level

ReceivingRaw Beef 

Trimmings

Biological: 

Pathogens:

No E. coli O157:H7 is a 

known pathogen in 

raw beef products

Receiving Inspection Program

E. coli

O157:H7

Salmonella

(Interventions for E. 

coli should also 

reduceSalmonella)

BSE/ SRMs No SRMs may be found 

in incoming product 

from beef animals

Supplier will provide documentation that 

product is derived from animals less than 30 

months of age and the SRMs are removed

Chemical: 

None

Physical: 

Foreign 

Materials

No Damagedcontainers 

canresult in product 

exposure to foreign 

material or cross 

contamination.

Visual inspection for damaged containers at 

receiving – (Receiving log)

... ... ... ... ...
145

RECEIVING INSPECTION PROGRAM

Required Documents

Before unloading beef trimmings from truck trailer, the receiving manager will verify there is 

documentation accompanying the shipment stating that:

1. Intervention(s) were applied to the source materials of the beef trimmings in compliance with 

the supplier’s HACCP program.

2. The beef trimmings are derived from cattle that are less than 30 months of age and SRMs 

have been removed.

3. Each lot of beef trimmings has been tested and found to be negative for E. coli O157:H7, 

each lot has an associated letter of guaranty.

Measuring Receiving Temperature

The surface temperature of the beef trimmings must be ≤ 40oF. Temperature is monitored in at 

least 2 containers per trailer by receiving foreman at the receiving dock for each delivery of beef 

trimmings.

Inspection of Containers

100% visual inspection of shipping container condition by the receiving foreman.

Corrective Actions

If the required documentation does not accompany the shipment of beef trimmings, placed on 

“hold” until the required documentation is received.

If the temperature of beef trimmings is above 40°F, the supplier may provide evidence which 

demonstrates the temperature of the beef trimmings from time of shipping to receipt was above 

40°F for no more than 2 hours but never above 50°F.

Beef trimmings with damaged containers are segregated and placed in “Product Reinspection” 

area for further evaluation.

Records

1. Receiving Log

2. Bills of Lading

3. Letters of Guaranty

Receiving Log

Date Supplier Product Lot Codes Temperature 

(trimmings)

Condition 

(Acc or 

UnAcc)

Receiving 

Initials

1-25-2019 Open 

Beef

5combos 

beef trim

Lot 012416AC 38, 40 Acc EP

... ... ... ... ... ... ...

Corrective Actions:

For Training Purposes Only
146

OpenBeef Co,Inc.

STRAIGHTBILLOF LADING

8305 Hawthorne Way

Petaluma, CA 94954

CONSIGNED TO: SPECIAL INSTRUCTIONS

Groveton Meats, Inc. 

1200 Presley Drive 

Los Angeles,CA94852 Trailer Temp: 34 degrees F

Pallets Used S.O. Number Seal Numbers Ship Date Delivery Date

799 23012/931 1-24-19 1-25-19

Piece Count Description Weight

5 Combos – Beef Trimmings 

Lot 012416AC

2476 lbs.

Total Pc Cnt: 5 Driver Initials: J T Total Wt: 2476 lbs.

Note: This shipment contains beef products derived only from animal determined to be less than 30 

months of age and contains no SRM’s such as tonsils or distal ileum.

SHIPPER: Open Beef Co. CARRIER: Open Beef Co.

PER: J T PER: J T 

DATE: _1-25-19

Date B/L #

1-24-19 25744
147

February 2, 2011

DearCustomer,

As part the Food Safety System at Open Beef, we apply a validated antimicrobial organic acid 

rinse to all of our carcasses and variety meats. Thisletter is to convey the results of Open Beef 

Co, Inc. E. coli O157:H7 “Verification” testing. We perform verification testing of trimmings 

that will be used as raw ground beef components to provide ongoing validation of our Food 

Safety system. We use the N-60 sampling method to collect our samples and the contract lab 

utilizes test methods which are equivalent in sensitivity to FSIS methods. 

Current Results:

Lot Number – 012416AC 

Production Date: 01/23/19 

Sample Date: 01/23/19 

Shipment Number – 25744 

Trailer Number – T43

N60 SampleResult: NEGATIVE for E. coli O157:H7 

Result Received: 01/24/19 

Contract Lab: JDL Laboratories, Inc.

Please contact me if you have any further questions.

Bert Earnest

Bert Earnest

Director of Quality Assurance

Petaluma, CA 

700-777-7000

“Where Good Beef Is Found” TM 

For Training Purposes Only
148

20 Sampling Requirements to Demonstrate Process Control in Slaughter Operations

Objectives:

1. Explain why generic E. coli sampling and analysis is performed in livestock (other than swine) 

slaughter operations.

2. Explain why microbiological sampling and analysis is performed in swine and poultry slaughter 

(other than ratite) operations.

3. Identify who is responsible for selecting and analyzing livestock (other than swine) samples for 

generic E. coli.

4. Identify who is responsible for selecting and analyzing swine and poultry samples for 

microbiological analysis.

5. Explain the purpose of performance criteria and statistical process control.

6. Describe how to verify the regulatory requirements for generic E. coli testing when conducting the 

Generic E. coli verification task.

7. Describe how to verify the regulatory requirements for microbiological sampling and analysis of 

swine and poultry slaughter when conducting the appropriate PHIS inspection verification task.

8. Explain the appropriate enforcement actions to take when noncompliance is found while performing 

the generic E. coli verification task or the appropriate swine and poultry slaughter inspection 

verification task.

Generic E. coli Testing for Livestock, (other than swine)

Each official establishment that slaughters livestock, otherthan swine, orratites is required 

to test for Escherichia coli Biotype I, also known as “generic E. coli.”

Note: Swine and poultry (other than ratite) will be covered in the next section.

Fecal material is one of the principal sources of pathogenic organisms

(Salmonella, Campylobacter, and E. coli O157:H7) that contaminate carcasses. The best 

indicator of fecal contamination is Escherichia coli, Biotype I, also called generic E. coli, 

because it is commonly found in the intestinal tract of food animals. The purpose of generic

E. coli testing is to verify the effectiveness of sanitation and process control in slaughter establishments.

Note: Generic E. coli is not a pathogen.
149

FSIS has developed performance criteria for some species (not all of them), and specifies 

approved sampling techniques, such as for beef using excision sampling.

• There are two sampling methods that are used: excision and sponging.

o Excision – This is the method described in the regulation; rarely used because it 

is a destructive method, only need to excise the surface, so it’s not necessary to 

do a deep cut.

o Sponging – The most commonly used since it is a non-destructive method.

o Hide-on carcasses are not excised – The regulations are specific that these are 

only sponged.

Performance criteria – These are numbers published in the regulations that represent the 

highest expected microbial loads on carcasses when the slaughter process is under control. 

The performance criteria give livestock slaughter establishments guidance (not 

enforceable) about the effectiveness of their slaughter sanitary dressing procedures in 

preventing fecal contamination. Test results that meet the criteria in the regulations provide 

evidence that the establishment is maintaining adequate process control for fecal contamination 

and sanitary dressing.

Establishment Procedures - The establishment is to collect samples from the type of livestock 

that it slaughters in the greatest number. Livestock samples are collected after they have been 

in the cooler for 12 hours or more. However, carcasses can be selected while on the rail or 

after the final wash and set aside in a convenient spot in the cooler for testing after 12 hours. 

For hot boning: Samples are taken after the final wash prior to boning. Samples are taken 

before the carcasses enter the processing department.

• There are 3 required sample sites or anatomical locations on the carcass, which are 

the flank, brisket, and rump.

• The frequency is based on the number of carcasses. Regulations require that carcasses for 

sampling be selected at random.

• Generic E. coli tests are reported as a quantity or bacterial concentration. The units of 

measure must match the testing technique used to ensure that results are reported 

correctly.

• Establishments are required to keep a table or a chart of the results for at least the 

most recent 13 test results.

If the Agency does not have performance criteria published for the species being tested or for the sampling
150

technique being used, establishments must use statistical process control (SPC) to develop criteria to 

compare their samples results. The performance criteria in the regulations are referenced as “m” and “M” 

values. Thus, cattle establishments collecting excision samples must use the m/M values prescribed in 

the regulations. However, most establishments use sponging, so this means most establishments 

must use SPC. There are practically no establishments which can use m/M because it is only applied to 

excision sampling.

Establishments must use statistical process control (SPC), to develop their own criteria, 

to evaluate their test results when they slaughter species or use sampling techniques for 

which the Agency has not developed performance criteria. IPP are not to focus on the 

particular method the establishment uses to set process control criteria. Instead, they are to 

review the generic E. coli testing results and verify that the establishment has set generic E. coli 

criteria to define process control and responds to results outside those criteria.

Under the regulations, establishments are not required to take corrective actions or to document the 

necessary actions for E. coli test failures. However, when livestock slaughter establishments do not 

evaluate their test results (9 CFR 310.25(a)(5)), they might not be maintaining slaughter process 

controls sufficient to prevent fecal contamination.

Note: The livestock (other than swine) slaughter establishment’s generic E. coli testing results 

cannot, by themselves, support a finding of noncompliance with 9 CFR 310.25(a) However, if the 

establishment’s testing results indicate a failure of process control, IPP are to verify the establishment’s 

sanitary dressing procedures.

IPP perform the livestock Generic E. coli task, select the regulatory requirement to verify and 

determine whether the establishment is in compliance or noncompliance with the regulations.

• IPP are to verify that the establishment maintains daily records documenting the 

implementation and monitoring of its procedures, makes these records of the tables and 

charts with generic E. coli test results available for review, and retains these records 

for one year.

• If IPP find noncompliance, they are to notify the establishment and document the 

noncompliance in an NR citing the appropriate regulation.

• Establishment test results that show lack of process control should be considered in 

conjunction with other information, like sanitary dressing procedures, zero tolerance, 

SSOP, and any other HACCP performance criteria.
151

• Further enforcement action might be necessary if the establishment has 

repetitive NRs, or if the establishment’s corrective actions are ineffective. IPP 

are to discuss with their immediate supervisor the need to take an enforcement action 

outlined in FSIS Directive 5000.1.

Microbiological Sampling for Poultry (other than Ratite) and Swine Slaughter Operations

Establishments that slaughter poultry, otherthan ratites, and swine are required to 

perform microbiological sampling and analysis, for example, testing for Salmonella, 

Campylobacter, or indicator organisms such as aerobic plate count (APC), total coliform, 

Enterobacteriaceae, and Escherichia coli, Biotype I, also known as generic E. coli.

Because establishments have differences in their operations, each establishment has the flexibility to 

develop a sampling plan and determine the microbial organism that will accurately monitor the 

effectiveness of its process control procedures. Establishments MUST incorporate their written 

process control procedures into their HACCP system, either in the HACCP plan itself, as 

sanitation SOPs, or as a prerequisite program.

Microbiological test results that represent the level of microbiological contamination at key steps in the 

slaughter process are necessary for the establishment to provide comprehensive objective evidence to 

demonstrate process control. Process control consists of the programs and procedures that an 

establishment implements to ensure its process prevents contamination of poultry and swine 

carcasses, including contamination with pathogens and fecal material.

Note: The required location where the sample is collected, and frequency of sampling depend on 

species and size of establishment.
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IPP are to verify that the poultry or swine slaughter establishment:

• Developed a written sampling program that identifies the specific microorganisms being 

tested and location/frequency where samples are collected,

• Incorporated its written sampling program for preventing contamination by enteric 

pathogens into its HACCP system,

• Implements and maintains its written sampling program,

• Maintains scientific and technical documentation to support the decisions that the 

establishment made in designing the sampling program,

• Maintains daily records documenting the implementation and monitoring of its 

procedures including sample results,

• Take actions to restore or improve process control when sample results indicate problems 

with establishment slaughter HACCP system.

Noncompliance occurs when the establishment is not meeting the prescribed regulatory requirements; 

is not following its written sampling and testing procedures; does not demonstrate that it is 

maintaining process control; or its corrective actions are not effective.

If the establishment has repetitive NRs, or the establishment’s corrective actions are ineffective, IPP 

are to discuss with their immediate supervisor the need to take an enforcement action outlined in FSIS 

Directive 5000.1., Chapter V.
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21 Humane Handling Verification for Livestock and 

Good Commercial Practices for Poultry

Objectives:

1. Name the two approved methods of slaughter in the Humane Methods of Slaughter Act (HMSA).

2. List the steps in performing the Livestock Humane Handling Verification task using the Public Health 

Information System (PHIS).

3. List the Humane Activities Tracking System (HATS) categories and give one example of each.

4. Given a specific scenario, be able to identify regulatory noncompliance, whether it is egregious, and 

what action to take, if any.

5. Describe the actions an inspector should take when he/she observes a non-egregious incident of 

inhumane treatment resulting from: Facility deficiencies, disrepair or equipment breakdown, 

establishment employee actions in handling livestock, or improper stunning.

6. Define egregious noncompliance, give examples and describe the action taken in response.

7. Name the documents completed for non-egregious and egregious noncompliances.

8. List the steps in performing the Poultry Good Commercial Practices (GCP) task.

9. Identify regulatory noncompliance with Good Commercial Practices or mistreatment of birds and 

actions to take in each case.

The Humane Methods of Livestock Slaughter Act (HMSA) of 1978 made the humane slaughter and 

handling of livestock mandatory in connection with slaughter of all food animals slaughtered in 

USDA inspected establishments.

The two approved methods of slaughter are:

• Livestock must be rendered insensible to pain on the first application of the stunning device 

before being shackled, hoisted, cast, or cut. This means that the animal must be unconscious 

and unable to feel pain before it is “stuck” (veins and arteries severed so it bleeds out) before 

it is shackled and hoisted into the air, or before it is dropped onto a table/floor.

• The ritual requirements of any religious faith that prescribes a method of slaughter whereby 

the animal suffers loss of consciousness by anemia of the brain caused by the simultaneous 

and instantaneous severance of the carotid arteries with a sharp instrument. This method is 

known as ritual slaughter. In ritual slaughter, the animal’s throat is cut from side to side with a 

sharp knife, deeply enough for the major arteries and veins to be severed. Examples of ritual 

slaughter include Jewish (kosher) slaughter and Islamic (halal) slaughter.
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Livestock Humane Handling Verification Task

In livestock slaughter establishments, you will verify compliance with the Humane Handling 

regulations by performing the Livestock Humane Handling Verification task. This task must be 

performed once per shift, every shift animals are slaughtered or on-site.

Recording Time in HATS (Humane ActivitiesTracking System)

You are to accurately and completely record the time that you spend on the nine specific HATS 

categories.

• Record the total time spent verifying each HATS category, in quarter hourincrements, rounding 

up to the next quarter hour.

• There should be an entry of at least one-quarter hour in HATS Category IV – “Antemortem 

Inspection” for every slaughter shift except in very small establishments (see below).

• In addition, verify one or more of the other HATS categories during each slaughter shift. Ensure 

that, over time, all HATS categories are verified, and the appropriate time recorded.

• During normal operations, the total maximum time entered across all HATScategories will 

generally not exceed the total operational hours for that respective shift.

At many very small establishments, the total amount of inspection time spent on HATS procedures, 

including observations at antemortem inspection, may only total .25 hour (or less). Therefore, IPP 

should record .25 hour per day in a different HATS category each slaughter day. Note: Antemortem 

Inspection must still be performed when animals are presented for slaughter, even if you do not 

record HATS time.

9 HATS Categories

I. Inclement Weather: Some things to look for include:

• Animals slipping or falling because of wet floors.

• Livestock overheated because of a lack of proper shade or because of a lack of water for 

cooling.

• Disabled livestock not in a covered pen protected from the elements.

II.Truck Unloading: Some things to look for include:

• Vehicles or ramps not being properly positioned, leading to the injury of animals.

• Animals forced to move faster than a normal walking speed.

III.Water and Feed Availability: Some things to look for include:

• Water not accessible to livestock in holding pens.

• Feed not provided to livestock held for longer than 24 hours.

• Feed provided not appropriate for species and age.
beginning to regain sensibility on the bleed rail. 155

Note: If animal appears exhausted and/or dehydrated refer to the Twenty-Eight Hour Law. 

The Animal and Plant Health Inspection Service (APHIS) Twenty-Eight Hour Law requires 

transporters to stop at least every 28 hours to provide animals with food, water, and rest, and 

those who do not are in violation of this law. Consult with your supervisor if you have 

concerns about the condition of the animals being delivered.

IV. Handling during Antemortem Inspection: Some things to look for include:

• Livestock being injured because of handling practices.

• Livestock being moved faster than a normal walking speed.

V.Suspect and Disabled: Some things to look for include:

• Conscious animals being dragged.

• Disabled animals not separated from normal ambulatory animals.

• US Suspect and disabled livestock are not provided or placed in a covered pen.

VI.Electric Prod/Alternative Object Use: Some things to look for include:

• Livestock being excessively prodded resulting in overexcitement or injury.

• Livestock being driven with sharp objects or other means which cause pain or injury.

VII.Slips and Falls: Some things to look for include:

• Livestock slip and fall due to inadequate footing or improper handling practices (typically 

observed during movement of animals after ante-mortem inspection).

• Livestock slip and fall because of lack of slip-resistant flooring.

VIII. Stunning Effectiveness: Some things to look for include:

• Livestock not rendered unconscious with a single application of the stunning methodology.

• Use of secondary entrances with potential for injury (or actual injury) of livestock.

There are some general principles that apply to all stunning methods:

1. Stunning equipment must be maintained in good repair. Equipment in poor repair can interfere 

with the rapid and effective application of the stunning blow. This can result in an incomplete or 

unsuccessful stun.

2. Effective stunning requires effective restraint. If an animal is not effectively restrained, it will be 

much more difficult to locate the stunning blow with a high degree of accuracy. The stunning 

area should be designed and constructed to limit the free movement of animals.

3. A well-trained and experienced establishment employee must operate stunning devices. The 

employee must be able to accurately and consistently position the stunning devices so that the 

animal is rendered immediately unconscious.

4. Animals need to be delivered to the stunning area with a minimum of excitement or discomfort. It 

is more difficult to place the stunning device accurately, and the method of stunning may not work 

as effectively, on an excited or injured animal.

With any stunning method, it is important to observe the amount of time it takes for the animal to 

begin bleeding out (“sticking”) after being stunned. Although there is no regulatory requirement for 

this time period, if the “stun-to-stick” interval is prolonged, it could result in animals regaining or
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The regulations describe four acceptable methods for producing a state of surgical anesthesia (surgical 

anesthesia is defined as a state where the animal feels no painful sensations). The four acceptable 

methods are:

1. Chemical (carbon dioxide - CO2)

2. Mechanical (captive bolt)

3. Mechanical (gunshot)

4. Electrical (electrical current)

Some signs of a properly stunned animal (but not limited to):

• The head and neck of the animal are floppy.

• The tongue is limp and hanging straight down out of the mouth.

• There is no vocalization-bellowing or squealing.

• The eyes are wide open with a blank stare.

IX. Conscious Animals on the Rail: Some things to look for include:

• Processing (e.g., shackling, hoisting, cutting) livestock not rendered unconscious by the 

method of stunning.

• Animals regaining consciousness after being stunned. If you observe an animal 

regain consciousness after stunning, you must contact your supervisor 

immediately.

RitualSlaughter(HMSA - HumaneMethodsofSlaughterAct)

The ritual slaughter cut and the handling and restraint that immediately precedes that cut is often called 

the “ritual bubble”. The activities that occur within that “ritual bubble” fall under Section 1906 of the 

HMSA and are protected as part of the Constitutional right of religious freedom. This does not mean 

that Agency personnel are to ignore completely what happens within the “ritual bubble”—what it 

means is that Agency personnel don’t enforce humane handling regulations within that “ritual bubble”.

It is important to understand that ritual slaughter establishments are required to meet all the humane 

handling regulatory requirements except stunning prior to shackling, hoisting, throwing, cutting, or 

casting. A few ritual slaughter establishments elect to apply one of the approved stunning methods 

either before or after the ritual cut. In such establishments, IPP will also verify the stunning 

effectiveness HATS category. All animals must be unconscious or insensible to pain prior to any 

dressing procedures such as head skinning, leg removal, ear removal, horn removal, or opening 

hide patterns.

Odd-Hour Verification Visits

The IIC, in conjunction with the FLS and DVMS, determines how frequently IPP need to perform oddhour inspection to observe the livestock facilities and handling practices. These visits are 

unannounced and outside of operating hours.
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Robust Systematic Approach

There is no regulatory requirement for an establishment to use a systematic approach to humane 

handling and no requirement that such approach, if used, be in writing. However, an establishment 

may choose to develop and implement in a robust way a written animal handling program that 

effectively addresses the four aspects of a systematic approach that FSIS outlined in the 2004 

Federal Register Notice. For a systematic approach to be considered “robust” it would have to be 

written. These four steps are:

• Conduct an initial assessment of where, and under what circumstances, livestock may experience 

excitement, discomfort, or accidental injury while being handled in connection with slaughter, and 

of where, and under what circumstances, stunning problems may occur;

• Design facilities and implement practices that will minimize excitement, discomfort, and accidental 

injury to livestock;

• Evaluate periodically the handling methods the establishment employs to ensure that those 

methods minimize excitement, discomfort, or accidental injury and evaluate those stunning 

methods periodically to ensure that all livestock are rendered insensible to pain by a single blow; 

and

• Respond to the evaluations, as appropriate, by addressing problems immediately and by 

improving those practices and modifying facilities when necessary to minimize excitement, 

discomfort, and accidental injury to livestock.

