Sanitation Performance Standards 

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Sanitation Performance Standards 

OBJECTIVES 

To demonstrate mastery of Sanitation Performance Standards (SPS), the trainee 

will: 

1.	 Describe the relationship between establishment sanitation and the 

cleanliness and wholesomeness of product. 

2.	 Identify two sources of authority for performing sanitation inspection. 

3.	 Define “sanitation”. 

4.	 Define “performance standard” as it relates to sanitation. 

5.	 Describe the relationship between SPS and Sanitation Standard Operating 

Procedures (SSOP). 

6.	 Identify the task performed to verify establishment compliance with SPS. 

7.	 List the two activities used to verify compliance with the SPS. 

8.	 Identify when it is appropriate to cite noncompliance with 9 CFR 416.1. 

9.	 For a given scenario, identify if there is regulatory noncompliance and the 

SPS regulation that was not met. 

10.Describe the documents that are required by the SPS regulations. 

11.Describe what differentiates SPS noncompliance from SSOP or HACCP 

noncompliance. 

12.Describe appropriate enforcement actions when SPS regulatory requirements 

are not met. 

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Sanitation Performance Standards 

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INTRODUCTION 

Overview 

Proper and effective sanitation is vital to every step of a food manufacturing 

process. The wholesomeness of product is directly dependent on the sanitary 

practices conducted in the food production operation. Insanitary facilities and 

equipment, poor food handling, improper personal hygiene, and similar insanitary 

practices create an environment conducive to contamination of products. There 

are direct links between inadequate sanitation and the contamination of meat and 

poultry products with pathogenic bacteria. 

Sanitation is broadly defined as the formulation and application of procedures that 

establish an environmental state that promotes cleanliness and protects public 

health. It has many implications when applied to the food-processing environment. 

A safe water supply and distribution system, unpolluted air, sound construction of 

facilities; effective vermin control; and proper waste handling, disposal, and 

treatment are critical elements of environmental sanitation. Effective environmental 

sanitation or cleanliness coupled with sanitary maintenance of equipment and 

utensils, good personal hygiene, and proper food handling practices substantially 

reduce the risk of direct product contamination and adulteration and are essential to 

the implementation of Hazard Analysis and Critical Control Point (HACCP) systems. 

Inspected establishments must meet two sets of regulations concerning 

sanitation: The Sanitation Standard Operating Procedures (SSOP) 

requirements and the Sanitation Performance Standards (SPS). Compliance with 

both is necessary if an establishment is to prevent the creation of insanitary 

conditions that can cause the adulteration of product. Under the SSOP 

requirements, each establishment must develop, implement, and maintain written 

procedures for the procedures it conducts daily, before and during operations, to 

prevent product from direct contamination and adulteration. SSOP requirements 

are in the next training module. 

Most of the SPS address conditions within and around the establishment (e.g., 

ventilation, lighting, facility and equipment construction, and maintenance of the 

grounds). A few address establishment operations and may be met through the 

establishment’s SSOP (e.g., cleaning and sanitizing food contact surfaces) or its 

HACCP plan (e.g., water reuse). SPS are an integral part of the overall public 

health picture of a facility or establishment. In combination with SSOP 

requirements, they ensure that products are produced in a sanitary environment. 

SPS carry as much regulatory weight and enforceability as any other part 

of FSIS’s regulatory food safety system. The enforcement strategy, 

however, is different. 

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The SPS rule requires the following businesses to operate in a sanitary 

environment: 

 Federal and State inspected meat and poultry establishments 

 Import/Export facilities 

 Identification (ID) warehouses 

 Custom-exempt operations 

Definition of Performance Standard 

Performance standards set the results to be achieved, but they do not prescribe 

the step-by-step procedures to produce safe meat and poultry products. Simply 

put, the expected result is defined in the regulation, but the methods to achieve 

that result are not specified. The performance standards allow establishments 

the flexibility to develop and employ innovative and unique sanitation procedures 

to achieve the desired results. Although establishments can use varying means 

to meet the performance standards, the required results are always the same. 

Establishments must: (1) operate under sanitary conditions, (2) ensure 

product is not adulterated, and (3) operate in a manner that does not 

interfere with FSIS inspection and enforcement of the standards. 