If the establishment has a robust systematic approach, FSIS will take that into consideration should 

it be necessary to determine how to proceed when an incident occurs that involves egregious 

inhumane treatment.

Enforcement

The thought process that you should follow when performing the Livestock Humane Handling 

Verification task includes:

• Is there noncompliance?

• If so, is it egregious?

• What action should be taken?

If you observe a humane handling noncompliance, you must take immediate action if 

animals are being harmed. For example, if you observe an employee driving livestock with an 

instrument (e.g., the edge of a shovel, a pointed metal prod) that can cause injury, your first priority 

is to stop that action from continuing.

Once that is done, your next step is to decide if the noncompliance is egregious or non-egregious, 

because the actions you take will be dictated by that determination. An egregious humane handling 

violation is so serious that it warrants an immediate suspension of the assignment of inspectors 

under the authority of the Rules of Practice (9 CFR 500.3(b)).
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Non-egregious Noncompliances

When a noncompliance is observed, 9 CFR Part 313.50 specifies a progression of enforcement actions 

allowing for an escalating response by IPP when the establishment does not comply with the humane 

slaughter of livestock regulations.

• First, notify establishment managers of the humane handling noncompliance, if not already done 

when addressing the needs of the animal.

• Second, request that establishment managers immediately correct the situation and take the 

necessary steps to prevent recurrence.

• Third, document the noncompliance on a noncompliance record (NR).

If necessary, take a regulatory control action (RCA) to prevent further injury to the animal(s) 

or to prevent injuries from occurring to other animals. You will also take the appropriate regulatory 

control action if you do not receive an adequate response or corrective actions to the NR or if the 

noncompliance observed continues to occur. The appropriate regulatory control action depends on 

the nature of the noncompliance. Remember that the goals of applying a tag are to control the 

situation and prevent further injury or distress to animals.

• If the noncompliance is the result of facility deficiencies, disrepair, or equipment breakdown, but is 

not immediately causing injury or distress to livestock, attach a U.S. Retained / Rejected tag to the 

noncompliant equipment/pen/etc. Noncompliance examples include holes in pen floors or fences 

that can trap/injure an animal’s legs or feet.

 If the noncompliance is the result of establishment employee actions in the handling or movement of 

livestock and animals are being injured or treated inhumanely, attach the tag either at a point specific 

to the location and nature of the violation or to the alleyways leading to the stunning area. 

Noncompliance examples include animals driven faster than a normal walking speed or animals 

slipping and falling because of slick floors.

The tag will remain in place until the establishment operator implements appropriate 

immediate actions and measures to prevent recurrence. The tag shall not be removed by anyone 

other than an inspector. All livestock slaughtered prior to the tagging may be dressed, processed, or 

prepared under inspection.

Whenever a non-egregious noncompliance of the humane slaughter requirements is observed, 

inspection personnel must document the incident on a NR and send a copy to the DVMS at the 

District Office. It is important that it clearly and specifically describe exactly what was observed, 

including any response by the animal (if the noncompliance involved animal discomfort or injury). 

Specify all the relevant regulations that pertain to the incident. At the top of Block 10 (where the 

noncompliance is described) on the NR, list the HATS category you were performing when you saw 

the noncompliance. If the noncompliance is covered by a second HATS category, note both 

categories on the NR. Note: The HATS categories do not have to be listed at the top of Block 10, 

but they must be clearly stated somewhere in the description narrative.
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If the establishment continues to have noncompliances or does not adequately correct previously 

documented noncompliances, the IIC is to communicate this to the FLS and DVMS. The IIC will 

work with the FLS and DVMS to determine if a Notice of Intended Enforcement (NOIE) should be 

issued for multiple noncompliances.

More examples of non-egregious noncompliances (include, but not limited to):

• There are sharp corners, holes or fence gaps in which animals may be injured.

• There are protruding rails or sharp objects which may injure animals.

• There are issues with access to water or feed.

• There is driving of animals off a high step, causing some to slip or fall.

• There is excessive use of prods, causing undue excitement but not pain or injury

Egregious Noncompliances

So, what is an egregious noncompliance? Webster’s Dictionary defines “egregious” as 

“conspicuously bad or flagrant.” The Agency defines it as “any act or condition that results in severe 

harm to animals.”

If you observe a noncompliance that you believe is egregious, your next set of actions will depend on 

whether or not you are the IIC. If you are the IIC, place a U.S. Retained/Rejected tag at the 

appropriate place and inform establishment managers that you are communicating with the 

FLS, District Office and DVMS to discuss the incident and recommend that a suspension without 

notification is imposed in accordance with 9 CFR 500.3(b).

If you are not the IIC, attach a U.S. Retained/Rejected tag at the appropriate place, and inform 

establishment managers that you are taking a regulatory control action and that no more 

animals can be slaughtered until you contact the IIC. Whichever action is taken, all livestock 

slaughtered before the action may be dressed, processed, or prepared under inspection.

NOTE: Regardless of whether or not you are the IIC, your very first step—even before 

applying a tag—is to stop the activity that is causing harm to animals.

The IIC will immediately notify the FLS, District Office and the DVMS of the incident to discuss

and recommend a suspension action.

The IIC will also document the facts that serve as the basis of the suspension action on a 

noncompliance record (NR) and promptly provide that information electronically to the DO and the 

DVMS for their use. The NR will form the basis of the Notice of Suspension documented by the 

DVMS and DO staff and of the Administrative Enforcement Report.

Examples of egregious noncompliances (include, but not limited to):

• Making cuts on or skinning conscious animals;

• Excessive beating or prodding of ambulatory or non-ambulatory disabled animals or dragging 

of conscious animals;

• Stunning of animals and then allowing them to regain consciousness;

• Failing to immediately (or promptly) render an animal unconscious after a failed initial 

stunning attempt (e.g., no planned corrective actions);

• Leaving disabled livestock exposed to adverse climate conditions while awaiting disposition.
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Poultry Good Commercial Practices (GCP) Verification Activities

Poultry (chickens, turkeys, ducks, fowl, etc.) are not subject to the humane handling regulations as 

discussed above for livestock. Rather, compliance or noncompliance is determined based on a 

single regulation that prescribes that birds must be slaughtered under a well-controlled process that 

ensures they are bled out and no longer breathing by the time they enter a scald tank. 9 CFR 

381.65(b) reads as follows:

“Poultry must be slaughtered in accordance with good commercial practices in a manner that will 

result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to 

scalding. Blood from the killing operation must be confined to a relatively small area.”

IPP assigned to poultry slaughter facilities are expected on a daily, per shift basis when the 

establishment slaughters, to perform a Poultry Good Commercial Practices task.

If the poultry are stunned prior to bleeding, check the stunning equipment to ensure it is functioning 

properly. Poultry that have been effectively stunned will have an arched neck and tucked-in wings 

posture.

Check in the bleeding area to determine if the bleeding equipment is functioning properly. One way 

that you might be alerted to problems with the bleeding equipment is if the line inspectors report an 

increased number or clusters of cadavers at inspection stations or increased numbers of bruised 

wings or legs.

Once a week, IPP are to randomly select a day to review establishment records documenting 

adherence to good commercial practices. This review takes the place of observation in the receiving 

through pre-scald areas. Recognize that establishments are not required to maintain written records 

of good commercial practices. If records are not kept, IPP are to visit the receiving through prescald areas as above.

Enforcement

During poultry handling and slaughter, IPP are to document through NRs or MOIs establishment 

failure to follow GCP. From a regulatory perspective, adherence to GCP is a process control issue 

and not a bird-by- bird performance standard issue.

If the establishment is not following good commercial practices, and birds are dying other than by 

slaughter, you are to document a noncompliance record citing 9 CFR 381.65(b), using the Poultry 

Good Commercial Practices task in PHIS. IPP are to write NRs for GCP noncompliance only 

when they can demonstrate that an establishment has lost process control and that there is an 

ongoing trend of bird dying otherwise than by slaughter.
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Poultry Mistreatment MOIs

Poultry mistreatment MOIs are issued when the establishment is mistreating birds up until the kill 

step, but the mistreatment event does not demonstrate that the establishment’s process is out of 

control. The MOI documents the discussion between IPP and the establishment management about 

the poultry mistreatment event. In addition, you are to document the discussion and any planned 

actions on the part of the establishment in a MOI. Give a copy of the MOI to establishment 

managers, keep a copy in the inspection file, and send a copy to the DVMS.

DVMS - District Veterinary Medical Specialist

The District Veterinary Medical Specialist (DVMS) will review the MOIs and GCP NRs and determine 

if additional action is warranted. If you have questions or concerns about what you observe during 

poultry slaughter, contact the DVMS for guidance.
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22 Sanitary Dressing

Objectives:

1. Define:

a) Process control procedures

b) Sanitary dressing procedures

c) Contamination of carcasses and parts

2. Describe the role of sanitary dressing and process control procedures as part of an 

establishment’s food safety system.

3. Identify points in the slaughter process where contamination is most likely to occur.

4. Explain how to verify that slaughter operations are implementing appropriate sanitary 

dressing procedures to prevent contamination.

5. Explain how to verify that establishments are properly applying intervention treatments.

6. Describe how to use a system-based approach to determining compliance.

Inspection program personnel (IPP) who perform off-line slaughter verification duties are to use 

the PHIS Beef Sanitary Dressing task to verify compliance with the sanitation performance 

standards. They need to gather as much information as possible for a sound regulatory decision 

about the system. As IPP enter the kill floor, they observe the process, review plant records 

and results, FSIS records and results, NRs, pathogen testing results, generic E. coli testing 

results, online IPP feedback, weather conditions, etc. The thought process should use the 

systems-based approach to make compliance determinations.

Sanitary Dressing: Practice of handling carcasses by establishment employees and 

machinery, throughout the slaughter process, in a manner that produces a clean, safe, 

wholesome meat food product in a sanitary environment.

Process Control Procedure: A defined procedure or set of procedures designed by an 

establishment to provide control of operating conditions that are necessary to produce safe, 

wholesome food. The procedures establishments follow typically include observing or 

measuring system performance, analyzing the results to set control criteria, and acting when 

needed to ensure that the system continues to perform within the control criteria. The 

procedures would include planned measures taken by the establishment in response to any 

loss of process control. In addition, the procedures can be used as support for decisions made 

in the hazard analysis.
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Contamination of Carcasses and Parts: Carcasses and parts are deemed contaminated, 

based on organoleptic inspection if they have been prepared, packed, or held under 

insanitary conditions. Contamination can originate from two sources:

• Extraneous Substances: Substances not related to the species being slaughtered like 

oils, rail dust, condensate, and unidentified foreign material.

• Intrinsic Sources: substances related to the species being slaughtered, like digestive 

content, milk, ingesta, or bile. Establishments need to prevent the creation of insanitary 

conditions and prevent the contamination of carcasses and parts to meet regulatory 

requirements.

Effective sanitary dressing and process control procedures lay the foundation for the 

critical control points (CCPs) that prevent, eliminate, or reduce to an acceptable level food 

safety hazards that are deemed reasonably likely to occur in the slaughter process. It is the 

responsibility of the establishment to reduce E. coli O157:H7 to below detectable levels and 

reducing the amount of contamination that is present on a carcass helps the establishment 

accomplish that.

Note: Positive results can be attributed to ineffective sanitary dressing and process 

control procedures that lead to insanitary conditions during slaughter.

Establishments must operate and be maintained in a manner sufficient to prevent the creation of 

insanitary conditions and to ensure the product is not adulterated, as required by 9 CFR 416.1-

416.5. Establishments that slaughter cattle must do so in a manner designed to prevent 

contamination from occurring at any step in the process. SPS plays a role, especially with regard to 

equipment / utensils, sanitary operations, employee hygiene. SPS is the most appropriate 

category for addressing incidental contamination.

Each establishment must design their own procedures. Effective sanitary dressing and 

process control procedures, coupled with effective decontamination and antimicrobial 

intervention treatments, are needed to prevent the creation of insanitary conditions.

Establishments that fail to control these procedures and treatments create the potential for 

carcass contamination in their food safety systems. Establishments may elect to maintain 

written sanitary dressing and process control procedures as part of their HACCP Plan, 

Sanitation SOP, Good Manufacturing Practices (GMP), or other prerequisite programs. If the 

sanitary dressing procedures are used to support decisions made in the hazard analysis in 

accordance with 9 CFR 417.5(a)(1), establishments must maintain records addressing the
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sanitary dressing and process control program. The records must demonstrate that the 

program is effective and thus decisions made in the hazard analysis can be supported on an 

on-going basis. Establishments have flexibility on how they demonstrate effective sanitary 

dressing and maintain records.

Verification of a food safety system requires that IPP evaluate production operations by 

looking at all aspects of those operations and assessing the interactions between them 

using a systems-based approach. IPP accomplish this through observation of the 

implementation of a variety of plans and procedures and through the review of documents 

associated with those plans and procedures. When the information gathered suggests that the 

establishment has lost process control, IPP are to determine if the establishment has taken 

measures to restore process control.

FSIS has identified the points in the slaughter process where carcasses are most vulnerable 

to contamination. This was determined through scientific literature review as well as best 

practice guidance created by industry. The steps are: live receiving/holding, sticking, hide 

removal, wash cabinets, bunging, head removal, rodding the weasand, evisceration, carcass 

splitting, and head and cheek meat processing. When cattle arrive, there is an increased 

potential for contamination with enteric pathogens such as E. coli O157:H7 and Salmonella due 

to their presence on the hide and in feces. Stressors cause increase shedding of pathogens like

E. coli O157:H7.

An intervention is a step in the process added for the purpose of eliminating/reducing a 

hazard to an acceptable level. How well the establishment performs its sanitary dressing 

procedures impacts whether the antimicrobial intervention treatments will be effective and 

accomplish their intended results. Intervention may be a sprayed solution of water and/or 

chemicals, a shower, some sort of drip application, steam vacuum device, a combination of all 

of these—the multiple hurdle approach. Each one of these interventions has a certain 

capability. Sanitary dressing directly impacts whether antimicrobial treatments will accomplish 

intended results. When incoming contamination overwhelms the antimicrobial properties of 

the intervention treatments, reduction of E. coli O157:H7 may no longer meet the 

standard of reduction to an undetectable level.

FSIS has questions about the establishment’s ability to support the food safety system as the 

hazard analysis anticipates, unless the establishment has: documentation that supports that the 

food safety system at slaughter, including sanitary dressing procedures coupled with all
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intervention treatments, is effective under the actual conditions that apply in its operation; the 

establishment has reassessed its system in response to new or revised procedures or 

interventions that have been implemented and has determined that no changes were needed. If 

the establishment determines it can prevent contamination through its SOP, GMP or other 

prerequisite program, it needs to include support in the hazard analysis. Before you make a 

compliance (meets regulatory requirements) determination, base it on in-plant observations, your 

own test results, establishment results, FSIS results, and communication with other inspectors; 

on-line IPP and PHV/SPHV findings, historical information; NRs, MOIs, ongoing noncompliance 

related to zero tolerance, increased contamination based on environmental conditions, positive 

pathogen results, and feedback from on-line IPP indicating increased contamination.

Regulations to cite include 9 CFR 310.18(a) for carcass contamination, and 9 CFR 416.1 

(remember: only cite this regulation in response to egregious and repetitive insanitary 

conditions, and only in consultation with your IIC and FLS). Include in the description of the 

noncompliance the appropriate SPS regulations to address the source(s) of the insanitary 

condition. Noncompliance is not likely to be documented in response to one 

contamination incident or one single point in the process. Review NRs to determine if a 

trend is developing. NRs can be associated as necessary in accordance with the 

instructions in FSIS Directive 5000.1.
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23 Review of Establishment Data Task

Objectives:

1. Explain the purpose of the Review of Establishment Data task

2. Identify the kinds of records that are subject to review during this task

3. Describe how to assess the significance of information gathered during this task

4. Explain how to follow-up on questions or concerns identified

5. Explain how to document the task in PHIS

6. Describe what is done if the establishment management refuses access to records

What Data do IPP Review and Why?

Establishments may conduct certain testing or monitoring activities that are not a part of their 

HACCP plans or Sanitation SOPs. For example, establishments may perform testing or 

monitoring activities as a part of a prerequisite program or conduct product testing to comply 

with certain specifications of its customers. Data generated by such activities may not even be 

referenced in a hazard analysis. Nonetheless, these activities may provide information relevant 

to the effectiveness of establishments’ food safety systems. In other words, the data may raise 

questions or concerns about the adequacy of an establishment’s hazard analysis.

Whenever the results of testing and monitoring activities provide information relevant to the 

adequacy of decisions made in a hazard analysis, FSIS considers records of these results to be 

supporting documentation for that hazard analysis. Such records must be maintained by the 

establishment and made available for FSIS review. A prudent establishment will consider the 

significance of this information with respect to the overall effectiveness of its food safety system 

and respond to the results as necessary.

IPP should be aware of all monitoring and testing related to food safety conducted by an 

establishment, including monitoring and testing not referenced in the hazard analysis and not 

included as components of the establishment’s Sanitation SOPs or HACCP plan. FSIS 

Directive 5000.2 specifies that at least once per week, IPP are to review the results of any such 

monitoring and testing. In this training module, we discuss the methodology for reviewing such 

data. The Review Establishment Data task helps IPP gain a full understanding of the 

establishment’s food safety system. Considering the significance of this information in the 

context of the establishment’s food safety system may identify potential vulnerabilities that 

otherwise may not be recognized when performing other HACCP and sanitation inspection 

tasks.
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Records Subject to the Review Establishment Data Task

The Federal Meat Inspection Act (Section 642) and the Poultry Products Inspection Act (Section 

460(b)) both establish the legal authority for requiring establishments to maintain a broad range 

of records. In addition, the Acts provide FSIS the authority to access any required records as 

necessary. FSIS has made clear to the regulated industries that IPP have the authority to 

access all establishment records that could disclose the existence of an insanitary 

condition which needs to be addressed in an establishment’s HACCP plan, Sanitation SOPs, 

or prerequisite programs.

The regulatory authority to have access to records, which may have some bearing on the 

hazard analysis, derives directly from 9 CFR 417.5(a)(1), which states that an establishment 

must maintain the written hazard analysis prescribed in 9 CFR 417.2(a) and all supporting 

documentation. Furthermore, establishments are required by 9 CFR 417.5(f) to make all records 

required by 9 CFR 417 available for official review.

The purpose of a hazard analysis is to identify all relevant hazards and to determine which are 

reasonably likely to occur (RLTO) in the production process (9 CFR 417.2(a)(1)). A hazard 

analysis (and any documentation supporting the decisions in that hazard analysis) is not 

intended to be a static document. At any time, additional information or data may call into 

question the adequacy of an establishment’s hazard analysis. This information or data may not 

be specifically referenced in the hazard analysis or generated through implementation of the 

establishment’s HACCP plan or Sanitation SOPs.

FSIS Directive 5000.2 specifies that IPP have access to any type of record maintained by the 

establishment if the record relates to the establishment maintaining its food safety system.

Establishments must decide what type and frequency of testing is necessary to support the 

decisions made in its hazard analysis. Thus, the establishment decides which testing programs 

are necessary to ensure food safety and which testing programs are unrelated to food safety. 

However, the establishment would have to explain to IPP why certain test records are not 

related to food safety and do not impact the hazard analysis. If IPP learn of a testing 

program and have questions about whether records of that testing program should be included 

in the Review Establishment Data task, they should seek guidance from their supervisors and 

askFSIS.
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NOTE: The Review Establishment Data task targets records of monitoring and testing results 

that bear on food safety, not product quality concerns. Certain regulatory product quality 

concerns would be verified through non-food safety, other consumer protection (OCP) tasks 

instead of the Review Establishment Data task.

Obviously, IPP should question why the results of any testing for pathogens conducted to meet 

purchase specifications or for other purposes would not affect the hazard analysis. It is not 

unusual, though, for many establishments to conduct testing of non-product contact surfaces or 

finished product for generic microbes such as aerobic plate counts (APCs), generic coliform 

bacteria, or other non-pathogenic microbes. Establishments may use such testing to provide 

information about product quality (e.g., shelf life) or to meet certain customer purchase 

specifications. Generally, such test results can also have implications for food safety. For 

example, if non-pathogen test results are used to ensure that the production process controls 

the overall level of microbes in the product, such test results may affect the hazard analysis, 

because the production process may be modified in response to microbial levels. In these 

situations, the test results should be made available to IPP for review. If purchase specifications 

call for testing of non-pathogens and the results are for information purposes only, those results 

would not affect the hazard analysis and generally would not have to be made available to IPP 

for review.

The types of records subject to the Review Establishment Data task are not limited to records of 

microbial testing. For example, some establishments may include metal detection in their 

process to meet some customer purchase specification. The establishment’s hazard analysis 

may reference preventive maintenance programs and visual checks for metal contamination as 

support for metal being not reasonably likely to occur, but not include the customer-required 

metal detection program as additional support. Nonetheless, the metal detection program has 

implications for food safety in such an establishment, and records associated with the metal 

detection program should be made available to IPP for review.

In addition to the results of any monitoring or test results, IPP also have access to any written 

procedures associated with those results. This would include information such as the methods 

of sample collection and analysis or the procedure for conducting some monitoring activity.
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Performing the PHIS Review Establishment Data Task

At least once a week IPP should schedule and perform the Review Establishment Data task in 

PHIS. IPP review the results of any testing that the establishment has performed that may have 

an impact on the establishment’s hazard analysis.

Gathering Information

When reviewing such monitoring and test results, inspection program personnel are to consider 

questions such as:

1. Is there documentation (paperwork) that supports the frequency of the testing that the 

establishment employs?

2. If the establishment uses the testing to reflect the effects of a prerequisite program do 

the results support the decision-making for the design of the program?

3. At what point in the process does the testing occur?

4. Does the establishment use the test results in a manner that checks the proper 

execution of some activity at the point in the process where the testing occurs? 

5. Do the results indicate that a food safety concern may be developing?

6. Is the establishment reacting to the situation? If so, what is it doing?

7. Do results indicate that a potential food safety concern is decreasing?

8. If pathogen or indicator organism positive results have decreased, does the 

establishment plan to reduce testing frequencies? If so, how it will ensure that such 

modifications to its testing program will not affect the likelihood of finding pathogens?

9. Are there operational results that correlate with the testing results? For example, does a 

reduction in microbial counts coincide with a new cleaning regimen, or conversely, has 

there been an increase in microbial counts during a time when the establishment failed 

to adequately implement some Sanitation SOP activities?
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Assessing Information

A negative response to any of the questions above does not automatically mean there is a 

noncompliance or inadequate hazard analysis. IPP are to consider all available information 

in order to make any determination as to whether there is a basis for concern about how the 

establishment is implementing its system, or about how it is reacting to the results of its testing. 

However, IPP are not to write a noncompliance record on the basis of their review of these 

records. IPP should keep in mind that the Agency’s policy is to encourage establishments to do 

testing and to address any problems that exist.

At weekly meetings with establishment management (see FSIS Directive 5000.1 and FSIS 

Directive 5010.1, Rev. 1), IPP are to raise any questions they have regarding any tests results 

that may have an impact on the establishment’s hazard analysis. When necessary, inspection 

IPP are to raise concerns through supervisory channels to the District Office.

Documenting the Review Establishment Testing Data Task

As part of documenting the weekly Memorandum of Interview (MOI), IPP are to indicate that 

they conducted the Review Establishment Data task, and that they discussed any concerns 

with the establishment at the weekly meeting. In the MOI, IPP are to:

1. Briefly list what tests results they reviewed and for what time period;

2. Describe the specific concerns, if any, that they discussed with the establishment; and

3. State how the establishment responded.

Anytime IPP have concerns about how an establishment responds to what was discussed at the 

weekly meeting or have questions about whether a particular type of data is available to the 

Agency, they are to raise those concerns or questions through supervisory channels. Frontline 

Supervisors will periodically review the documentation above and raise any concerns with the 

In-plant team and, as necessary, the District Office. Based on the concerns raised by IPP 

through supervisory channels, District Offices may determine that an Enforcement Investigation 

Analysis Officer (EIAO) needs to conduct a food safety assessment (FSA). The FSA assesses 

factors such as what the tests 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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Once IPP have conducted the Review Establishment Data task, discussed any concerns with 

plant management, and included the items above in the MOI, they are to indicate within PHIS 

that the inspection task has been completed.

Refusal of Access to Records

IPP have reported that establishments have refused to give them access to the results of 

equipment swab tests, microbiological testing of marinade solutions that are to be reused, and 

Salmonella testing. Establishments have refused to give access to these testing results on the 

grounds that the results are trade secrets—the testing is done for customers who do not want 

the results shared with the Agency, and the Agency is only entitled access to records upon 

which the establishment affirmatively relies.

The argument that the testing is a trade secret does not provide a basis not to share the 

information with FSIS. FSIS has authority and responsibility to protect trade secret information 

under the Freedom of Information Act. Such authority is meaningless unless the Agency has 

access to such information. The fact that a customer does not want the information shared with 

the Agency is irrelevant. The Agency’s HACCP regulations have the force and effect of law and 

must be followed by the establishment.

If the IPP have questions about whether a particular type of data is available to the Agency, they 

are to advise their supervisor of the situation. As indicated above, an establishment is obligated 

to provide access to HACCP plans and other establishment data in accordance with 9 CFR 

417.5(f). If an establishment refuses to provide access to its HACCP plan or other supporting 

documentation for review and recording of information into PHIS, IPP are to record a 

noncompliance, citing 9 CFR 417.5(f). IPP are then to discuss this noncompliance with 

establishment management at the next weekly meeting, and document that fact and any 

establishment response in the MOI. If the establishment continues in its refusal, IPP are to 

immediately contact their Frontline Supervisor, who will in turn inform the District Manager (DM) 

of the establishment's refusal. The DM, or designee, will contact establishment management 

and discuss the issue. If the establishment continues to refuse, the DM will instruct IPP to take 

an official control action by withholding inspection as defined under 9 CFR 500.1(b). The DM will 

then document the incident in a letter to the establishment, officially informing it that FSIS has 

withheld inspection under 9 CFR 500.3(a)(6) because the establishment has interfered with an 

FSIS inspector performing his/her inspection duties. The DM will lift the withholding action when 

the establishment has provided its HACCP plan and supporting documentation to IPP for review.
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24 Ready-to-Eatand Shelf-Stable Products Process Familiarization

Objectives

1. Define Ready-to-Eat

2. Define Shelf-Stable

3. Identify process steps that relate to the safety of fully-cooked/not shelf-stable, heattreated/shelf-stable, and not heat-treated/shelf-stable products

4. Identify factors requiring control at key process steps to meet standards for safety and 

product identity

Fully- Cooked, Not Shelf-Stable. This category applies to establishments that further process 

products by using primarily a full lethality heat process step (e.g., cooking) to achieve food 

safety. The finished products are not shelf-stable and must be frozen or refrigerated for food 

safety purposes. The products must be labeled “Keep Refrigerated or Frozen” These products 

also meet the definition of Ready-to-Eat (RTE) as defined in 9 CFR 430.1.

RTE (Ready-to-Eat) product is 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. RTE 

product is not required to bear safe handling instructions or other labeling that directs that 

the product must be cooked or otherwise treated for safety and can include frozen meat and 

poultry products.

Shelf-Stable (SS) product is free of microorganisms (pathogens and spoilage) capable of 

growing in the product at non-refrigerated conditions at which the product is intended to be held 

during distribution and storage. Shelf-stability is primarily achieved through drying or low water 

activity (aw).

Heat-Treated, Shelf-Stable. This category applies to establishments that further process by 

using a heat treatment processing step as the primary means to achieve food safety, in 

combination with curing, drying, or fermenting processing steps. The finished products are 

shelf-stable and are not required to be frozen or refrigerated for food safety purposes.

Not Heat-Treated, Shelf-Stable. This category applies to establishments that further process 

by curing, drying, or fermenting to achieve food safety. The finished products are shelf-stable 

and not required to be frozen or refrigerated for food safety purposes.
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Cooking is a very important step, because it is here that any pathogens (e.g., Salmonella) 

that may be in the product will be eliminated and the numbers of spoilage bacteria will be 

lowered to an acceptable level. This is called a lethality treatment. The cooling process is 

also known as stabilization.

Shelf-stable dried meat snacks have a low moisture content (22-24%) and low water 

activity. A water activity limit of ≤0.85 should control growth of all bacterial pathogens of 

concern as well as mold for products stored in the presence of oxygen; however, if the 

product is vacuum packaged in an oxygen-impervious packaging (anaerobic environment), 

the water activity limit could be ≤0.91.

Dried Whole Muscle Meat Products

• Mostly dry cured

• Treated with salt or salt brines to achieve shelf stability

• Primary factor affecting shelf stability is aw

• Examples include:

• Dry hams (Prosciutto, Parma, Country Ham)

• Dry pork shoulders (Coppa)

• Dry pork bellies (Pancetta)

• Dry beef rounds (Bresaola, Beef Prosciutto, Basturma)

Dry and Semi-Dry Sausages

• Probably the largest group of dried products

• Further broken down into:

• Fermented products (acidified by adding a starter culture of acid producing 

bacteria to the product) such as pepperoni, hard salami, and summer sausage

• Acidified with chemical acidulants (faster process than fermentation) such as 

meat sticks made without starter culture

• Non-acidified cooked products such as formed and extruded jerky products, or 

cooked and dried salami for export to Japan

Establishments can apply the multiple hurdles concept, which uses a combination of 

critical operational parameters to achieve lethality (i.e., multiple steps to kill pathogens) to 

control a food safety hazard. Examples of multiple hurdles include the combination of 

high salt content and drying in the dry-cured ham process, and the combination of 

fermentation (increased acidity to control Staphylococcus aureus), cooking or smoking 

(optional), and drying in the fermented, dry sausage process (controls multiple pathogens 

including Clostridium botulinum and Clostridium perfringens). Drying in the fermented, 

dry sausage process is also important because it helps the products meet their standard 

of identity and controls the outgrowth of Clostridium botulinum and Clostridium 

perfringens so that drying achieves stabilization and the cooling step is unnecessary.
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25 Lethality and Stabilization

Objectives:

1. Define: Lethality, Stabilization, Performance Standard, Target, Critical Operating Parameter, and 

Scientific Gap.

2. State regulatory lethality and stabilization performance standards.

3. Identify compliance guidelines frequently used to support lethality, stabilization, and multiple 

hurdles processes.

4. Identify critical operational parameters in the FSIS guideline for lethality.

5. Describe the relationship between humidity and cooking.

6. Identify which microorganisms are controlled in the lethality and stabilization steps.

7. Explain the food safety significance of drying in the jerky process.

8. Explain how multiple hurdles are used in a food safety system.

9. Describe how inspectors verify that establishments have support for their lethality, stabilization 

and multiple hurdle processes.

Ready-to-Eat (RTE) products are meat or poultry products that are edible without additional 

preparation to achieve food safety. Two main processes which are critical for achieving safety in 

RTE products are known as lethality and stabilization. They are used to control the biological hazards 

in RTE products.

Lethality (cooking) is defined as the process or steps used to destroy pathogenic microorganisms 

in a product to make the product safe for human consumption.

After the product is cooked, spores of Clostridium botulinum and C. perfringens that survive the 

cooking process can germinate, becoming vegetative cells that can multiply to hazardous levels if 

cooling is inadequate. Rapid cooling from 130°F to 80°F is necessary to prevent the growth of 

Clostridium bacteria. The processes that establishments employ to limit the growth of spore-forming 

bacteria are called stabilization (cooling).

The most common stabilization is cooling. However, other treatments, such as lowering the product 

pH through fermentation or marination, prevents the growth of Staphylococcus aureus. Drying or 

salt-curing to reduce the water activity or adding antimicrobials may also be used in combination with 

heating or each other to destroy pathogens. The use of multiple treatments to achieve lethality or 

stabilization is called the multiple hurdle concept.

For certain RTE products, FSIS has established regulatory performance standards because they 

have a higher public health risk. These products have historically been associated with foodborne 

illnesses caused by specific pathogenic bacteria or their toxins (Salmonella, L. monocytogenes, E. 

coli O157:H7, C. perfringens, and C. botulinum).
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RTE products are adulterated if they contain pathogens of public health concern, or their toxins:

o Any Salmonella, Lm, or STEC is injurious to health.

o Any C. botulinum growth is a public health concern.

o C. perfringens at levels that could lead to toxin formation indicates product was prepared, 

packed or held under insanitary conditions.

Performance standards are quantifiable pathogen reduction levels or growth limit requirements set 

by FSIS for lethality and stabilization of certain products.

Lethality performance standards require establishments to ensure the lethality process for certain 

RTE products meets a specific log-10 reduction of Salmonella microorganisms. The lethality 

performance standard requires a minimum 6.5-log reduction of Salmonella for roast beef, cooked 

beef, and corned beef, at least a 7.0-log reduction of Salmonella in cooked poultry products, and 

cooked uncured meat patties to achieve a 5-log reduction of Salmonella (and other pathogens 

including STEC).

The stabilization performance standards are quantifiable pathogen growth limit requirements set 

by FSIS for the stabilization of certain meat and poultry products. The stabilization performance 

standard requires: No multiplication of C. botulinum and no more than 1-log increase of C. 

perfringens throughout the product shelf life.

Establishments may use alternative lethality or stabilization support for certain products. The 

establishment must be able to demonstrate that the alternative support achieves a different (usually 

lower) log reduction than what is prescribed in the regulations.

Targets are quantifiable pathogen reduction levels or growth limits set by the establishment to 

produce safe products in the absence of regulatory performance standards. Salmonella is used as a 

target organism because death of Salmonella indicates destruction of other vegetative pathogens.

Critical operating parameters are the time-temperature intervention combinations establishments 

apply to cooked products that affect pathogen log-10 reductions and achieve lethality. Critical 

operating parameters may include but are not limited to time, temperature, water activity, 

concentration, relative humidity, and even type of equipment necessary to achieve the critical 

operating parameter.

FSIS Compliance Guidelines provide guidance to industry and may be used to support CCPs and 

critical limits in a HACCP plan. It is not mandatory for the establishment to use these guidelines. For 

example, Appendix A provides support for lethality (time, temperature, and humidity for cooking 

processes) and Appendix B for stabilization (cooling options). These Compliance Guidelines do not 

cover catfish, pork rinds, lard and tallow, dried products, partially heat treated not ready-to-eat 

products, or the production of products that rely on multiple hurdles to achieve lethality and shelfstability. The Jerky Guideline describes requirements for lethality (heat and humidity) prior to drying.
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FSIS time-temperature tables identify relative humidity as a critical operating parameter to ensure 

moist cooking and adequate surface lethality of pathogens, especially Salmonella. Unless the 

establishment can provide additional support for why humidity would not be needed in its process to 

ensure lethality on the product surface, there is a concern in not maintaining humidity because:

o Product surfaces will take longer to heat.

o Product surfaces can dry out.

o Bacteria can become more heat resistant.

Appendix A and Appendix B have identified Scientific Gaps in several common cooking processes 

where adequate support for achieving critical operating parameters is lacking. Until scientific research 

becomes readily available, establishments may address scientific gaps by referring to 

recommendations from older FSIS cooking guidance for:

• Products cooked for short times at high temperatures.

• Products cooked using cooking methods, such as microwaves, that are not designed to control 

relative humidity.

• Other processes that may inherently maintain relative humidity around the meat and poultry 

filling but cannot follow one of the relative humidity options.

• Processes where the drying step comes before cooking under moist conditions.

• Products with long heating come-up-times (CUT).

• Partially heat-treated, smoked, not fully cooked products containing nitrite and either erythorbate 

or ascorbate that cannot follow the new cooling options due to long heating come-up and cooling 

times.

• Large mass, non-intact, fully cooked products, including scalded offal that cannot cool quickly 

enough to follow the new cooling options.

• Fully cooked, smoked bacon containing nitrite and erythorbate/ascorbate that achieve the lethal 

time and temperature combinations but cannot use the new cooking options because relative 

humidity is not addressed.

• Immersion or dry-cured products containing nitrite that use equilibration time instead of 

erythorbate or ascorbate but cannot meet cooling options without nitrite.

• Products that contain nitrite and use equilibration time instead of erythorbate or ascorbate, but do

not have a brine concentration of ≥ 6%.
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26 Food Ingredients of Public Health Concern

Objectives:

1. List the “Big 9” allergens.

2. Distinguish between a food allergy and a food intolerance.

3. List examples of food ingredients to which some individuals are intolerant.

4. Describe establishment responsibilities for controlling ingredients of public health concern.

5. Identify situations that may lead to cross-contact with a food allergen.

6. Identify situations that may result in mislabeling of a product containing an ingredient of public health 

concern.

7. Distinguish between labeling requirements for ingredients of public health concern and voluntary 

labeling declarations.

8. Describe when an establishment can include factual statements about the processing environment on a 

finished product label.

9. Perform and document the “Big 9” Formulation Verification Task.

10. Identify additional labeling concerns that require a directed General Labeling Task & documentation of 

general labeling noncompliance.

Introduction

FSIS is responsible for verifying that establishments have adequate in-plant ingredient controls and 

appropriate product labeling that lists ingredients in descending order of predominance by common or 

usual name.

Food Allergies

Exposure to specific proteins in certain food ingredients, not a direct harmful effect from the 

ingredient itself, can trigger a severe immune system reaction in individuals with food allergies. 

An allergic reaction is a hypersensitive, aggressive immune system response with symptoms 

that include tingling in the mouth, tongue and throat swelling, breathing difficulty, hives, 

vomiting, abdominal cramps, diarrhea, drop in blood pressure, and unconsciousness. In severe 

cases, life-threatening allergic responses called “anaphylactic reactions” may result in death. No 

conclusive scientific evidence exists that defines a necessary minimum threshold level for a food 

allergen to cause an adverse reaction. In most cases, the presence of an undeclared substance 

that is a known allergen, even in trace amounts, poses a significant public health risk and a 

potentially catastrophic allergic reaction in an allergic individual.
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The FDA has identified nine foods (“Big 9”) and any ingredients that contain protein derived 

from these nine foods as major food allergens. The foods that account for approximately 90% of 

food allergies are:

• Milk

• Eggs

• Fish (e.g., bass, cod, or flounder)

• Crustacean shellfish (e.g., crab, lobster, or shrimp)

• Tree nuts (e.g., almonds, pecans, or walnuts)

• Peanuts

• Wheat

• Soybeans

• Sesame

NOTE: Attachment 1 in FSIS Directive 7230.1 provides a comprehensive list of ingredients and 

products that may be derived from the “Big 9” food allergens.

According to FDA estimates, food allergies result in 30,000 emergency room visits, 2,000 

hospitalizations, and 150 deaths each year. While these reactions can be treated, there is no 

cure for food allergies. To avoid consequences, consumers with a food allergy rely on accurate 

labeling of food products to strictly avoid foods containing the allergen.

Food Intolerances

Some individuals may be intolerant of certain food and color additives. The adverse effects of 

food intolerances, which are often confused with allergic reactions, are generally not lifethreatening and do not involve the same immunological mechanisms. Nevertheless, they can 

have significant public health consequences.

Lactose is a sugar molecule in milk and milk product derivatives. Some people are deficient in 

lactase, an enzyme in the intestinal tract that breaks down lactose. People with lactose 

intolerance experience gas, bloating, cramping, and sometimes diarrhea.

Sulfites are added ingredients used as to preserve food and prevent browning of processed 

fruits, vegetables, and shellfish. People with sulfite intolerance can experience chest tightness, 

hives, stomach cramps, diarrhea, breathing problems, and an increased risk of having asthma 
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symptoms for sensitive people with asthma.
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FD&C Yellow No. 5, a color additive also known as tartrazine, is used in a variety of food 

products. Tartrazine can cause symptoms similar to an allergic reaction (i.e., hives and swelling) 

in intolerant consumers.

Monosodium Glutamate (MSG) is added to a number of meat and poultry products as a flavor 

enhancer. Some individuals report headache, chest tightness, nausea, diarrhea, and sweating 

following consumption of MSG-containing products.

Gluten is the protein found in cereal grains (e.g., barley, rye, oats) that helps give dough its 

elasticity. Individuals who are intolerant to gluten have a condition known as celiac disease. 

Symptoms may include fatigue, bloating, cramping, chronic diarrhea, nutrient malabsorption, 

and, although not an allergic reaction, inflammation and damage to the lining of the small 

intestine.

Nitrate and nitrites are different nitrogenous compounds used as curing agents in many meat 

and poultry products (e.g., hotdogs, bologna, salami, other processed meats) to inhibit the 

growth of Clostridium spp. and contribute to the characteristic flavor and color of cured 

products. Consuming nitrate or nitrite compounds may cause headache and hives in some 

people. The amount of nitrite or nitrate added to a product is restricted by regulation because 

excessive concentrations can be toxic.

Some product formulations include only naturally occurring sources of nitrite or nitrate (e.g., 

celery juice powder, parsley, cherry powder, beet powder, spinach, sea salt) and must be 

labeled appropriately (e.g., “uncured” bacon product that includes a declaration on the product 

label stating, “Uncured Bacon, No Nitrates or Nitrites added except those naturally occurring 

in ") because naturally occurring sources of nitrite or nitrate do not inhibit the 

outgrowth of Clostridium spp. as well as the highly purified chemical forms. In addition, cured 

products generally bear a statement such as "Not Preserved, Keep Refrigerated Below 40°F 

at All Times." Exceptions to the refrigeration handling statement include finished products that 

have been sufficiently dried according to other requirements or contain an amount of salt 

sufficient to achieve an internal brine concentration of ≥10%.