AUTHORITY 

Proper sanitation is a fundamental requirement of the federal meat and poultry 

inspection laws that the Agency enforces. The Federal Meat Inspection Act 

(FMIA) and Poultry Products Inspection Act (PPIA) provide authority, 

requirements, policies, and standards related to sanitation. The law is quite 

clear: meat and poultry products produced, packed, or held under 

insanitary conditions where they may have become contaminated with filth 

or may have been rendered injurious to health are deemed adulterated, 

without any further showing required by FSIS. 

FSIS requirements for sanitation are found in the following regulations. 

 Part 307, sections 307.1-3 

 Part 381, subpart G, and 

 Part 416, section 416.1-416.6 

Specific instructions on how to verify sanitation in an establishment are found in 

FSIS Directive 5000.1 Rev. 4 

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IPP RESPONSIBILITY 

IPP will perform routine or directed SPS Verification tasks to determine whether 

establishments meet all of the SPS regulatory requirements. IPP will schedule 

routine sanitation verification tasks in the PHIS by selecting them from the task 

list and placing them on their task calendar. Directed tasks are those other than 

routine. IPP may schedule them when IPP observe SPS noncompliance during 

the performance of other tasks or when IPP suspect noncompliance with any of 

the sanitation performance standards. Verification of the SPS requirements may 

include direct observation of conditions in the establishment and observing 

establishment employees or review of establishment documents. 

Documentation Review 

For the most part, establishments are not required to develop, generate, or 

maintain daily records that document compliance with SPS. For some of the 

sanitation performance standards, however, they are required to maintain and 

provide specific written documents for review. §416.4(c) requires an 

establishment to have “documentation substantiating the safety of a chemical’s 

use in a food processing environment.” §416.2(g) (1) requires an establishment 

to have water potability certificate. §416.2(f) requires an establishment to have a 

sewage disposal letter when the establishment’s system is private. 

Any documentation required to meet a particular sanitation performance standard 

will be identified when that performance standard is discussed in this module. 

 If the establishment’s SSOP contains procedures it uses to meet SPS 

regulations (e.g., cleaning and sanitizing of food contact surfaces), then the 

records associated with those procedures must meet the recordkeeping 

requirements for SSOPs in §416.16. 

 The establishment’s hazard analysis, HACCP plan, or SSOP references, 

procedures or prerequisite programs it uses to meet the SPS regulations, the 

records associated with those procedures must be available to FSIS. Such 

records do not have to meet the recordkeeping requirements for SSOPs in 

§416.16, but must contain ongoing documentation that continues to 

substantiate the establishment’s decision in the hazard analysis, HACCP 

plan, or SSOP. 

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Direct Observations 

In general, IPP will verify compliance with the SPS regulations by directly 

observing the conditions in the establishment and observing establishment 

employees. IPP determine which sanitation performance standard or standards 

to verify. They choose from those listed in the regulations. When time allows, 

IPP are to verify multiple SPS regulatory requirements in multiple areas of the 

establishment each time they perform the SPS verification task. In many cases, 

IPP will be able to verify one or more SPS requirements while observing the 

establishment during other verification activities. IPP must use professional 

knowledge and good judgment in making the determination whether the SPS 

requirements are met. IPP must assess the situation in the establishment by 

considering what is known for a fact and what is reasonable to conclude, and 

then make the determination whether or not the situation creates insanitary 

conditions, causes adulteration of product, or prevents FSIS from performing 

inspection. 

When IPP determine that the establishment has failed to meet the SPS, IPP also 

evaluate what is known for a fact and determine if the establishment has also 

failed to meet the SSOP and/or HACCP requirements. If the establishment is not 

meeting the regulatory requirements, IPP must document how the establishment 

is not meeting the regulatory requirements in PHIS and initiate the appropriate 

regulatory control actions to gain regulatory compliance. 

At times, there can be conditions in the establishment that are less than perfect 

but do not represent noncompliance with the SPS regulatory requirements 

because they are not creating insanitary conditions, adulterating product, or 

interfering with FSIS inspection activities. 

If IPP determine that the establishment is meeting the sanitation regulatory 

requirements in a particular area of the establishment, IPP should document 

those findings of compliance in the PHIS. The SPS verification task should be 

documented as completed in PHIS. This does not mean that all sanitation 

requirements have been met in the entire establishment; it only means that the 

requirements verified were met in that specific area at the time the task was 

performed. 

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SPS Verification Task Methodology
 

YES 

YES 

NO 

Assess the information 

Has an insanitary condition 

been created? 

NO 

Noncompliance with the 

appropriate SPS regulations 

Gather information by asking questions 

Refer to FSIS PHIS Directive 5000.1 

Verify the regulatory requirements by 

reviewing documentation and/or observing 

establishment conditions 

Using a logical 

thought process to 

arrive at a sound 

supportable 

conclusion 

Compliance with the SPS 

regulations 

NO 

Is product and/or food contact surfaces 

being contaminated or adulterated? 

YES 

Is a food safety hazard 

involved? 

Noncompliance with the 

appropriate SSOP regulations 

Noncompliance with the 

appropriate HACCP regulations 

Select one or more SPS 

regulatory requirements 

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SPS REGULATIONS Workshop #1 

Circle the letter in front of the correct answer for each question. 

1. The SPS requirements are found in 9 CFR Part: 

a.	 301. 

b.	 319. 

c.	 416. 

d.	 417. 

2. Which statement best describes SPS regulations? 

a.	 They contain highly prescriptive sanitation requirements. 

b.	 They prescribe the step-by-step methods or means of achieving defined 

sanitation requirements. 

c.	 They provide the establishment with minimum flexibility to be innovative in 

sanitary facility design, construction, and operations. 

d.	 They define the expected sanitation results, but do not prescribe the 

methods or means to achieve those sanitation results. 

3. The verification task for verifying compliance with the SPS regulations has two 

parts. Which of the following is not one of those parts? 

a. Interviewing establishment production line employees. 

b. Reviewing specific establishment documentation. 

c. Directly observing conditions in the establishment. 

4. The establishment must generate and maintain daily records sufficient to 

document compliance with the SPS regulations. 

a. True. 

b. False. 

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5.	 When the IPP perform the routine SPS verification task, he or she should 

verify: 

a. That all of the requirements in the SPS regulations are met in the
 

establishment.
 

b. That the requirements in at least five of SPS regulations are met in the 

establishment 

c. That the requirements for the selected SPS regulations are met in one or 

more areas of the establishment. 

SANITATION PERFORMANCE STANDARDS 

Note: Regulatory citations appear in Bold Italics. 

The sanitation performance standards identified in §416.1-416.5 focus on 

specific areas or conditions in and around the establishment that may result in 

insanitary conditions that could lead to the adulteration of product. These 

regulations provide the sanitation standards the establishment must meet for the 

mark of inspection to be applied to its products. Insanitary means “a state, 

condition, or occurrence which may lead to the contamination or adulteration of 

edible meat or poultry product when it is exposed, processed, handled, stored, or 

packaged”. Noncompliance involves “insanitary conditions” that do not result in 

direct contamination or adulteration of product. 

Note: The term “adulterated” is defined in §301.2 and §381.1. 

**************************************************************************************** 

§416.1 General Rules 

Each official establishment must be operated and maintained in a manner 

sufficient to prevent the creation of insanitary conditions and to ensure 

that product is not adulterated. 

This regulation sets the overall requirement for all of the sanitation performance 

standards. Establishments must ensure that conditions in and around the plant 

do not lead to adulterated product. 

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

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establishment systematically fails to maintain sanitary conditions, and that 

product adulteration may occur as a result. 

**************************************************************************************** 

§416.2 Establishment grounds and facilities 

This sanitation performance standard regulation covers grounds and pest control; 

construction; light; ventilation; plumbing; sewage disposal; water supply and 

water; ice and solution reuse; and dressing rooms, lavatories, and toilets. 

§416.2(a) Grounds and pest control 

Proper maintenance of the grounds about an establishment is essential for 

ensuring good sanitation. Establishments need to keep the outside premises of 

the establishment clean, orderly, and free from the basic essentials of life (i.e., 

food, water, and a place to hide and rear young) that attract and sustain a 

population of insects, rodents, or birds. The objective is to keep the official 

premises of the establishment so well maintained that pests will seek sustenance 

elsewhere. The best internal pest management program cannot be effective 

when a ready supply of vermin is present just outside the establishment doors! 