NOTE: FD&C coloring agents (e.g., Red No. 3 and Red No. 40 added to cures as a tint to 

distinguish nitrite-containing compounds from salt) do not need to be declared on the product 

label since their use is considered incidental and does not function as a color additive in the 

meat or poultry product. Similarly, release agents used on grills, loaf pans, cutters, or other hard 

production surfaces are generally considered to be a processing aid and their incidental use is 

not required to be declared on the product label.
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Establishment Responsibilities

The establishment is responsible for researching all ingredients used in its product formulations 

and determining if an ingredient may trigger a food allergy. FSIS expects establishments to 

employ appropriate food safety procedures (i.e., HACCP plans, SSOPs, or other prerequisite 

programs) that ensure added ingredients match the product formula and all ingredients are 

properly and accurately disclosed on the product label.

Ongoing sanitary measures must prevent cross-contact between allergenic and non-allergenic 

products, equipment, and utensils, and ensure accurate label declarations on products that 

contain allergens. Cross-contact can be avoided through effective controls and appropriate use 

of ingredients, such as checking ingredient containers at receiving for damage, ensuring proper 

identification and control of allergenic ingredients and products throughout production, effective 

sanitation measures, training employees to work with allergens, and adhering to product 

formulations.

In addition to inadequate sanitary controls, accidental application of inaccurate labels to properly 

formulated products poses a threat to sensitive consumers. The establishment can ensure 

accurate product labeling by changing labels when changing product formulations, reviewing 

incoming non-meat/non-poultry ingredient labels for changes, discarding obsolete labels after a 

change in product formulation, reviewing newly printed labels for accuracy, controlling labels to 

ensure application of the correct label, maintaining adequate identification controls of product 

containing an allergenic ingredient that is intended for rework, and declaring an allergen 

indirectly added to the product.

NOTE: When reviewing an establishment’s hazard analysis and supporting documentation 

regarding the use of highly refined edible oils, be aware that highly refined edible oils (e.g., 

soybean oil, peanut oil) are plant-based oils that have been processed and rendered virtually 

free of allergenic proteins and are safe for the food-allergic population to consume. However, 

allergen-containing products cooked or par-fried in highly refined edible oils may leave traces of 

allergenic proteins behind in the oil. Establishments that reuse the same oil to cook or par-fry 

products should consider the potential hazard oil reuse might pose to food-allergic consumers.

Avoiding cross-contact between products containing a food allergen and those that do not is 

critically important. Cross-contact could result from inadequate control or inappropriate use of 

ingredients of public health concern.
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Situations that may allow for cross-contact to occur include the establishment failing to:

• Check ingredient containers for damage at receiving to prevent allergen contamination 

within the establishment.

• Implement a program to ensure proper identification and control of allergenic 

ingredients, allergen containing products, and allergen containers through receiving, 

weighing, formulation, and packaging.

• Ensure effective sanitation measures are in place to address the potential for crosscontact when producing multiple products with different formulations.

• Implement adequate sanitation procedures for cleaning of utensils and equipment used 

in formulating and processing both products containing an allergen and products without 

allergens.

• Train employees on the appropriate use of ingredients and the need to be especially 

careful when working with allergens.

• Appropriately identify/store products to be reworked that contain an allergen.

• Manufacture a product in accordance with the intended product formulation.

In addition to inadequate controls to prevent cross-contact, accidental application of inaccurate 

labels to properly formulated products could pose a threat to consumers sensitive to any 

ingredients in the formulation. Examples of how inaccurate labeling of a product can occur 

include the establishment failing to:

• Declare ingredients listed in the product formula on the product label by common or usual 

name.

• Change labels when changing over from one product formulation to another.

• Review the labels on incoming non-meat/non-poultry ingredient mixes at receiving for 

changes.

• Discard obsolete labels after a change in product formulation.

• Review newly printed labels to ensure accuracy.

• Control labels for products with similar appearance but different ingredients to ensure 

application of the correct label (e.g., storing mixed bundles of labels for similar products with 

different ingredient formulas which could lead to a mix-up of labels).

• Maintain adequate production controls over a product that contains an allergenic ingredient 

and is intended for rework, allowing it to be reworked into a product not labeled to contain 

that ingredient.
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• Declare an allergen that was indirectly added to the product. An example would be an 

establishment that is producing product on a food contact surface sprayed with a non-stick 

coating (a release agent intended to prevent product from adhering to the food contact 

surface) containing soy lecithin and is not properly declaring the soy lecithin on its finished 

product label. Note that substances used as release agents on surfaces, including grills, loaf 

pans, cutters, or other hard surfaces, are generally considered to be processing aids and 

are not required to be declared in the ingredients statement on the meat or poultry product 

label. However, if a particular release agent contains a known allergen, such as soy lecithin, 

official establishments must list the allergenic ingredient in the ingredients statement on the 

product label. Many cooking sprays (e.g., PAM®) used as release agents will contain soy 

lecithin as an emulsifier. Some may contain other allergenic ingredients as well.

Label Declarations

Under FMIA and PPIA, all ingredients used to formulate meat or poultry products generally 

must be declared by its common or usual name in the ingredients statement on the 

product label.

With few exceptions, a meat or poultry product is considered to be misbranded if it 

contains permitted ingredients that are not declared on product labels.

The need for accurate, informative product labeling is especially important for individuals with 

allergies or food intolerances. FSIS supports the use of voluntary statements on labels to further 

alert people with sensitivities or intolerances to the presence of specific ingredients (e.g., a label 

statement such as, “Contains: milk, wheat gluten” or a product label specifying, “Contains 

sodium caseinate (from milk)” to alert milk allergic consumers that an ingredient contains or is 

derived from milk).

On a limited case-by-case basis, the FSIS Labeling and Program Delivery Staff (LPDS) may 

permit the use of factual labeling statements about a product’s manufacturing environment. 

However, the Agency does not consider the casual use of an elective statement about a 

product’s manufacturing environment as helpful to consumers and does not promote good 

manufacturing practices under a HACCP system.
184

Factual Labeling Statements

With the exception of ingredients consistent with the FDA’s definition of a processing aid or 

incidental additive, all ingredients listed on labels of incoming food and food ingredients must be 

declared on finished product containers. Official establishments must list an allergenic 

ingredient in the product label ingredients statement if a formulation component used contains a 

known allergen (e.g., soy lecithin in a release agent). All ingredients listed in a “may contain” or 

“produced in a facility” statement must be listed on the final label unless the establishment has

(1) contacted the supplier and confirmed, preferably in writing, that the statement is a 

cautionary statement, and no such ingredient is in the product; and (2) included a written 

statement in its hazard analysis supporting why the “may contain” or “produced in a facility” 

statement is not documented on the finished meat or poultry product label.

FSIS will consider any non-misleading symbols, statements, or logos to inform consumers of the 

presence of ingredients of public health concern in meat or poultry products. An establishment 

may submit such a request to the Agency as a policy inquiry but not as label-approval 

submission.

NOTE: Some chemicals mentioned in this handout may be classified as “generally recognized 

as safe” (GRAS) for human consumption. Although this module focuses on the addition of 

ingredients reported to cause adverse health effects in some individuals, establishments must 

consider all potential chemical food safety hazards, including ingredients that are GRAS, in their 

hazard analyses.

Factual Labeling Statement Example:

An official establishment uses chopped peanuts in making a dry, Thai-style meat sauce mix. 

The processing environment must remain dry during operations. Since the production 

equipment cannot be washed, peanut dust may become airborne and unavoidably contaminate 

other meat or poultry products manufactured in the same production area. In such situations, a 

statement about the manufacturing environment as described above or the use of a “may 

contain (name of allergenic ingredient)” statement has been approved by LPDS. However, it is 

not acceptable to use this type of statement to address poor SSOPs, such as potential crosscontamination between different products due to inadequate equipment wash between 

production.
185

Inspection Program Personnel Responsibilities

Establishments are expected to have effective controls and preventive measures to address all 

potential chemical hazards, including food allergens and other ingredients of public health 

concern. IPP will verify that the establishment addressed allergens as a potential chemical food 

hazard in its hazard analysis, has support for decisions made in its hazard analysis, and 

implemented effective controls based on those decisions.

IPP must be up to date and aware of the establishment’s controls and preventive measures for 

allergens and ingredients of public health concern. Multiple inspection activities (e.g., HAV task, 

HACCP Verification task, Review of Establishment Testing Data task, Pre-operational and 

Operational SSOP tasks, General Labeling Task, and “Big 9” Formulation Verification task) may 

be necessary to verify that an establishment’s food safety system meets regulatory 

requirements for allergens and ingredients of public health concern. IPP will issue an NR under 

the appropriate inspection task if the establishment:

• Fails to address a potential chemical food safety hazard in its process.

• Does not have adequate documentation on file to support decisions made in its hazard 

analysis for hazards that are not reasonably likely to occur.

• Fails to adequately implement its SSOPs or other prerequisite programs to support a 

decision that a chemical food safety hazard is not reasonably likely to occur.

• Fails to appropriately declare any allergen or other ingredient of public health concern on the 

product label.

“Big 9” Formulation Verification Task

The “Big 9” Formulation Verification task provides IPP with a method for verifying that 

establishments are accurately controlling and labeling the nine most common food allergens. 

Performing the task as described in FSIS Directive 7230.1 includes reviewing records, 

observing production processes, and responding to specific task-related questions in PHIS.

IPP assigned to establishments that produce products in any of the HACCP processing 

categories other than slaughter must determine whether the establishment produces any 

products that may contain any of the “Big 9” food allergens. Review the preventive and control 

measures developed by the establishment to verify that such measures are being effectively 

implemented and product label ingredients are consistent with product formulation records.
186

Depending on its processes and decisions made in its hazard analysis, an establishment’s 

preventive and control measures to control allergens may be in its HACCP plan, Sanitation 

SOPs, or a prerequisite program.

For establishments in which the “Big 9” Formulation Verification task is relevant, the task will 

appear monthly as a routine Priority 3 task on the Establishment Task List in PHIS. IPP will 

perform the routine verification task on each shift in establishments with multiple shifts. In 

establishments that produce more than one product, IPP are to use the chart from Directive 

7230.1 (page 5) to prioritize product selection. Whether or not the establishment produces

products containing a “Big 9” allergen, IPP are to apply the priority list to all products in an

eligible establishment.

NOTE: Examples of multi-ingredient components include sauces, condiments (e.g., ketchup, 

mustard), seasoning packets, flavorings, spice mixes, soup bases, or other combinations of two 

or more ingredients mixed together. Additional considerations regarding multi-ingredient 

seasonings or spices, processing aids, incidental additives, release agents, and “may contain” 

or “produced in a facility” statements on incoming food and food ingredients are outlined in FSIS 

Directive 7230.1.

To perform a routine “Big 9” Formulation Verification task, IPP must first schedule the task in 

advance and determine which products will be produced on that date. Next, they must select a 

product for the task, which may require coordinating with IPP on other shifts to avoid selecting 

the same product for consecutive tasks. Always attempt to select products that have not been 

selected previously unless there has been a change in supplier, ingredients, formulation, or the 

establishment produces a very limited number of products.

NOTE: If FSIS Directive 7230.1 task criteria does not apply to the operation, IPP are to find the 

“Big 9” Formulation Verification task on the Establishment Profile/Inspection Tasks page for the 

establishment and disable the task in accordance with FSIS Directive 13,000.1.

After selecting a product, IPP are to obtain that product’s specific product formulation from the 

establishment for verification in accordance with 9 CFR 318.6 and 9 CFR 381.180. The “Big 9” 

Formulation Verification task may be performed using a combination of the recordkeeping and 

review and observation inspection components.
187

Performing the task involves:

1. Reviewing product formulation records and observing product formulation process steps 

to verify that all ingredients used in the production of the product are consistent with the 

intended product formulation.

2. Reviewing the product label to verify that all ingredients used in formulating the product 

are declared in the ingredients statement by common or usual name and in descending 

order of predominance.

3. Observing that the appropriate label is applied to the product.

4. Observing that the applied label is consistent with the establishment’s label approval on 

file.

As part of documenting the task in PHIS, IPP will respond to specific questions related to this 

task located on the “additional info” tab of the task documentation page. Attachment 2 of FSIS 

Directive 7230.1 provides more information regarding these questions.

If there are any indications of increased risk of undeclared allergens in the establishment, the 

“Big 9” Formulation Verification task may be performed more frequently as a “for cause” directed 

task. Before scheduling additional “Big 9” Formulation Verification tasks, IPP should discuss 

with their supervisor the circumstances and any concerns of increased risk of undeclared 

allergens.

Documenting Noncompliance with the “Big 9” Formulation Verification Task

IPP are to document noncompliance on an NR in PHIS under the “Big 9” Formulation 

Verification task whenever they determine that a meat or poultry product contains a “Big 9” 

allergen not declared in the ingredients statement on the product label. IPP will cite the relevant 

safety regulation(s) in 9 CFR 317.2(f) for products bearing the meat inspection legend or 9 CFR

381.118 for products bearing the poultry inspection legend. In addition, IPP must always notify 

their supervisor when they identify such noncompliance so that a recall request determination 

can be made.

The establishment’s food safety system has failed anytime it ships product containing an 

undeclared allergen in commerce.

NOTE: If IPP identify concerns when performing the “Big 9” Formulation Verification task and 

believe a directed HAV task should be performed, they are to discuss those concerns with their 

supervisor.
188

Documenting Noncompliance for Other Undeclared Ingredients

If IPP determine that a product contains an ingredient not declared in the ingredients statement 

but it is not a “Big 9” allergen, a directed General Labeling task should be scheduled to 

document General Labeling noncompliance with 9 CFR 317.2(f) for products bearing the meat 

inspection legend or 9 CFR 381.118 for products bearing the poultry inspection legend.

Other Actions

IPP may need to take regulatory control of product at the official establishment as necessary 

to prevent the product from entering commerce. IPP should always contact the FLS for 

guidance any time they have reason to believe any product bearing labels that fail to declare 

one of the “Big 9” food allergens or any other ingredient of public health concern has entered 

commerce. An immediate withholding action on the process may be necessary and a product 

recall may be requested by the Recall Management and Technical Analysis Division 

(RMTAD). Refer to FSIS Directive 8080.1 for more information on recalls.
189

Storage 

Packaging 

Materials

Peeling

Stuffing

Rework

Storage 

Non-meat 

Ingredients

Metal Detector

Receiving 

Raw Meat

Receiving 

Non-meat 

Ingredients

Receiving 

Packaging 

Materials

Storage 

Raw Meat 

andRework

Finished Product Storage

Shipping

27 RTE-SS Hazards and Controls Workshop 

Hotdog Flow Diagram

Weighing 

Non-meat 

Ingredients

Weighing & 

Pre-grinding 

RawMeat and 

Rework

No returned product accepted. 

(Training Example Only)
190

Hotdog - Hazard Analysis – ...EXCERPT... (Training Example Only)

Process 

Step

Potential Food Safety Hazard RLTO Basis If RLTO, What Control Measures? Is this Step a CCP?

Receiving -

raw meat

B-Pathogen growth No TemperatureControl 

Program

ReceivingInspection 

Program

Vegetative pathogens and Trichinae eliminated at 

the Cooking CCP

No

Salmonella, STECs, 

Campylobacter, Trichinella 

spiralis

Yes

Clostridia growth and toxin formation prevented

with Chilling CCP and Temperature Control 

Program

Clostridium botulinum and 

Clostridium perfringens 

(Clostridia)

Yes

C-None

P-Metal, rubber, plastic, wood in 

incoming raw product

No

... ... ... ... ... ...

Cooking & 

Smoking

B-Pathogens and parasites

C-None 

P-None

Yes Cooking at temperatures sufficient to eliminate 

pathogens and parasites

Yes-1B

Cooling B-Clostridium growth

B-Contamination with Lm and 

potential subsequent growth

C-None 

P-None

Yes

No Brine SOP for salt 

concentration, temperature, 

and microbial testing for 

Listeria spp.

Rapid cooling to ensure no growth of C. 

botulinum & 

less than one log growth of C. perfringens

Yes-2B

... ... ... ... ... ...
191

Hotdog HACCP Plan (Training Example Only)

CCP Critical Limits Monitoring 

Procedures

Verification Procedures Records Corrective Actions

1B

Cooking

Internal 

temp at 

least 160°F

Every 2 hours, internal 

temperature checked by 

floor supervisor using 

handheld digital 

thermometer, two temps 

taken from each (upper 

and lower) chain of 

continuous 

cooker/smoker/cooler unit 

checked at specified 

access point “B”

Accuracy of all thermometer s 

checked prior to each shift

Once per shift QC will 

observe one internal 

temp monitoring 

procedure

Daily, QC supervisor will 

review monitoring records and 

other records required by 

417.5(a)(3)

Cooking log 

Thermometer log 

Corrective Actions 

log

QC will take Corrective 

Actions per 417.3

2B

Cooling

Cooler brine 

medium kept 

at or

below 28°F.

Every 2 hours cooler 

brine medium checked 

at specified

access point “A”

Accuracy of all thermometers 

checked prior to each shift

Cooling log 

Thermometer log

QC will take 

CorrectiveActions 

per 417.3

Chain speed 

not to exceed 

100 racks per 

minute.

Every 2 hours chain 

speed checked

Once per shift QC will 

observe one internal temp 

monitoring, one brine temp 

check, and one chain speed 

check procedure

Corrective Actions log

Internal temp 

reduced from 

130°Fto less 

than 40°F in90 

minutes or less

Every 2 hours internal 

product temperature at 

exit checked using 

handheld digital 

thermometer, two temps 

taken from each (upper 

and lower) chain of 

continuous 

cooker/smoker/cooler

Daily, QC supervisor will 

review monitoring records and 

other records required by 

417.5(a)(3)

All three monitoring checks 

done by floor supervisor
192

28 Ready-to-Eat (RTE) Sanitation

Objectives

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.

Ready-to-eat product - As per 9 CFR 430.1 definitions, a meat or poultry product that is 

edible without additional preparation to achieve food safety and may receive additional 

preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes. RTE 

product is not required to bear safe-handling instructions (as required for non-RTE products by 

9 CFR 317.2(i) and 381.125(b) or other labeling that directs that the product must be cooked or 

otherwise treated for safety and can include frozen meat and poultry products.

Post-lethality Treatment - A process that eliminates or reduces levels of Listeria 

monocytogenes on or in an RTE product to make it safe for human consumption. Examples of 

post-lethality treatments are cooking and high-pressure processing (HPP). The application of 

an antimicrobial agent (e.g., potassium lactate; sodium diacetate) or an antimicrobial 

process (e.g., freezing; low water activity or pH) that limits or suppresses L. monocytogenes 

growth may also be used as a post-lethality treatment if it eliminates or reduces L. 

monocytogenes growth over the shelf life of the RTE product.

Post-lethality exposure - Exposure of product that has been subjected to an initial lethality 

treatment to the environment in the processing area as a result of slicing, peeling, re-bagging, 

cooling semi-permeable encased product with a brine solution, or other procedures.

Cross-contamination - The transfer of bacteria, possibly including pathogenic bacteria, to the 

exposed RTE product after the lethality treatment. These bacteria can come from the 

environment, from the employees, or from the equipment. They can be transferred directly, 

such as when an exposed RTE product is placed on a tabletop that has bacteria on it. Often, 

they are transferred indirectly, such as when a pallet placed on the floor in a raw area is 

subsequently used in the RTE area, or when an employee handles a pallet and then touches 

exposed product.

Consumed as packaged - Product eaten or consumed as it comes from the package (no 

heating/cooking/mixing/etc.).
193

Many RTE processes involve handling the product after it has been subjected to an initial 

lethality treatment (post-lethality exposure). When the product is directly exposed to the 

environment, it can become cross-contaminated. Cross-contamination is the transfer of 

bacteria, possibly including pathogenic bacteria, to the exposed RTE product after the 

lethality treatment.

Some RTE products may be reheated by the consumer to enhance palatability, but a reheating 

process will not necessarily eliminate any pathogens that exist on or in the product. Because 

many RTE products are consumed right from the package or minimal reheating, any 

pathogens that are present will be consumed along with the product. Thus, there is an 

increased risk of these products causing foodborne illness, and establishments producing 

these products have an increased responsibility for sanitation of the RTE processing 

environment. Sanitation is critical for ensuring that RTE products do not become crosscontaminated. Sanitation SOPs should be established to provide effective and consistent 

results.

Establishments are responsible for producing product that is free from any pathogen. 

The pathogen Listeria monocytogenes (Lm) is the species of Listeria bacteria of particular 

concern because it has potentially fatal consequences. Lm is a biological food safety hazard 

that an establishment producing post-lethality exposed RTE products must control through its 

HACCP plan or prevent in the processing environment through Sanitation SOPs or some other 

prerequisite program. RTE product is considered adulterated if it contains Lm or if it comes into 

direct contact with a food contact surface that is contaminated with Lm.

Lm is spread very easily by direct contact with a contaminated surface. Lm can survive and 

grow in cool, damp environments, such as those found in processing areas, coolers, or 

floors. Incomplete removal of product debris can provide nutrients and a place of attachment 

which allows bacterial growth. Maintaining dry processing equipment will help reduce the 

growth of Lm.

Lm can form biofilms on solid surfaces, such as stainless steel and rubber, and can survive 

adverse conditions on apparently smooth surfaces. Biofilm is a thin, slimy film of bacteria that 

adheres to a surface effectively protecting it from the environment. Biofilms protect the bacteria 

embedded in the biofilm from sanitizers. Rotating detergents and sanitizers help maintain 

effectiveness and keeps bacteria from building resistance. Sanitizing is done after cleaning, 

because a sanitizer cannot work effectively unless the equipment is cleaned first.
194

Lm contamination has been linked to disruptive construction. Lm is in the environment and the 

dust/debris generated during construction can carry it to many different places if not controlled. 

Dust generated by construction and other disruptive activities can establish contamination on 

food contact and other environmental surfaces.

Sanitation is critical for ensuring that RTE products do not become cross-contaminated. 

Sanitation SOPs should be established to provide effective and consistent results. Effective 

sanitation is a complex process. A successful establishment must understand and apply the 

cleaning and sanitizing process and select the proper methodology and chemical agents for 

the particular environment and equipment being cleaned. Typically, effective preoperational 

sanitation can be distilled down to the following recommended steps:

a) Perform dry cleaning of the equipment, floors, conveyor belts, and tables to remove 

meat particles and other solid debris. Some equipment, such as slicers and dicers, may 

require disassembly so that parts can be adequately cleaned.

b) Wash and rinse floor.

c) Pre-rinse equipment (rinse in same direction as product flow). Pre-rinse with warm or 

cold water – less than 140°F (hot water may coagulate proteins or “set soils”).

d) Clean, foam, and scrub equipment. Always use at least the minimum contact time for 

the detergent/foam. Instructions should be provided on identifying possible niches and 

use of appropriate cleaning methods. Live steam for cleaning is not acceptable at this 

step since it may bake organic matter on the equipment.

e) Rinse equipment (rinse in same direction as product flow).

f) Visually inspect equipment to identify minute pieces of meat and biological residues.

g) Sanitize floor and then equipment to avoid contaminating equipment with aerosols from 

floor cleaning. Care should be taken in using high pressure hoses in cleaning the floor 

so that water won’t splash on the already cleaned equipment. Use hot water, at least 

180°F, for about 10 seconds to sanitize equipment. Sanitizers (e.g., acidic quaternary 

ammonia) may be more effective than steam for Lm control.

h) Rotate sanitizers periodically. Alternating between alkaline-based and acid-based 

detergents helps to avoid “soapstone” and biofilms. This also helps change the pH to 

prevent adaptation of bacteria to a particular environment.

i) Dry. Removing excess moisture can be done most safely and efficiently by air drying. 

Reduced relative humidity can speed the process. Avoid any possible crosscontamination from aerosol or splash if a method other than air drying (e.g., using a 

squeegee or towel) is used.
195

Cleaning and sanitizing are very important. Pathogens can be transferred to RTE products 

from equipment and employee hands that have not been adequately cleaned and sanitized. 

Lm can hide in poorly accessible areas of equipment, and it may take several hours of 

production before it has seeded onto direct product contact surfaces of equipment sufficiently 

to become detectable on the product contact surface or the product itself.
196

29 Listeria monocytogenes (Lm) Regulations

Objectives

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 “Listeria Rule Verification Activities.”

Introduction

Listeria monocytogenes (Lm) is a widespread pathogen capable of surviving under various 

environmental conditions. It has been isolated from the soil, plant materials, animal feedstuffs, 

the intestinal tract of various mammals and birds, and has also been found in some species of 

fish and shellfish. Lm is very tolerant of freezing, drying, salt, and heat, and can grow at 

temperatures from 31.3°F up to 113°F. It can adapt to significant changes in pH values and 

reproduce at a pH range between 4.39 and 9.4. Lm can also reproduce with a water activity 

(aw) as low as 0.92.

Listeriosis, a disease caused by consuming food products contaminated with Lm, can occur 

from a few days up to six weeks after ingestion. The infective dose of Lm is believed to be 

fewer than 1,000 organisms. Lm is especially pathogenic to high risk populations, including 

pregnant women and their fetuses, young children, the elderly, and immunocompromised 

individuals. An individual with a mild Lm infection may have general flu-like symptoms, 

including nausea, vomiting, and diarrhea. However, severe infections can lead to septicemia, 

meningitis, encephalitis, and death. Infections during pregnancy may result in a miscarriage or 

stillbirth.

A common link in Lm outbreaks is contamination of RTE products in the post-lethality 

environment prior to packaging. Lm can contaminate a food processing environment from 

animals, ingredients, equipment, personnel, environmental reservoirs, or other means. Once 

Lm contaminates the processing environment, it can establish in drains, on processing 

equipment, and in refrigeration units. The organism can also form a durable biofilm.

Lm may cross-contaminate RTE product exposed to the post-lethality environment due to 

inadequate sanitary practices. Dust, movement of personnel, and equipment associated with 

construction projects (e.g., air handling system repairs, removal of walls, repairs to plumbing 

systems) create opportunities for Lm to cross-contaminate post-lethality exposed product. An 

establishment may need to implement additional sanitation practices and containment 

procedures for any construction projects in or around processing areas where post-lethality 

exposed products are handled and packaged.
197

FSIS considers Lm to be a significant foodborne pathogen of great potential public health 

concern that must be controlled by establishments producing post-lethality exposed RTE 

products. FSIS has developed regulatory requirements specifically for controlling Lm in postlethality exposed RTE products. In addition, the agency has developed Lm sampling programs 

as part of its public health strategy for protecting consumers against Lm. 

Listeria Rule

On June 6, 2003, FSIS published an interim final i.e., 9 CFR Part 430 “Listeria Rule” that 

requires establishments producing post-lethality exposed RTE products to prevent adulteration 

by Lm. 9CFR 430.4(a) identifies Lm as a hazard that establishments producing RTE products 

exposed to the post-lethality environment must control through a HACCP plan or prevent in the 

processing environment through an SSOP or other prerequisite program. It states that RTE 

product is adulterated if it contains Lm or comes into direct contact with a food contact surface 

contaminated with Lm. 9 CFR 430.4(b) identifies three alternatives that establishments are to 

choose from in order to control Listeria in post-lethality exposed RTE product. IPP are 

responsible for using appropriate HACCP or SSOP verification tasks to verify establishment 

compliance with §430.4(b).

Definitions

9 CFR 430.1 provides several definitions that are specific to ready-to-eat (RTE) products. 

Two RTE product definitions are deli products and hotdog products. A deli product is an 

RTE meat or poultry product that is typically sliced, either in an official establishment or after 

distribution, and assembled in a sandwich for consumption. A hotdog product is an RTE meat 

or poultry frank, frankfurter, or wiener product with a standard of identity defined in 9 CFR

319.180 and 319.181. A risk assessment performed jointly by FSIS and the FDA indicated that 

on a per serving basis, deli meats and hotdogs (not reheated) posed the greatest risk of illness 

and death from Lm. 

A lethality treatment is the initial process RTE meat and poultry product undergoes to 

eliminate or reduce the number of pathogenic microorganisms on or in a product. Examples of 

lethality treatments that will make an RTE product safe for human consumption include cooking 

or the application of an antimicrobial agent or process that eliminates or reduces pathogenic 

microorganisms.

The post-lethality processing environment is the area in an establishment into which product 

subjected to an initial lethality treatment has been routed. The product may be exposed to the 

environment through slicing, peeling, re-bagging, cooling semi-permeable encased product in a 

brine solution, or other procedures.

Post-lethality exposed product is RTE product that comes into direct contact with a food 

contact surface in the post-lethality processing environment after an initial lethality treatment. 

Only post-lethality exposed RTE products are subject to 9 CFR 430. 
198

The following three terms are associated with the three Listeria control alternatives used to 

control or prevent Lm in an RTE product in the post-lethality environment:

• Post-lethality treatment (PLT) - an additional lethality treatment, following the initial lethality 

treatment, applied to the final product or sealed package of product to reduce or eliminate the 

risk of Lm contamination during post-lethality exposure. Examples of post-lethality treatments 

include steam pasteurization, hot water pasteurization, radiant heating, and high-pressure 

processing (HPP). Some antimicrobial agents may also function as post-lethality treatments.

• Antimicrobial agent - a substance in or added to an RTE product that suppresses or limits 

growth of Lm in the product throughout the shelf life of the product. Examples of antimicrobial 

agents used in RTE products are sodium lactate, potassium lactate, and sodium diacetate. 

FSIS Directive 7120.1 identifies additional antimicrobial agents approved for use in the 

production of RTE meat and poultry products.

• Antimicrobial process - an operation (e.g., freezing) applied to an RTE product that 

suppresses or limits the growth of Lm in the product throughout the shelf life of the product. 

Drying and fermenting are operations that may be applied to a product to make it RTE and 

subsequently suppress or limit the growth of Lm.

Note: The post lethality treatment should demonstrate at least 1-log decrease of Lm before the 

product is released into commerce and the antimicrobial agent or process should demonstrate 

no more than 2-logs growth of Lm over the shelf life of the product.

While not defined in §430.1, indicator organism is defined in 9 CFR 430 as a species of 

bacterium used to determine if the sanitary conditions of food processing equipment, 

production areas, or storage rooms will allow for the presence of pathogenic microorganisms.

Establishment Responsibilities

An establishment that produces post-lethality exposed RTE meat and poultry products must 

maintains its facility in a sanitary manner. The sanitation program must be designed and 

implemented to prevent contamination of food contact surfaces (FCS) and adulteration of RTE 

product with Lm and other pathogens in the post-lethality environment. The establishment must 

conduct a hazard analysis designed to control FCS contamination and adulteration of RTE 

products. Any hazards considered reasonably likely to occur must be included in a HACCP 

plan and the effectiveness of the RTE processes validated. The establishment should 

incorporate procedures for accurately labeling RTE products, including identifying product for

rework. The hazard analysis, HACCP plan, supporting documentation, and prerequisite 

programs should be maintained and made available to FSIS upon request.

Sampling Program

Under §430.4(b)(2)(iii)(A) and (3)(i)(A), establishments that produce post-lethality exposed 

RTE products are required to provide for FCS testing in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Lm or indicator organism.
199

While sampling is not required under Alternative 1 or Alternative 2, Choice 1, FSIS recommends 

the establishment collect from each post-lethality exposed production line a minimum of 2 Lm 

FCS samples per year (every 6 months) under Alternative 1 and a minimum of 4 Lm FCS 

samples per year (quarterly) under Alternative 2, Choice 1. FCS sampling is required for 

Alternative 2, Choice 2 and Alternative 3. The minimum required sampling frequency from each 

post-lethality exposed production line under Alternative 2, Choice 2 is 4 Lm FCS samples per 

year (quarterly) and once per month (monthly) under Alternative 3. For establishments that 

produce RTE deli products and hotdogs under Alternative 3, the minimum FCS sampling 

frequency from each post-lethality exposed production line is monthly in very small 

establishments, every 2 weeks for small establishments, and weekly in large establishments. 9 

CFR 430.4 requires establishments to identify the size, location, and frequency of the FCS sites 

to be sampled and provide an explanation of why the testing frequency is sufficient to ensure 

that Lm will be effectively controlled.

IPP Responsibilities for Verifying Compliance with 9 CFR Part 430.4

In order to verify compliance with 9 CFR 430.4, IPP must be familiar with the establishment’s 

RTE products and processes. If necessary, establishment management should be asked if they 

produce any RTE product that is exposed to the environment following the initial lethality step.

IPP should ask the establishment which of the three Listeria control alternatives was chosen for 

each post-lethality exposed RTE product produced. If necessary, plant management should be 

advised that initial validation results supporting the effectiveness of the selected alternative must 

be made available to FSIS upon request.

IPP should verify that the establishment is meeting the requirements of the alternative it 

selected by performing the appropriate SSOP or HACCP tasks. If the establishment decides to 

produce different products using different alternatives, the inspector should verify that each 

post-lethality exposed RTE product meets the requirements for the alternative selected.

In addition to verifying the effectiveness of the Listeria control alternatives selected, IPP will 

verify that the establishment is maintaining sanitary conditions sufficient to prevent product 

contamination, including Lm. Sanitation is the foundation for controlling Lm and without it, no 

alternative will successfully control Lm. 

Note: See Attachment 1 for L. monocytogenes control requirements and Attachment 2 for 

summaries of the Listeria control alternatives and their requirements.

Alternative 1 - 9 CFR 430.4(b)(1)

Alternative 1 uses a post-lethality treatment (which may also be the antimicrobial agent or 

process) that reduces or eliminates microorganisms on the product AND an antimicrobial agent 

or process that suppresses or limits the growth of Lm. 
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Alternative 1 Compliance Example

While verifying that an establishment is meeting the requirements of 9 CFR 430 and Alternative 

1, you review the establishment’s hazard analysis for sliced semi-dry sausage products (e.g., 

Genoa salami, sandwich pepperoni, etc.). You determine that the fermentation, heating, drying, 

and packaging steps have been identified as CCPs in the hazard analysis and were 

incorporated into a HACCP plan. The hazard analysis and HACCP plan identify lowered acidity 

(pH) through the use of bacterial starter cultures and lowered water activity from drying as 

measures to limit the growth of Lm in the finished product throughout the product’s shelf life. A 

steam pasteurization process after the product has been vacuum packaged was identified as a 

post-lethality treatment to reduce or eliminate Lm contamination. There are critical limits at the 

respective steps for pH, water activity, and time and temperature exposure for the steam 

pasteurization process. You request the supporting documentation for the critical limits and the 

establishment provides scientific literature and the results of challenge studies conducted by a 

processing authority. Supporting documents show that pH and water activity in the product 

allows no more than a 2-log increase of Lm during refrigerated product shelf life and the steam 

pasteurization process is effective in achieving at least a 1-log decrease of Lm. Based upon 

your review, you determine that the establishment is in compliance with 9 CFR 430.4(b)(1).

Alternative 2 - 9 CFR 430.4(b)(2)

Alternative 2 uses either a post-lethality treatment (which may be an antimicrobial agent or 

process) that reduces or eliminates microorganisms on the product or an antimicrobial agent 

or process that suppresses or limits the growth of Lm.

Under Alternative 2, an establishment may select either Choice 1 or Choice 2 as follows.

 Alternative 2, Choice 1 - The establishment uses a post-lethality treatment (which may 

be an antimicrobial agent) that reduces or eliminates Lm on the product.

 Alternative 2, Choice 2 - The establishment uses an antimicrobial agent or process 

that suppresses or limits the growth of Lm.

Alternative 2 Compliance

Example 1: An establishment's product line includes chicken salad and ham salad in 

hermetically seals containers under Alternative 2, Choice 1. The cooked, sealed containers are 

batch loaded into cylinders and the cylinders are loaded into a chamber, to undergo High 

Pressure Processing (HPP) as a post-lethality treatment. You are reviewing the establishment's 

hazard analysis and HACCP plan for these products to verify compliance with the requirements 

for Alternative 2, Choice 1 as specified in 9 CFR 430. In its hazard analysis, the establishment 

concluded that Lm was a hazard reasonably likely to occur (RLTO) in the post-lethality 

processing environment. The establishment identified the HPP as a post-lethality treatment and 

included it in its HACCP plan as a CCP. The critical limit for HPP is time at a specific pressure 

level. In reviewing supporting documents for the CCP, you determine there are other critical 

parameters associated with this type of treatment, including product temperature before high 

pressure processing and water fill level of the pressure chamber. You request additional
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documentation supporting that the establishment achieves these additional critical parameters. 

The establishment provides documents that show the product temperature is consistently 40°F 

or less at the packaging step and that the pressure chamber water level is monitored to ensure 

that the required level of pressure can consistently be achieved in the high pressure process. 

You conclude that the establishment is in compliance with 9 CFR 430.4(b)(2).

Example 2: You are verifying that an establishment is meeting the requirements of §430 and 

Alternative 2, Choice 2. You review the establishment’s hazard analysis for fully cooked frozen 

breaded chicken products and verify that the cooking and chilling steps have been identified as 

CCPs in the hazard analysis and were incorporated into a HACCP plan. In addition to these 

CCPs, Lm was considered a potential hazard not reasonably likely to occur (NRLTO) at the 

packaging step because of the Listeria control measures in the establishment’s SSOP designed 

to prevent Lm in the post-lethality processing environment. You request the supporting 

documentation for decisions made in the hazard analysis and the establishment provides a 

scientific document that identifies freezing as an antimicrobial process that would inhibit Lm 

growth in the finished product throughout the shelf life of the product. The establishment also 

provides the verification procedures and associated records it uses to demonstrate that 

products are frozen below the level that the scientific validation document establishes as 

effective in preventing the growth of Lm. The records for the past several months show that the 

product is achieving the frozen temperature needed to suppress the growth of Lm and is labeled 

with the instructions “Keep Frozen.” You review the establishment’s SSOP and records and 

verify that the establishment is testing food contact surfaces in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Listeria spp. The establishment 

has identified the conditions under which the establishment will implement hold-and-test 

procedures following a positive test of a food contact surface for Listeria spp., the size and 

location of the sample sites, and the testing frequency. It also provided a thought process as to 

why the testing frequency it selected is sufficient to ensure that effective control of Lm is 

maintained. Based upon your review, you determine that the establishment is in compliance 

with 9 CFR 430.4(b)(2).

Alternative 3 - 9 CFR 430.4(b)(3)

Alternative 3 involves the use of sanitation measures alone to prevent Lm in the 

processing environment and on the RTE product. There are separate FCS sampling 

requirements for deli meat and hotdogs produced under this alternative.

Alternative 3 Compliance

Example 1: You are verifying that the establishment is meeting 9 CFR 430 and Alternative 3 

requirements. You review the establishment’s hazard analysis for fully cooked, not shelf stable 

breakfast type products (e.g., bacon, sausage patties, sausage links, etc.). You verify that the 

cooking and chilling steps have been identified as CCPs in the hazard analysis and were 

incorporated into a HACCP plan. Lm was considered a potential hazard NRLTO at the 

packaging step because the establishment has implemented sanitary measures to control Lm 

in the post-lethality processing environment. You request the supporting documentation for the 

decision that Lm is NRLTO in the post-lethality environment. You review the establishment’s
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SSOP program and records. You verify that the establishment is testing food contact surfaces 

in the post-lethality processing environment to ensure that the surfaces are sanitary and free of 

Listeria spp. the establishment has also identified the conditions under which it will implement 

hold-and-test procedures following a positive test of a food contact surface for Listeria spp., the 

size and location of the sample sites, and frequency of testing. The establishment provided a 

thought process documenting why the testing frequency selected is sufficient to ensure that 

effective control of Lm is maintained. Based upon your review, you determine that the 

establishment is in compliance with 9 CFR 430.4(b)(3).

Example 2: You are verifying that the establishment is meeting the requirements of 9 CFR 

430 and Alternative 3. You review the establishment’s hazard analysis for fully cooked, not 

shelf stable deli and hotdog type products (e.g., franks, sliced ham, sliced bologna, sliced roast 

beef, sliced turkey breast, etc.). You verify that the cooking and chilling steps were identified 

as CCPs in the hazard analysis and incorporated into a HACCP plan. The establishment 

considered Lm a food safety hazard NRLTO at the packaging step because of Listeria control 

measures in its SSOP intended to prevent Lm from occurring in the post-lethality processing 

environment. You request the supporting documentation for the decision that Lm is NRLTO in 

the post-lethality environment. You review the establishment’s SSOP and records and verify 

that the establishment is testing food contact surfaces in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Listeria spp. The 

establishment has identified the conditions under which it will implement hold-and-test 

procedures following a positive test of a food-contact surface for Listeria spp., the size and 

location of the sample sites, and the testing frequency. It also provided a thought process 

documenting why the testing frequency selected is sufficient to ensure that effective control of 

Lm is maintained.

You determine that the establishment verifies the effectiveness of the corrective actions taken 

with respect to sanitation after an initial positive test result. The corrective actions require 

follow-up testing, including a targeted test of the specific site that is the most likely source of 

contamination by the organism, and other additional tests in the surrounding food contact 

surface area. You verify that if the establishment obtains a second positive test during followup testing, it will hold the lots of product that may be contaminated from contact with the food 

contact surface until a subsequent test result indicates that the sanitation problem is 

corrected. After a second positive Lm sample result, the establishment will also test each lot 

of product that may have become contaminated with Lm. The establishment will release the 

implicated product into commerce only after it has been tested and found free of Lm. If the 

sampled product tests positive for Lm, the establishment considers the product adulterated 

and withholds it from distribution. The establishment will then either destroy the held product 

or rework it using a process that is destructive to Lm. The establishment will also document 

the test results and product disposition. Based upon your review, you determine that the 

establishment is in compliance with 9 CFR 430.4(b)(3).
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VERIFYING COMPLIANCE

Gather Information

IPP should use the GAD thought process to verify compliance with Alternatives 1, 2, or 3. 

Alternative 2 is based on the same requirements as Alternative 1 except that the establishment 

can choose to use only a post-lethality treatment (Choice 1) or an antimicrobial agent or 

process (Choice 2). When verifying compliance with Alternative 1 and Alternative 2 

requirements, IPP should seek answers to the following questions:

1. Is the post-lethality treatment (which may be an antimicrobial agent) incorporated in a 

HACCP plan?

2. Does the establishment have scientific documentation supporting the effectiveness of its 

post-lethality treatment in accordance with §417.5(a)(2)?

3. Does the establishment have validation data for the post-lethality treatment in accordance 

with §417.4?

4. Is the establishment implementing the post-lethality treatment as described in the HACCP 

plan?

5. Has the establishment incorporated the use of the antimicrobial agent or process to 

suppress or limit the growth of Lm in its HACCP plan, its Sanitation SOPs, or a 

prerequisite program?

6. Is the establishment using the antimicrobial agent or process as described in its HACCP 

plan, its Sanitation SOPs, or a prerequisite program, and can it scientifically support how 

the antimicrobial agent or process is being used?

7. Has the establishment incorporated the use of the antimicrobial agent or process to 

suppress or limit the growth of Lm in its HACCP plan, its Sanitation SOPs, or a 

prerequisite program?

8. Is the establishment using the antimicrobial agent or process as described in its HACCP 

plan, its Sanitation SOPs, or a prerequisite program?

When verifying compliance with Alternative 2, Choice 2, or Alternative 3 requirements, IPP 

should seek answers to these questions regarding the establishment’s sanitation procedures.

1. Has the establishment incorporated sanitation measures in a HACCP plan, SSOP, or 

other prerequisite program?

2. Is the establishment’s food contact surface testing used to verify the on-going 

effectiveness of its sanitation procedures?

3. Does testing of food contact surfaces in the post-lethality processing environment ensure
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that the surfaces are sanitary and free of Lm or of an indicator organism?

4. Did the establishment identify the conditions under which it will implement hold-and-test 

procedures following a positive test of a food contact surface for an indicator organism?

5. Did the establishment state the frequency with which testing will be done?

6. Did the establishment identify the size and location of the sites that will be sampled?

NOTE: establishments should identify all possible FCS sites (AskFSIS QA dated 2-17-12)

7. Did the establishment include an explanation of why the testing frequency is sufficient to 

ensure that effective control of Lm, or an indicator organism, is maintained?

If an establishment produces a RTE deli product or hotdog product under Alternative 3, IPP 

should verify that the establishment:

1. Effectively implemented corrective actions (with respect to sanitation after an initial positive 

result on a food contact surface in the post-lethality processing environment) by follow-up 

testing that includes targeted testing of the specific site on the food contact surface area and 

other sites as necessary to ensure effectiveness of the corrective actions.

2. Holds product lots that may have become contaminated by contact with the food contact 

surface when the establishment obtains a second positive test for Lm or an indicator 

organism during follow-up testing until the problem is corrected as indicated by negative 

follow-up test results.

3. Sample and test product lots for Lm or an indicator organism using a sampling method and 

frequency that will provide a level of statistical confidence that ensures that each lot is not 

adulterated with Lm.

4. Documents testing results.

5. Reworks held product using a process that is destructive to Lm.

Assess Information

To answer these questions, IPP should:

 Review the HACCP plan.

 Review validation data (supporting documentation) for the post-lethality treatment.

 Review HACCP records.

 Review the Sanitation SOP and/or prerequisite programs associated with the use of the 

antimicrobial agent or process (as necessary).

 Review Sanitation SOP and/or prerequisite program records (as necessary).
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Determine Compliance

IPP must determine regulatory compliance after all available information pertaining to the 

Listeria Control Alternative selected has been gathered and assessed. There is no 

noncompliance if the establishment has met all regulatory requirements. If the establishment 

has not met all regulatory requirements, the noncompliance should be documented on an NR 

under the appropriate PHIS task as described in FSIS Directive 5000.1, citing the appropriate 

sections of §430.4(b), §417 for HACCP and prerequisite programs, and/or §416 for sanitation. 

IPP should verify that the establishment has taken effective corrective and preventive actions 

to bring itself into compliance with 9 CFR 430. Such actions may include a reassessment of the 

HACCP plan and the establishment’s choice of another alternative.

Alternative 1 Noncompliance Examples:

1. The establishment has a post-lethality treatment to reduce or eliminate Lm incorporated into 

the HACCP plan but does not have the use of the antimicrobial agent or process to 

suppress or limit the growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a 

prerequisite program. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

2. The establishment has the use of the antimicrobial agent or process to suppress or limit the 

growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a prerequisite 

program, but does not have a post-lethality treatment to reduce or eliminate Lm incorporated 

into the HACCP plan. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

3. The establishment is testing food contact surfaces in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Lm or of an indicator 

organism but does not have a post-lethality treatment to reduce or eliminate Lm 

incorporated into the HACCP plan OR the use of the antimicrobial agent or process to 

suppress or limit the growth of Lm incorporated into its HACCP plan, its Sanitation SOP, or a 

prerequisite program. (Cite §430.4(b)(1), 417.5(a)(1) & (2))

Alternative 2 Noncompliance Examples

1. The establishment is testing food contact surfaces in the post-lethality processing 

environment to ensure that the surfaces are sanitary and free of Lm or of an indicator 

organism but does not have a post-lethality treatment to reduce or eliminate Lm included in 

a HACCP plan OR an antimicrobial agent or process to suppress or limit the growth of Lm 

incorporated into a HACCP plan, SSOP, or a prerequisite program. Cite §430.4(b)(2), 

417.2,417.5(a)(1) & (2)

2. The written sanitation procedures the establishment is using to meet the requirements of 

Choice 2 only addresses the testing of non-food contact surfaces in the post-lethality 

processing environment to ensure that the surfaces are sanitary and free of Lm or of an 

indicator organism. Cite §430.4(b)(2), 416, 417.5(a)(1) & (2)

3. The written sanitation procedures the establishment is using to meet the requirements of 

Choice 2 do not identify the conditions under which or at what point hold-and-test
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procedures following a positive test of a food-contact surface for Lm or an indicator 

organism will be initiated. Cite §430.4(b)(2), 417.5(a)(1) & (2)

4. The written sanitation procedures the establishment is using to meet the requirements of 

Choice 2 do not identify the size of the sites to be sampled or explain why the testing 

frequency selected is sufficient to ensure that effective control of Lm or an indicator 

organism is maintained. Cite §430.4(b)(2), 417.5(a)(1) & (2)

Alternative 3 Noncompliance Examples

1. The establishment does not have sanitation measures incorporated in its HACCP, 

Sanitation SOP, or other prerequisite program. Cite §430.4(b)(3), 417.5(a)(1) & (2)

2. An establishment that produces deli and hotdog products does not conduct follow-up 

testing of target sites on the FCS area that is the most likely source of contamination after 

an initial positive test for Lm, or its indicator organisms, to verify the effectiveness of its 

sanitation corrective actions. Cite §430.4(b)(3), 417.5(a)(1) & (2)

3. An establishment that produces deli and hotdog products does not hold-and-test lots of 

product for Lm, or an indicator organism, that may have become contaminated by contact 

with the food contact surface when it obtains a second positive test for Lm, or an indicator 

organism, during its follow-up testing. Cite §430.4(b)(3), 417.5(a)(1) & (2)

Documentation and Enforcement

If noncompliance with the Lm regulations is found, IPP are to issue an NR under the appropriate 

HACCP or SSOP task as described in FSIS Directive 5000.1, citing 9 CFR 430.4(b)(1), (2), or

(3) and the appropriate sections of 9 CFR 417 or 416 if applicable. IPP are to verify that the 

establishment has taken effective corrective actions to bring itself into compliance with 9 CFR

430. Such actions may include, but are not limited to, a reassessment of the HACCP plan and 

the establishment’s choosing of another alternative or determining that the decisions it made 

in the hazard analysis regarding the use of a prerequisite program remain valid.

If an establishment is producing post-lethality exposed products and has failed to meet any of 

the requirements of 9 CFR 430, IPP should contact the District Office through supervisory 

channels. A NOIE may be issued if the establishment HACCP system and/or SSOP is 

inadequate due to failure to meet the 9 CFR 430.
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ATTACHMENT 1: CONTROL REQUIREMENTS for Listeria MONOCYTOGENES

Requirements

 Increasing Risk Levels and Frequency of FSIS Verification Testing 

ALTERNATIVE 1 ALTERNATIVE 2 ALTERNATIVE 3

Post-lethality 

Treatment AND

Antimicrobial 

agentorProcess

Post-lethality Treatment OR

Antimicrobial agent or Process

Sanitation and Testing

Program

Choice 1:

Post-lethality

Treatment

Choice 2:

Antimicrobial

AgentorProcess

Non-deli,

Non-hotdog

Deli or hotdog product

Validate effectiveness of post-lethality treatment (PLT). 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 X 

Document effectiveness of antimicrobial agent or process: Must be

included as 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.

X X 

Sanitation Program Requirements X X X

Testing food contact surfaces (FCS) in the post-lethality processing 

environment for Lm or an indicator organism. X X X 

State testing frequency. X X X

Identify size and location of sites to be sampled. X X X

Explain why testing frequency is sufficient to control Lm or an indicator

organism. X X X 

Identify conditions for Hold-and-Test, when FCS (+) for Lm or an indicator

organism. X X X 

Additional Sanitation Program Requirements

Effective after 1stFCS (+) for Lm or an indicator organism. Includes testing

of targeted FCS as most likely source and additional testing of the

surrounding area.

X 

If follow-up testing yields 2nd 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 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.

X 

Establishments in all three alternatives must maintain sanitation in

accordance with 9 CFR 416. X X X X X 
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30 Sampling Ready-to-Eat (RTE) Product

Objectives:

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

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. Explain what IPP should consider when scheduling RTE samples.

7. Describe why it is important to notify establishment management prior taking a 

sample.

8. Explain how FSIS samples are documented.

9. Describe the process for ensuring sample integrity, from sample collection until 

sample is shipped.

10. List the items that are packed into the sample container.

11. Identify how IPP obtain sample results.

12. Describe what actions IPP take when a positive FSIS RTE sample result is 

identified.

13. Describe the actions IPP take when establishment testing obtains a positive sample 

result.

14. Explain the procedures in verifying corrective actions for a positive RTE sample.

15. Identify the two sampling programs that EIAOs may perform in RTE establishments.

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.
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The pathogens of public health concern are Listeria monocytogenes and Salmonella

• Salmonella usually indicates a breakdown in lethality step

• Lm usually indicates post-lethality contamination

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

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).

Intact package. This is product in the final packaged form (immediate container) in which it will be 

shipped.

Sampled lot is the amount of product represented by the sample.

There are 6 general steps in sampling RTE product:

1. Determine which product to sample and schedule the sample

2. Notify establishment management

3. Collect the sample

4. Document the sample

5. Pack and ship the sample and form

6. Respond to the results

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 

based on the highest risk level.

Before collecting a sample, IPP are to officially notify the establishment management that they will 

be collecting a sample and explain the reason they are collecting the sample.
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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 onepound sample of product in an intact package.

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 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.

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)

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.

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 proper disposition of the 

sampled product lot.
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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.

EIAOs trained in the IVT methodology collect samples under the Intensified Verification 

Testing (IVT) program which involves collecting product, food contact, and environmental 

(non-food contact) samples. This sampling is typically done “for cause” (e.g., positive 

sample results).

EIAOs trained in the IVT methodology also collect samples under the Routine Risk-based 

Lm (RLm) sampling program when conducting routine FSAs in establishments that 

produce RTE products.

https://www.fsis.usda.gov/sites/default/files/media_file/2020-08/10240.4.pdf

https://www.fsis.usda.gov/sites/default/files/media_file/2022-03/10240.3.pdf
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31 HACCP System and Recall Verification

Objectives

1. Explain the regulatory thought process, define its four components, and identify key 

aspects of each component.

2. Understand four essential questions to consider in determining when to document a failure 

to meet HACCP regulatory requirements.

3. Use the regulatory thought process to determine if a food safety system is inadequate.

4. Identify three types of enforcement actions taken when a noncompliance determination is 

made.

5. Identify two scenarios when a HACCP verification plan is necessary.

6. Verify that establishments maintain written recall procedures per 9 CFR 418.3 

requirements.

Introduction

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 ALL 

of the following:

• Hazard analysis.

• HACCP plan.

• Supporting documentation including prerequisite programs used to make decisions in 

the hazard analysis.

• HACCP records generated on an ongoing basis.

In using the regulatory thought process to determine if wholesome, unadulterated products are 

being produced, IPP are actually verifying the overall effectiveness of the establishment’s 

HACCP system. Verifying whether individual product units are wholesome is less important 

than determining the overall effectiveness of the establishment’s comprehensive HACCP 

system.

HACCP Regulatory Process

The diagram in module 13 (HACCP Regulatory Process) shows the HACCP regulatory 

process, which includes the following four components:

• Inspection Methodology

 Performing HACCP inspection tasks

 Verifying specific HACCP regulatory requirements by performing the HACCP 

inspection task
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• Decision-making (GAD)

 Gathering information, making observations, reviewing documentation, assessing the

gathered information, arriving at a supportable compliance determination

• Documentation

 Entering HACCP inspection task results (observations and determinations) in PHIS

 Documenting noncompliance on a Noncompliance Record (NR)

 Associating noncompliance from the same cause

• Enforcement

 Following the Rules of Practice (ROP)

 Providing the establishment with due process

FSIS Responsibilities

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

Directives 5000.1 and 5000.6. IPP are responsible for understanding and properly performing 

in PHIS the HACCP inspection tasks described in these Directives.

Inspection Methodology

To verify that establishments are complying with 9 CFR Part 417, IPP perform two HACCP 

inspection tasks: The Hazard Analysis Verification (HAV) task and the HACCP Verification 

Task. The HAV Task directs IPP to review the establishment’s hazard analysis, prerequisite 

programs, and other supporting documentation for one HACCP plan. The HACCP Verification 

Task focuses on verifying the implementation of the establishment’s HACCP plans, prerequisite 

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

performed as a routine or directed task, has two verification components:

• Recordkeeping (RK)

• Review and Observation (RO)

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

compliance.

Decision-Making (GAD)

IPP should use the regulatory GAD (Gather, Assess, and Determine) thought process to 

perform the HACCP inspection tasks. IPP are to gather all available information to help them 

determine regulatory compliance. This may include:

• Reviewing hazard analyses, HACCP plans, prerequisite programs, supporting 

documentation, and ongoing monitoring records, HACCP plans, SSOPs, 

prerequisite programs, and other supporting programs or procedures.

• Observing establishment employees performing or implementing HACCP, SSOP, or 

prerequisite program or other supporting program procedures, and occasionally taking 

measurements as specified in HACCP system documents.
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After reviewing the gathered information, IPP are to assess the significance and meaning of 

information gathered by:

• Comparing the information gathered to HACCP regulatory requirements.

• Considering how each piece of information, either taken separately or with other findings, 

supports that the HACCP system is functioning as intended.

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

(e.g., Is this an isolated or recurring problem? Are conditions getting worse? Is the 

establishment responding effectively and in a timely manner to problems?)

HACCP system noncompliance is a failure to meet any of the regulatory requirements outlined 

in 9 CFR Part 417. If a HACCP system noncompliance is identified, the establishment is 

expected to take immediate and further planned actions to come back into compliance. Before 

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

requirements as a noncompliance, they should consider the following four questions:

1. Did the establishment identify the failure to meet regulatory requirements or deviations from 

a critical limit?

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

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

meet regulatory requirements, or has it taken corrective actions to address the deviation in 

accordance with 9 CFR 417.3?

4. Is a trend developing (i.e., has the establishment failed to carry out the actions in 1 through 

3 above for similar situations)?

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

information (e.g., ongoing verification records).

There is no noncompliance if the answer to questions 1, 2, and 3 is “yes” and “no” for question 

4 because the establishment identified and addressed the situation. IPP would verify and 

document compliance with the applicable regulations in PHIS because the establishment’s 

response included the further planned actions and preventive measures for the noncompliance 

or deviation. The ability to track developing trends would not be adversely affected by not 

issuing an NR.

However, if the answer to questions 1, 2, or 3 is “no” or question 4 is “yes,” a noncompliance 

exists. IPP would document the noncompliance in PHIS and generate an NR. IPP should 

discuss with their supervisor any concerns whether the information supports a particular 

compliance determination.

HACCP System Compliance

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

noncompliance. IPP must also consider what their positive, negative, or inconclusive findings 

indicate about the overall effectiveness of the establishment’s HACCP system. It is important 

that each piece of information be considered in the context of the HACCP system and the 

potential for product adulteration. The following questions will help IPP to consider the 

significance of each finding for the HACCP system:
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• Is this information part of a pattern or trend? For example, is the establishment missing 

a measurement for a prerequisite program an isolated incident or has the establishment 

regularly failed to implement its prerequisite programs?

• Is there other information to indicate that the HACCP system is working or is not 

working? For example, if an establishment’s prerequisite program specifies product will be 

received with supplier certificates of analysis (COA) and periodically tested but the 

establishment failed to receive a COA for a particular product, how did they respond on 

whether or not to use the product?

• Does the information seem to agree with the other available information about the 

food safety system? For example, an establishment uses a prerequisite program to 

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

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

particular hazard finds positive results.

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

example, an establishment that uses a prerequisite program to prevent E. coli O157:H7 in 

incoming beef has COAs and verification test results on incoming trim that indicate the 

hazard is not reasonably likely to occur, but the establishment gets a positive test result on a 

finished product lot. The finished product test result calls into question the effectiveness of 

the prerequisite program as means of supporting the decision that E. coli O157:H7 is not 

reasonably likely to occur.

Inadequate HACCP System Determination

By considering the preceding questions, IPP can determine whether the information supports a 

finding of HACCP system regulatory compliance:

• Has adulterated product been produced or shipped?

• Is the HACCP system effectively controlling the relevant food safety hazards?

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

If noncompliance is found, IPP need to determine if it indicates an inadequate HACCP system.

Depending on the problems identified, the establishment may need to reassess the hazard 

analysis and HACCP plan. For example, if an establishment has not identified E. coli O157:H7 

as a food safety hazard reasonably likely to occur, tests outside the HACCP plan or SSOP, and 

gets a positive result, a reassessment of its HACCP plan and hazard analysis would then be 

required by 9 CFR 417.4(a)(3). The establishment must support the decisions made during the 

reassessment as specified in 9 CFR 417.5(a)(1) & (2).

If the establishment did not reassess its HACCP plan and hazard analysis as required by 9 

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

§417.5(a)(1) &(2), IPP cannot determine that the HACCP system meets the requirements of 9 

CFR 417.6. Consider the following questions to determine if there is an inadequate HACCP 

system:

1. Does the HACCP plan meet the regulatory requirements of 9 CFR Part 417?

If an establishment did not implement all or some of its HACCP plan or did not meet regulatory 

requirements, IPP would be unable to determine whether or not the establishment was 

producing unadulterated product in compliance with 9 CFR Part 417. For example, the HACCP
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system is inadequate if an establishment does not maintain any records associated with its 

HACCP plan, does not monitor critical limits at any CCP, or did not reassess or modify its 

HACCP plan when necessary.

2. Was adulterated product produced or shipped?

The HACCP system is inadequate if it did not prevent the production and distribution of 

adulterated product. For example, if an establishment failed to meet a critical limit for a CCP 

and did not take corrective actions per 9 CFR 417.3 but performed a pre-shipment review, the 

HACCP system is inadequate.

3. Is there a trend in establishment noncompliance?

Trends in the regulations cited on NRs are a key factor in determining if an establishment’s 

HACCP system is inadequate. Two or more NRs citing the same regulations and recurring 

noncompliance descriptions addressing similar causes may be a trend that indicates the 

HACCP system is inadequate.

No specific number of incidents constitutes a trend because of the variabilities in processing 

environments and HACCP plans. IPP should closely review the noncompliance descriptions 

contained in Block 10 of the NR form and not rely solely on the number of linked NRs to indicate 

a possible trend in noncompliance. Careful analysis of the regulations cited and written 

descriptions of noncompliance are necessary when determining if a trend indicates that the 

HACCP system may be inadequate.

Action toTake If an Inadequate System Exists

After determining that an inadequate HACCP system exists, IPP would take action and notify 

the District Office via supervisory channels. If adulterated product was produced and shipped in 

commerce, IPP would take an immediate withholding action according to the Rules of Practice.

DOCUMENTATION

Completing a Noncompliance Record

When documenting noncompliance on an NR, identify each noncompliance. Be specific, 

thorough, and include the time and location. Explain that establishment management received 

notification and state any regulatory control actions taken. Consult FSIS Directive 5000.1 and 

the PHIS User Guide for further information about completing the NR.

Throughout this course, you have learned that noncompliance is documented when it is 

observed, and the same causes of noncompliance are associated when they are identified. 

Documenting and associating noncompliance is not only useful in identifying trends, it also 

enables the Agency to provide establishments with due process and to take enforcement action 

when necessary.

If IPP document multiple or recurring noncompliance, they could request (through their chain of 

command) that the DO issue a Notice of Intended Enforcement Action (NOIE) to the 

establishment per §500.4. A request for an NOIE should come as no surprise. In reaching this 

conclusion, IPP should have been discussing the noncompliance trend with the establishment 

during weekly meetings and keeping the FLS or IIC apprised of what was happening.
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Enforcement Rules of Practice

The Rules of Practice (ROP) in 9 CFR 500 provide establishments with due process. They also 

describe how and under what circumstances the Agency progresses with further enforcement 

actions. Enforcement action may be necessary to prevent adulterated product from being 

produced and shipped. In accordance with the Rules of Practice, enforcement action could be 

one of three types.

1. Regulatory Control Action - The retention of product, rejection of equipment or facilities, 

slowing or stopping of lines, or refusal to allow the processing of specifically identified 

product.

2. Withholding Action - The refusal to allow the marks of inspection to be applied to 

products. A withholding action may affect all product in the establishment or product 

produced by a particular process.

3. Suspension - An interruption in the assignment of program employees to all or part of an 

establishment.

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

affect whether inspection verification activities will be performed.

Regulatory Control Actions

FSIS may take a regulatory control action (RCA) for insanitary conditions or practices, product 

adulteration or misbranding, conditions that preclude FSIS from determining that product is not 

adulterated or not misbranded, or inhumane handling or slaughtering of livestock.

An RCA allows IPP to prevent the movement of the affected product or use of the equipment or 

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

establishment prior notification that they are about to execute a RCA. IPP will take the RCA 

(e.g., retaining product, rejecting the equipment or room with a tag) and then complete an NR. 

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

compliance.

If there is SPS or SSOP noncompliance with direct product contamination or adulteration, IPP 

will verify that the establishment addressed the noncompliance by meeting the requirements of 

either 9 CFR 416 or 9 CFR 417, including corrective actions. An NR will be written, citing the 

appropriate SSOP or HACCP regulations. The establishment may need to re-evaluate the 

effectiveness of its procedures in its HACCP plan or SSOP and modify them if they are no 

longer effective in preventing contamination or adulteration of product.

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

establishment effectively implemented corrective actions that meet the requirements of

§417.3(b). These corrective actions should include a reassessment to determine whether the 

unforeseen hazard should be incorporated into a HACCP plan. Regulatory control actions are 

not frequently used for HACCP regulatory noncompliance unless control is necessary to prevent 

shipment of contaminated or adulterated product.

Examples of common regulatory control actions related to slaughter include stopping a line or 

retaining a carcass as a result of a slaughter food safety standard finding.
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Withholding Actions Without Prior Notice

It may be necessary for IPP to take immediate enforcement actions without giving the 

establishment prior notice to prevent an imminent threat to public health. For example, IPP 

would need to take an immediate withholding action if an establishment produced and shipped 

adulterated product. In this situation, the immediate withholding action would be taken and then 

the District Office and supervisor would be notified as soon as possible. Refer to the ROP 

module for additional information.

Withholding and Suspension Actions With Prior Notification

Some withholding and suspension actions require prior notification according to the ROP. The 

most common withholding or suspension actions related to HACCP noncompliance are those in 

which the HACCP system is inadequate due to multiple or recurring noncompliance. 

Withholding or suspending inspection for this cause requires prior notification to the 

establishment. The prior notice is in the form of a written Notice of Intended Enforcement Action 

(NOIE). Remember that a suspension may only be issued by a District Manager or higher FSIS 

official.

District Office Notification

After determining that an inadequate HACCP system may exist, IPP should notify the District 

Office and request that a Notice of Intended Enforcement (NOIE) be issued to the 

establishment. The DO will provide direction about any further actions that may need to be 

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

District Office Determines Enforcement Action

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

enforcement action based upon the ROP.
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FSIS prepares a verification plan 

based on the establishment’s 

proposed corrective actions

Corrective actions were either not 

fully implemented or were 

ineffective. FSIS reinstates the

suspension

Corrective 

actions are 

implementedby

the 

establishment 

and are 

effective. FSIS 

closes out the 

suspensionwith

a Letter of

Warning(LOW)

Establishment’s 

response does 

not adequately 

address the 

issuesintheNOS. 

The suspension 

remainsin effect 

untilthe issuesin 

the NOS are 

adequately 

addressed

Establishment responds 

including proposed corrective 

actions

Establishmentdoesnot

respond to the NOIE

Establishment responds

including proposed corrective 

actions

FSISdefersenforcement 

to allow the 

establishment to 

implement proposed 

corrective actions

Establishment’s 

response does not 

adequatelyaddress

the issues 

addressed in the 

NOIE

FSIS suspendsthe assignment of 

programemployeesto all or part 

of the establishment

Corrective actions were either 

notfully implemented or were 

ineffective. FSIS closes out the 

NOIE by suspending the 

assignment of program 

employeesto all or part ofthe 

establishment

FSIS holds the suspension in 

abeyance to allow the 

establishment time to implement 

proposed corrective actions

Notice of Intended Enforcement Action

Establishment has 3 business daysto respond

FSIS prepares a verification plan based

on the establishment’s proposed 

corrective actions

Corrective actions are 

implemented by the 

establishment and are 

effective. FSIS closes outthe 

NOIE with a Letter of

Warning (LOW)
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Verification Plan

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

is allowed time to implement proposed corrective actions. A verification plan (VP) is developed 

by the EIAO with input from the in-plant inspection team, FLS, and DO. A VP captures all of the 

corrective actions the establishment stated they would do and provides a systematic means for 

FSIS to verify that an establishment is effectively implementing the proffered corrective 

measures.

A Verification Plan:

 Describes the verification activities to be performed by inspection personnel based on 

the establishment’s corrective measures.

 Lists the procedures and frequency for each verification activity.

 Identifies the regulatory citation for each verification activity.

IPP schedule and perform the directed verification activities identified in the VP, which typically 

lasts for 90 days and is updated every 30 days. On a weekly basis, the in-plant team reports the 

results of the activities conducted under the VP, via e-mail to the District Office. The in-plant 

inspection team has the flexibility to increase the frequency of the verification activities based on 

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

support FSIS imposing further enforcement actions.

RECALLS

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

(e.g., a positive pathogen sample result is obtained for product the establishment already has 

shipped). FSIS Directive 8080.1, “Recall of Meat and Poultry Products,” details all verification 

requirements for recalls.

NOTE: Product is “in commerce” if it is out of the producing establishment’s direct control and 

is in distribution (e.g., in a warehouse, distribution center, retail facility, restaurant, or other 

institution).

Establishment Recall Requirements

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

Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall 

Procedures, and Document Certain Hazard Analysis and Critical Control Points System Plan 

Reassessments” (77 FR 26929). The rule requires official establishments to:

1. Notify the local FSIS DO within 24 hours of learning or determining that an adulterated or 

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

has entered commerce (9 CFR 418.2). The 24-hour period begins once an establishment 

believes that a product in commerce is adulterated or misbranded under the FMIA or PPIA 

(e.g., final results of a laboratory analysis show that raw ground beef contains E. coli 

O157:H7 or product contains an allergen that is not declared on the product label).

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

produced and shipped by the establishment (9 CFR 418.3).
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3. Prepare written recall procedures as required by 9 CFR 418.3 before being granted Federal 

inspection (9 CFR 304.3(a) and 381.22(a)).

NOTE: There may be situations in which laboratory results are not available, but 

epidemiological evidence indicates there may be a probability of harm from consuming the 

product. Under these circumstances, official establishments should consider the strength of 

the epidemiological evidence to determine whether there is reason to believe that the 

product is adulterated or misbranded.

When notifying the DO that an adulterated or misbranded meat or poultry product was received 

by or originated from the official establishment, establishment officials should provide the type, 

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

The DO is to notify the Recall Management and Technical Analysis Division (RMTAD) as soon 

as possible after notification. If establishments contact other FSIS personnel, those employees 

are to contact RMTAD promptly through supervisory channels.

The DO and possibly the RMTAD evaluate each situation on a case-by-case basis (see FSIS 

Directive 8080.1, “Recall of Meat and Poultry Products”). The RMTAD coordinate any recall 

activities and are to be notified immediately if product has left the establishment’s control. The 

RMTAD is also notified so that a press release can be issued and recall effectiveness checks 

can be performed.

More or less product may be determined to be “affected product” when all factors are 

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

similar HACCP plan have been affected, what pathogens are involved, whether there have been 

any other incidents of contamination in the establishment associated with the pathogen, and 

whether there have been persistent and recurring noncompliance in the establishment).

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

commerce. If the establishment does not voluntarily recall product, the DO will coordinate 

actions to detain or seize affected product.

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

poultry product produced and shipped by the official establishment. FSIS Directive 5000.8, 

“Verifying Compliance with Requirements for Written Recall Procedures,” dated 12/18/2013, 

outlines the details of how to verify the requirements of 9 CFR 418.3.

FSIS Verification

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

that establishments have written recall procedures. If IPP determine that the establishment has 

written recall procedures, they are to document in PHIS that they performed the task, and that 

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

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

noncompliance record, citing 9 CFR 418.3.
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HACCP Regulatory Process

Inspection Methodology Decision Making Documentation Enforcement

1. Perform 

HAV Task

4. Complete 

Task in PHIS

3.

Noncompliance 

Identified?

7. Verify Corrective 

Actions and complete

the NR in PHIS

2. Perform 

HACCP

Verification 

Task

5. If

Necessary, 

Take RCA 

Following 

ROPs and 

Document NR

6.

Inadequate 

System?

8. Follow 

ROPs

and 

notify 

the 

District 

Office

9. The 

District

Office will 

determine 

the 

appropriate 

enforcement 

action based 

on ROPs
222

32 Export Certification

Objectives:

1. Describe how to perform the Inspection Verification.

2. Describe where to locate current export requirements.

3. List the reasons why a Certifying Official would not sign an export certificate.

4. List the reasons when a replacement export certificate can be issued.

5. Describe when to write a Memorandum of Interview related to export certification.

6. Who administers the Export Verification, Quality System Assessment Program (EV/QSA)?

7. How to navigate through PHIS Electronic Export module.

Resources:

FSIS Export Library - https://www.fsis.usda.gov/inspection/import-export/import-export-library

Directive 9000.1 – Export Certification

Directive 12,600.1 – Voluntary and Other Reimbursable Inspection Services 

Directive 13,000.5 – Public Health Information System Export Certification

Notice 09-23 – Seven-Digit Export Stamp, Enhanced Digital Signature, Plain Paper Printing, 

and Statements Module for Use With the Export Module of the Public Health Information 

System - Phase Eight

For phase six through eight countries (see future Notices also), IPP are to print the approved 

export certificates on standard white copy paper (8.5” x 11”) from the View Export Records 

(9060) grid, but only for establishments that do not have functional printers or PHIS access, as 

indicated in Section VI below. All other establishments will print the approved export certificates 

on standard white copy paper (8.5” x 11”) from the Create/View 9060-6 Export Applications 

(9060) grid in PHIS, as indicated in Section III below. IPP are not to print from PHIS on FSIS 

security paper (item number ECP-11) except for countries that require it as documented in the 

Export Library.

The certifying official (CO), any FSIS official who signs the completed export certificate (9060- 

5), verifies the information on the export certificate comparing to the information on the signed 

export application (9060-6) and the country requirements in the FSIS Export Library. The CO 

may not be directly associated with the production or inspection of exported product. IPP 

perform a physical check of containers, labels, and product. If after checking the Export Library 

and the product you believe that products listed on the application are not eligible for export to 

the country listed on the application, first discuss your concerns with the exporter. Then, write a 
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memorandum of interview (MOI) detailing your discussions and whether your concerns were 

addressed adequately. Give a copy of the completed MOI to the exporter and file a copy in the 

inspection file.

Means of stamping

The USDA export stamp is an accountable item that must be held under control. The stamp is 

applied to the container. Establishments may also use computer-generated stickers. Stickers 

must be the exact size and impression as the export stamp, must be printed with authorization, 

must be based on assigned export number, and the establishment must identify number of 

stickers produced prior to applying. They must give all unused stickers to the inspector upon 

completion. Establishments may also perform direct inkjet printing of the export mark to the 

carton or container. You are to verify that the inkjet mark is equal in size and an exact 

impression of the FSIS rubber export stamp. They should also not be printed on the cartons or 

containers until authorized by you, should only be applied in the quantity needed for application 

to the consignment, and the establishment should notify you in advance of the quantity of 

cartons or containers to be printed. Applying the export mark to the cartons or to the containers 

should be done under the supervision of a designated plant employee.

A unique identifier (UI) is an alternate export mark that may be used for export consignments 

instead of using the standard USDA export mark that contains the export certificate number. 

The UI may be any combination of numbers or letters. IPP are not to certify export 

consignments marked with a UI unless the importing country allows containers to be marked 

with a UI. The applicant should link the UI to the corresponding export certificate by including 

the following statement in the remarks section of the export certificate or on FSIS Form 

9060-5B (remarks continuation page); “The products covered by this certificate are marked 

with the Unique Identifier X#X#X#X#X#XX#X#.”

Pre-stamping

Under some conditions, establishments can pre-stamp the product. Pre-stamping occurs when 

the establishment stamps the boxes and completes the export certificate when you are not 

present.
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FSIS Form 9060-5 (Export Certificate of Wholesomeness) are accountable items and should be 

maintained secured. Keep a record of the issued and voided certificate numbers at the 

establishment. When completed, the CO reviews the certificate. The country requirements show 

if the importing country needs additional certificates, which are usually hyperlinked in the Export 

Library.

Before signing the certificate, the CO should check the certificate for corrections, check for 

attachments and ensure that the exporting firm has lined-out any unused space. If you have 

questions about the information on the application, the export certificate, or other supplemental 

documents, do not to sign the certificate until you seek clarification. If you still have concerns 

about signing the export certificate after reviewing the completed export documents and 

performing product re-inspection or export verification activities, discuss the concerns with 

establishment management. Document the discussion with establishment management in an 

MOI and identify any of their concerns that cannot be resolved. Provide a copy of the MOI to 

establishment management and retain a copy for the government file. Document any regulatory 

noncompliances by issuing an NR, notify the supervisor of your concerns, and describe the 

establishment’s plan to address the concerns. Do not sign the export certificate.

A replacement certificate is to be issued for one of the following reasons:

• Original certificate did not contain required information;

• Original certificate contained incorrect information, importer, exporter, consignee, 

or consignor has changed, but is within the same country that appears on the 

certificate.

If the certificate is lost, IPP are not to issue a replacement certificate unless the exporter 

provides a letter of assurance to the CO stating the certificate will be returned if found. The 

replacement certificate only restates the information contained on the original certificate or if 

the country of destination has changed. The exporter may split or consolidate a shipment with 

stamped pallet or conveyance. The Remarks section for a replacement certificate must contain 

the statement as follows: “This certificate replaces certificate number (insert original 

certificate number(s) dated (insert date(s) of the original certificate(s)). The export mark 

covered by the certificate shows certificate number (insert original certificate number).”
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Export Verification/Quality System Acceptance (EV/QSA)

Establishments which want to participate in this program must first contact the Agricultural 

Marketing Service (AMS), who approves by auditing and notifies FSIS Office Program and 

Policy Development (OPPD) and Import/Export Policy Development Staff (IEPDS), then 

notifies the appropriate DO. You will need to check the country requirements in the Export 

Library to verify the receiving country participates in EV/QSA. IPP check that the product codes 

are approved for export and if the country requires a Statement of Verification (SOV) for the 

exported product. IPP also check that the applicant supplied a copy of the SOV with the 

completed export application, completed additional certificates, and completed export 

certification when presenting for IPP signature. In addition, IPP check if supporting documents 

such as lab sampling results are available, although not all countries will require all these 

steps. The exporting facility must obtain the SOV confirming that the EV/QSA program met the 

country requirements and that the products are eligible for export before the FSIS certifying 

official signs the completed export certificate. Establishments that need to obtain an SOV for 

export must contact AMS directly. If there is improper execution of the EV/QSA, notify AMS 

with the following information: establishment name, address, product type, product code, 

quantity of product, date of production, lot number, shift produced, date and nature of 

observation, name of country for which product is intended, export certificate number, any 

other information to verify claim, and name of IPP documenting concerns. If any of the 

problems with the EV/QSA requirements are also regulatory non-compliances, take the 

appropriate enforcement actions and issue an NR.

Reimbursable export activities include: familiarizing with requirements in the Export Library, 

conducting and documenting inspection or certification activities required by an EV/QSA 

program, conducting and documenting any other additional inspection or certification activities, 

reviewing foreign country label requirements and certifications requiring a PHV signature, and 

approval and issuance of all replacement export certificates.

Export activities are recorded in PHIS. Each day IPP issue an export certificate at an official 

establishment, they are to schedule and document one domestic Export Certification task in 

PHIS. Regardless of the number of export certificates issued or the number of IPP that issue 

certificates on a given day, IPP are only to record the task as performed once each day, per 

shift and not for each inspector or export certificate they issue. If performing export 

certification activities in PHIS, each export application will appear as a separate task.
226

33 Food Defense

OBJECTIVES

1. Explain the risk that intentional contamination presents to FSIS-regulated products.

2. Define the following terms:

a. Food safety

b. Food defense

c. Food defense practices

d. Supply chain

e. Food defense vulnerability

3. List the characteristics of a functional food defense plan.

4. Recognize examples of vulnerabilities and associated food defense practices.

5. Describe the purpose of the food defense task.

6. Identify measures an establishment can take to protect their product from intentional contamination.

7. Explain how inspectors are to perform the Food Defense task and document food defense 

vulnerabilities in the Public Health Information System (PHIS).

FOOD DEFENSE TERMINOLOGY

Food Defense – The protection of food products from intentional contamination or 

adulteration intended to cause public health harm or economic disruption. Food Defense is 

an integral part of FSIS’s mission in protecting public health. The mission of the FSIS Food 

Defense Program is to protect the U.S. food supply from dynamic and evolving threats.

Food Security – Ensuring all people at all times have both physical and economic access 

to enough food for an active, healthy life. Food security includes both physical and 

economic access to food that meets people's dietary needs and food preferences.

Therefore, the concept of food security certainly includes but encompasses much more 

than the idea of food defense.

Food Safety – Guarding against unintentional contamination of food. HACCP plans and 

Sanitation SOPs, which are developed based on what can be predicted to happen if we do 

not put safety measures at critical points, are used to guard against unintentional 

contamination.

Food Defense Practices – Policies, procedures, or countermeasures to mitigate 

vulnerability to intentional contamination.
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Critical Infrastructure – Defined in the Patriot Act of 2001 as systems and assets, whether 

physical or virtual, so vital to the United States that the incapacity or destruction of such 

systems and assets would have a debilitating impact on security, national economic 

security, national public health or safety, or any combination of those matters. The Food and 

Agriculture Sector is one of 16 critical infrastructures identified by the Patriot Act.

Supply Chain – Continuous process, including every step involved in food production and 

food reaching the consumer; often referred to as “farm-to-table” or “farm-to-fork.”

FOOD DEFENSE VULNERABILITIES AND FOOD DEFENSE PRACTICES

A vulnerability can be any part of the food production or storage system where a protective 

measure should be implemented to protect a product from intentional adulteration, but such a 

measure is found to be missing or not in place.

Food defense vulnerabilities are weaknesses within the food production process that make it 

easy to intentionally contaminate product.

An establishment can put food defense practices (also called mitigation strategies) into place 

to reduce the likelihood that intentional contamination will occur. Food defense is not a onesize-fits-all approach! Food defense practices that are implemented to protect products within 

a large establishment may not be effective or may not be necessary in a small or very small 

establishment. This should be considered when inspection program personnel (IPP) conduct 

their food defense activities.
228

FOOD DEFENSE IN FSIS-REGULATED ESTABLISHMENTS

Food defense is voluntary for FSIS-regulated establishments.

A functional food defense plan is an approach to identify and mitigate vulnerabilities; it can 

help an establishment prevent, protect against, respond to, and recover from an intentional 

contamination incident. A food defense plan is functional when it meets all four of the following 

criteria:

1. Developed – The plan is documented and signed.

2. Implemented – Food defense practices identified in the plan are actually implemented.

3. Tested – Food defense measures are monitored and validated to ensure they are 

working.

4. Reviewed and maintained – The plan is reviewed at least annually and revised as 

needed.

Note: An establishment must be implementing the elements of its food defense plan in order 

for FSIS to consider it “functional.”

IPP are responsible for maintaining the functional food defense plan status for an establishment 

in the Establishment Profile in PHIS. This status should be updated per the frequency identified 

in Directive 5300.1, Managing the Establishment Profile in the Public Health Information 

System, or when IPP become aware of a change in the establishment’s functional food defense 

plan status.

NATIONALTERRORISM ADVISORY SYSTEM

The National Terrorism Advisory System (NTAS) is a system managed by the Department of 

Homeland Security (DHS) to communicate information about terrorist threats by providing 

information to the American public.
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PERFORMING FOOD DEFENSE TASKS IN PHIS

IPP in meat and poultry establishments are to perform the Food Defense task as assigned in 

PHIS. PHIS will automatically generate one routine Food Defense task per quarter to the 

establishment Task List. This task has a priority 3 in the establishment Task List, including a 

start/end date window of three months. Only one questionnaire is to be completed per 

establishment. The task is to only be performed on one shift in multi-shift establishments. The 

supervisor should determine which shift performs the task. The shift that does not complete the 

task should mark the task as not performed with a justification of ‘Task assigned to another 

inspector.’

IPP perform the Food Defense task to identify vulnerabilities within establishments that may 

lead to intentional contamination of FSIS-regulated products.

In the case of a NTAS alert identifying an elevated or imminent threat to food or agriculture, the 

inspector-in-charge (IIC) will receive specific instructions through supervisory channels on other 

measures to take.

SUMMARY

Defending the food supply against intentional contamination is a critical function. IPP, both in 

and outside of establishments, serve as the Agency’s eyes and ears to help identify 

vulnerabilities that may lead to intentional contamination. IPP are responsible for three 

activities related to food defense:

1. Updating the functional food defense plan status in the PHIS establishment profile 

and ensuring it is accurate;

2. Performing food defense tasks;

3. Submitting a food defense MOI when food defense vulnerability is observed and 

discuss with establishment management.

Implementation of Food Defense tasks serves to protect the public, which is essential to our 

mission, and ensures the security of our food, a vital component of homeland security.

Report any suspicious activities in establishments to your District Manager through supervisory 

channels or call the FSIS 24-hour emergency hotline at 1-866-395-9761.
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34 Non-Food Safety Consumer Protection (NFSCP)

Objectives:

1. Identify the statutes, regulations and primary directives that relate to non-food safety 

consumer protection responsibilities.

2. Explain what to do when noncompliance is observed with the Non-Food Safety 

Consumer Protection Tasks.

3. Explain the regulatory requirements for products that are subject to standards of 

identity.

4. Explain the purpose of the Non-Food Safety Consumer Protection Tasks.

The Non-Food Safety Consumer Protection (NFSCP) requirements are verified by Other 

Consumer Protection tasks to determine that establishments are complying with regulatory 

requirements designed to protect the consumer in ways other than ensuring food safety, 

such as economic adulteration and misbranding.

Statutes

Let’s start by reviewing the statutes in the Federal Meat Inspection Act (FMIA) related to 

NFSCP requirements. The term “misbranded” is defined in 21 U.S.C. 601(n) of the FMIA. There 

are twelve parts to this definition. Misbranded is defined in the FMIA as a meat product that:

• Part (1), has labeling which is false or misleading.

• Part (2), is offered for sale under the name of another food.

• Part (3), is an imitation of another food.

• Part (4), has a container that is misleading.

• Part (5), has a label that fails to show the name and place of business that produced the 

product, or fails to contain an accurate statement of the quantity of the contents of the meat 

product.

• Part (6), contains a label that is missing required information.

• Part (7), has a label that purports that it was produced in a manner that follows a standard 

of identity, but the product does not conform to those standards.

• Part (8), does the amount of product in the container fall below the fill standard.

• Part (9), contains ingredients that are not represented on the label by common names of 

the food.

• Part (10), makes special dietary claims but does not list the corresponding dietary 

properties and information required on the label.

• Part (11), contains artificial flavoring, coloring, or chemical preservatives that are not listed 

on the label.

• Part (12), requires some type of handling for a wholesome condition to be maintained but 

the label fails to contain that information.
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The terms “label” and “labeling” are also defined in the FMIA as follows.

• FMIA 601(o) – The term “label” means a display of written, printed, or graphic matter upon 

the immediate container of any article.

• FMIA 601(p) – The term “labeling” means all labels and other written, printed, or graphic 

matter upon any article or any of its containers or wrappers or accompanying such article.

Section 607 of the FMIA covers labeling, marking, and container requirements. Section 607(e) 

states that when there is reason to believe the marking or labeling or container is false or 

misleading, FSIS has the authority to withhold its use until it is modified so that it is no longer 

false or misleading.

There are similar provisions in the poultry statutes. The Poultry Products Inspection Act (PPIA) 

453 (h) contains similar definitions of “misbranded” and 457 contains labeling and container 

standards.

Labeling & Standards of Identity

There are certain general labeling requirements that apply to all product that bear a label. Some of these 

basic requirements include:

• The label must list the name of the product and ingredients.

• The ingredients statement should be accurate (i.e., that all ingredients are listed in descending 

order of predominance and any proteinaceous substances used in the formulation are declared in 

the ingredients statement).

• The name and place of business of the manufacturer must be shown.

• It must contain an accurate statement of the net weight or quantity.

• The label must not be false or misleading.

• It must list any handling (refrigeration) of the product that is required in order to maintain the 

product in a wholesome condition.

• There are also very specific requirements for safe handling instructions for raw or not ready-to-eat 

meat and meat products.

• Restricted ingredients (if any) are used as per regulatory requirements.

• The label is used on appropriate product.

• There is a label approval on file.

The term Standard of Identity, however, refers to certain regulatory requirements that must be met in 

order to label specific types of product. These regulations dictate that products for which standards of 

identity exist must have a label showing the product name and ingredients statement and any other 

information as listed in the standard of identity regulations.

The 9 CFR 319.15-319.881 (Subparts B through U) cover the specific requirements for various meat 

products – from raw products that have only a few ingredients, to products such as cooked sausage that 

may have a number of ingredients and may go through numerous processing steps.
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Here’s an outline of all the regulations covering the definitions and standards of identity or composition 

(Part 319) for meat products:

Subpart A – General

Subpart B – Raw meat products 

Subpart C – Cooked meats

Subpart D – Cured meat, unsmoked and smoked 

Subpart E – Sausage generally: fresh sausage 

Subpart F – Uncooked, smoked sausage 

Subpart G – Cooked sausage

Subpart K – Luncheon meat, loaves, jellied products 

Subpart L – Meat specialties, puddings, nonspecific loaves 

Subpart M – Canned, frozen, dehydrated meat food products 

Subpart N – Meat food entrée products, pies, and turnovers

Subpart O – Meat snacks, hors d’oeuvres, pizza, and specialty items 

Subpart P – Fats, oils, shortenings

Subpart Q – Meat soups, soup mixes, broths, stocks, extracts 

Subpart R – Meat salads and meat spreads

Subpart U – Miscellaneous (breaded and liver meat products)

9 CFR 381 Subpart P covers the labeling requirements for poultry products that have standards of identity. 

9 CFR 381.156 covers the requirements for using terms such as light or dark meat on a label containing 

poultry products. Like the regulations related to meat products, these regulations covering poultry 

products specify percent of poultry light/dark meat required for the product to meet the standard, and in 

some cases the type of ingredients required/allowed, such as binders or extenders.

Here are the 9 CFR §381 Subpart P regulations covering the standards of identity for poultry products:

381.155 – General

381.156 – Poultry meat content standards for certain poultry products

381.157 – Canned boned poultry and baby or geriatric food

381.158 – Poultry dinners (frozen) and pies

381.159 – Poultry rolls

381.160 – (Kind) burgers; (Kind) patties

381.161 – “(Kind) A La Kiev”

381.162 – “(Kind) steak or fillet”

381.163 – “(Kind) baked” or “(Kind) roasted”

381.164 – “(Kind) barbecued”

381.165 – “(Kind) barbecued prepared with moist heat

381.166 – Breaded products

381.167 – Other poultry dishes and specialty items

381.168 – Maximum percent of skin in certain poultry products

381.169 – Ready-to-cook poultry products to which solutions are added

381.170 – Standards for kind and classes, and for cuts of raw poultry

381.171 – Definitions and standards for “Turkey Ham”

381.173 – Mechanically Separated (Kind of Poultry)

381.174 – Limitations with respect to use of Mechanically Separated (Kind of Poultry)
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Verification Methodology for Non-Food Safety Tasks

FSIS Directive 7000.1 provides general instructions for how IPP are to perform specific 

verification tasks related to non-food safety requirements. The PHIS system will assign other 

consumer protection tasks to establishment task lists based on the product information recorded 

in the establishment profile. As with other tasks, IPP are to schedule the tasks on the dates 

most appropriate for performing the particular verification task.

The NFSCP Tasks include the Economic/Labeling Tasks, Labeling Tasks, Livestock Finished Product 

Standards Task, Poultry Finished Product Standards Task, Economic Sampling Task, and Species 

Specific Sampling Tasks. IPP will perform the appropriate verification procedures by:

• Observing establishment product formulation;

• Verifying the accuracy of labeling;

• Observing processing procedures;

• Reviewing establishment records;

• Examining product;

• Checking product identification, condition and temperature;

• Performing a variety of other in-plant measurements, testing and calculations; or

• Observing slaughter practices.

Product compliance determinations are made based on non-food safety regulatory requirements, 

including product standards, net weight standards, regulatory minimum or maximum limits of ingredients 

or components, or product defects. If product is found to exceed any of the maximum limits, falls below 

the minimum requirements, or fails to meet any of the other regulatory requirements, there is 

noncompliance. As mentioned before, determinations of noncompliance should be based on production 

lots or process controls rather than on individual units of product.

When noncompliance is found, take the appropriate regulatory control actions, such as retention of 

product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of 

specifically identified product (9 CFR 500.1(a)), if it is determined that misbranded or economically 

adulterated product would otherwise enter commerce or be shipped from the establishment. Additionally, 

FSIS may rescind or refuse approval of false or misleading marks, labels, or sizes, or forms of any 

container for use with any meat or poultry product per 9 CFR 500.8. If it is determined that economically 

adulterated or misbranded product has entered commerce, FSIS will expect establishments to implement 

recall procedures.
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RULES OF PRACTICE

ROP

500.1 Definitions

500.2 Regulatory control action

500.3 Withholding/Suspension WITHOUT prior notification 

500.5(a) Notification

500.4 Withholding/Suspension WITH prior notification 

500.5(b) Notification

500.6 Withdrawal

500.7 Refusal to grant inspection

500.8 Rescinding labels, marks

HAZARD ANALYSIS CRITICAL CONTROL POINT

HACCP

417.1 Definitions

417.2 Hazard Analysis and HACCP Plan

(a) Hazard analysis

(1) Determine RLTO hazards, identify preventive 

measures

(2) Flow chart

(3) Expected food safety hazards

(b) HACCP plan

(1) develop and implement for each 

process/product, if hazard RLTO

(2) requirements for single HACCP Plan

(3) requirements for thermally processed

(c) Contents of HACCP Plan

(1) List of food safety hazards

(2) List of CCP’s

(3) List of critical limits

(4) List of procedures & frequency

(5) Corrective actions

(6) Record keeping system

(7) List of verification procedures/frequency

(d) Signing and dating HACCP plan

(1) Signed and dated by responsible person

(2) Sign and date frequency

(e) Failure to Develop and Implement HACCP Plan

417.3 Corrective Actions

(a) Describe action after deviation

(1) Cause is identified & eliminated

(2) CCP is under control

(3) Prevent recurrence

(4) No adulterated product shipped

(b) Unforeseen hazard

(1) Segregate, hold product

(2) Perform review

(3) Actions to ensure product not shipped

(4) Reassessment of HACCP plan

(c) Document corrective actions

417.4 Validation, Verification, Reassessment

(a) Every establishment shall validate HACCP plan/s

(1) Initial validation

(2) Ongoing verification to include, (i) calibration

(ii) direct observation (iii) review of records

(3) Reassessment, (i) at least annually or when 

change is made, (ii) record reassessment

(b) Reassessment of hazard analysis

417.5 Records

(a) Establishment shall maintain

(1) Written hazard analysis

(2) Written HACCP plan

(3) Records of CCP’s, temps., corrective actions

(b) Made at time event occurs

(c) Pre-shipment review

(d) Records on computer

(e) Record retention

(f) Official review

417.6 Inadequate HACCP System

(a) Plan doesn’t meet requirements

(b) HACCP tasks not accomplished

(c) Fails to take corrective actions

(d) No records

(e) Adulterated product shipped

417.7 Training

(a) Trained individual develops/reassesses

(b) Course of instruction

417.8 Agency Verification

(a) Review HACCP plan/s

(b) Review CCP records

(c) Review adequacy of corrective actions

(d) Review critical limits

(e) Review other records pertaining to HACCP plan/s

(f) Direct observation of CCP

(g) Sample collection

(h) On-site observation & records review

SANITATION PERFORMANCE STANDARDS

SPS

416.1 General rules

416.2 Establishment grounds and facilities

(a) Grounds and pest control

(b) Construction

(c) Light

(d) Ventilation

(e) Plumbing

(f) Sewage disposal

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

(h) Dressing rooms, lavatories & toilets

416.3 Equipment and utensils

(a) constructed to facilitate cleaning

(b) accessibility for inspection

(c) receptacles for storing inedible material

416.4 Sanitary operations

(a) food contact surface, cleaning & sanitizing

(b) non-food contact surface, cleaning & sanitizing

(c) cleaning compounds and sanitizers

(d) product protected

416.5 Employee Hygiene

(a) Cleanliness

(b) Clothing

(c) Disease control

416.6 Tagging equipment, rooms or compartments

SANITATION STANDARD OPERATING PROCEDURES

SSOP

416.11 General Information

416.12 Development of SSOP’s

(a) describe all procedures

(b) signed and dated

(c) procedures for pre-op

(d) frequency of procedures & responsible 

individual

416.13 Implementation of SSOP’s

(a) conduct pre-op

(b) conduct all other procedures

(c) monitors implementation of SSOP procedures

416.14 Maintenance of SSOP’s routinely evaluate

416.15 Corrective Actions

(a) conduct corrective actions, including

(b) disposition of contaminated product 

restore sanitary conditions

prevent recurrence

416.16 Record Requirements

(a) daily records required, responsible individual, 

initialed and dated

(b) records on computers

(c) location and retention of records maintained

416.17 Agency Verification

review SSOP’s, daily records, direct observation of SSOP 

procedures & direct observation of testing

RECALL

418.2 Notification

418.3 Preparation and maintenance of written procedures

418.4 Records

10-8-15
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Additional Resources

Acronym Listing

AA AssistantAdministrator 

ACS AcidifiedCalcium Sulfate

ADR Animal Disposition Reporting

AER Administrative Enforcement Report 

AM Antemortem Inspection

AMA Antimicrobial Agent

AMAP Antimicrobial Agents and Processes 

AMP Antimicrobial Process

AMS Agricultural Marketing Service

AOAC AssociationofOfficial Analytical Chemists(Now calledAOAC International) 

APC Aerobic Plant Count

APHIS Animal andPlant Health Inspection Service 

AMR Advanced Meat Recovery

ASC Acidified Sodium Chlorite 

ATP Adenosine Triphosphate aw

Water Activity

BITES Biological Information Transfer Email System 

BSE Bovine Spongiform Encephalopathy

CA Corrective Actions

CCMS Consumer Complaint Monitoring System 

CCP Critical Control Point

CDC CentersforDisease Controland Prevention 

CFL Center for Learning

CFR Codeof Federal Regulations 

CFU Colony Forming Units

CIP Clean in Place

CL Critical Limit

COA Certificate of Analysis 

CPS Coagulase Positive Staph

CSI Consumer Safety Inspector 

CSO Consumer Safety Officer 

DM District Manager

DDM DeputyDistrictManager 

DCS District Case Specialist

DJE DualJurisdiction Establishment 

DO District Office

DRO District Recall Officer

DVMS District Veterinary Medical Specialist

EARO Executive Associate for Regulatory Operations 

EIAO Enforcement Investigations and AnalysisOfficer 

EMC Emergency Management Committee

EPA Environmental Protection Agency 

EPIA Egg Products Inspection Act
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FCS Food Contact Surface

FDA Food and Drug Administration

FDIB FoodborneDisease InvestigationBranch 

FFDCA Federal Food, Drug, and Cosmetic Act

FI Food Inspector

FIFRA Federal Insecticide Fungicide and Rodenticide Act 

FLS Frontline Supervisor

FMIA Federal Meat Inspection Act 

FNS Food and Nutrition Service 

FO Field Operations

FOIA FreedomofInformation Act 

FPS Finished Product Standard 

FR Federal Register

FSA Food Safety Assessment

FSIS Food Safety and Inspection Service 

GAD Gather Assess Determine

GMP Good Manufacturing Practice 

GRAS Generally Recognized as Safe 

HA Hazard Analysis

HACCP Hazard Analysis and Critical Control Point 

HATS Humane Activities Tracking System

HAV Hazard Analysis Verification 

HCG Hazards Control Guide

HEP High Event Period (with regard to STECs) 

HH Humane Handling

HIMP HACCP-basedInspectionModels Project 

HMSA Humane Methods of Slaughter Act

HPP High Pressure Processing

HRI Hotels,Restaurants, and Institutions 

HUS Hemolytic Uremic Syndrome

ICMSF International Commission on the Microbiological Specification for Foods 

IIC Inspector in Charge

IKE Interactive Knowledge Exchange 

IPP Inspection Program Personnel 

IVT Intensified Verification Testing 

KIS Kidney Inhibition Swab

LIMS Laboratory InformationManagement SystemDirect 

Lm Listeriamonocytogenes

LOG Letter of Guarantee LOI

Letter of Information LOW 

Letter of Warning

LPDS Labeling and Program Delivery Staff 

LTD Less Than Daily

MOI Memorandum of Interview 

MOU MemorandumofUnderstanding

MPCM Microbial PathogenComputerModeling 

MPN Most Probable Number

MPR Moisture Protein Ratio
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NACMCF National Advisory Committee on the Microbiological Criteria for Foods 

NACMPI National Advisory Committee on Meat and Poultry Inspection

NFCS Non Food Contact Surface

NFSCP Non-Food Safety Consumer Protection

NIST National Institute of Standards andTechnology 

NOIE Notice of Intended Enforcement

NOL No Objection Letter 

NOS NoticeofSuspension

NPDW National Primary DrinkingWater 

NR Noncompliance Record

NRLTO Not Reasonably Likely toOccur 

NRTE Not Ready to Eat

OCP Other Consumer Protection 

OFO Office of Field Operations 

OIG Office of InspectorGeneral 

OM Office of Management

OEED Office of Employee Experience and Development 

OPACE Office of Public Affairs and Consumer Education 

OPARM Office of Planning,Analysis, and Risk Management 

OIEA Office of Investigation, Enforcement, and Audit 

OPHS Office of Public Health Science

OPPD Office of Policy and Program Development

OSHA Occupational Safety andHealth Administration/Act 

PDS Policy Development Staff

PFGE Pulsed Field Gel Electrophoresis 

PHV Public Health Veterinarian

PHIS PublicHealth InformationSystem 

PLE Post Lethality Exposed

PLT Post Lethality Treatment 

PM Postmortem Inspection

PMP Pathogen Modeling Program 

PMP Pest Management Program 

PPIA Poultry ProductsInspectionAct 

PPM Parts Per Million

PR Pathogen Reduction 

PRP Pre-Requisite Program

QA Quality Assurance

QC Quality Control

QRG Quick Reference Guide 

RCA Regulatory ControlAction 

RD Regional Director (OIEA) 

REC Recall Effectiveness Check

RMIS Risk Management and Innovation Staff 

RLm Risk Based Listeriamonocytogenes Testing 

RLTO Reasonably Likely to Occur

RMA Resource Management Analyst 

RMS Resource Management Specialist

RMTAD Recall Management and Technical Analysis Division
238

ROP RulesofPractice 

RTE Ready to Eat

RTE/SS Ready to Eat/Shelf Stable

SCSI Supervisory Consumer Safety Inspector

SEIAO Supervisory EnforcementInvestigations and Analysis Officer 

SIP Salmonella Initiative Program

SOP Standard Operating Procedures

SPC StatisticalProcessControlor StandardPlate Count 

SPHV Supervisory Public Health Veterinarian

SPS Sanitation Performance Standards 

SRM Specified Risk Materials

SSOP SanitationStandardOperatingProcedures 

STEC Shiga toxin-producing E. coli

STEPS System Tracking E. coli Positive Suppliers 

SVMO Supervisory Veterinary Medical Officer 

TA Talmadge-Aiken Act

TCOE Training as a Condition of Employment 

TDT Thermal Death Time

TPC Total Plate Count 

TSP TrisodiumPhosphate 

TT Time Temperature 

USC United States Code

USDA United States Department of Agriculture 

vCJD Variant Creutzfeldt-Jakob disease

VMO Veterinary MedicalOfficer 

VP VerificationPlan
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