§416.2(a) The grounds about an establishment must be maintained to 

prevent conditions that could lead to insanitary conditions, adulteration of 

product, or interfere with inspection by FSIS program employees. 

Establishments must have in place a pest management program to prevent 

the harborage and breeding of pests on the grounds and within 

establishment facilities. Pest control substances used must be safe and 

effective under the conditions of use and not be applied or stored in a 

manner that will result in the adulteration of product or the creation of 

insanitary conditions. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

 The outside premises of the establishment are maintained in a manner that 

does not lead to the creation of insanitary conditions or interfere with FSIS 

inspection. 

 Sources of product contamination or adulteration are prevented even if the 

source originates from outside the establishment’s “official premises.” For 

example, the establishment must prevent objectionable odors, smoke, flying 

ash, etc., even when it is coming from neighboring industries such as oil 

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refineries, paper pulp mills, chemical establishments, etc., from adulterating 

product. 

Note: The “official premises” are the boundaries of the establishment and the 

limit of the IPP’s inspection responsibilities. The establishment is required to 

designate the official premises of the establishment. The IPP may ask for written 

documentation of the boundaries to facilitate inspection of the establishment. 

 A pest control management program is implemented and maintained to 

prevent and/or eliminate pest harborage and breeding on the outside grounds 

and within the establishment. 

Note: Pests can transmit several diseases to humans through food 

contamination. 

Therefore, their presence in or around a food establishment creates an insanitary 

condition! Meat and poultry products should not be contaminated or adulterated 

through the misuse of pest control substances. 

Note: Pest control substances are pesticide chemicals (insecticides, 

rodenticides, or avicides) used to eliminate insects, rodents, and birds, and 

repellents used to keep them away. 

All pest control substances are safe for their intended use and applied, handled, 

and stored to prevent the creation of insanitary conditions that could lead to 

adulterated product. Pesticides, repellents, traps, and other devices must be 

used in a manner that will kill, capture, or repel pests that venture onto the 

premises or gain entrance to the establishment without contaminating product, 

product containers, or equipment. 

Documentation substantiating safe use of a pest control substance in a food 

processing environment is available for FSIS review. 

The Environmental Protection Agency (EPA) requirements under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) are followed. 

FIFRA addresses the application of pesticides and the safety of chemicals. 

►Safety Documentation 

The regulations require that documentation substantiating the safety of a 

chemical’s use, including a pesticide, in a food processing environment be made 

available to the IPP for review [§416.4(c)]. This documentation can vary with the 

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nature and intended use of that chemical. 

Some chemicals must meet certain requirements set forth by other Federal 

Agencies. For example, pesticides have to meet the requirements under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) administered by the 

Environmental Protection Agency (EPA). EPA requires pesticides to be 

registered with EPA, labeled as such, and used only for their intended purpose 

in accordance with their use instructions and safety precautions pertinent to 

their use. 

The documentation in this case would include proof of EPA registration and 

could include labels, application instructions, safety precautions, and other 

information such as records of use. IPP may see documentation in the form of a 

statement that the chemical was previously approved by FSIS and listed in the 

old USDA List of Proprietary Substances and Nonfood Compounds Book. IPP 

can accept this statement as proof that the chemical and its use are safe as long 

as the chemical’s formulation and use has not changed since the book was 

printed. 

►EPA Registered Label 

The EPA registered pesticide label is a legal document that is numbered, 

indicates that the pesticide is a “restricted use” pesticide if it is, and lists the 

target pest, the effective concentration, the permitted conditions of use (food or 

nonfood areas), application methods and directions, and any safety precautions. 

►Restricted Use and General Use Pesticides 

The EPA classifies pesticides as “restricted use” and “general use” compounds. 

General use pesticides are nonresidual (contact or knockdown) pesticides that 

may be prepared, mixed, and used by any representative of the official 

establishment or its contracted pest control company. Contact or knockdown 

insecticides produce rapid results but must directly contact the insect to be 

effective. 

Restricted use pesticides are residual pesticides that may not be purchased by 

the general public. They are restricted to specific uses and application 

methods. These pesticides are more hazardous and may be prepared, mixed, 

and used only by, or under the supervision of, certified applicators. Such persons 

must comply with State and EPA requirements. Residual pesticides are liquid or 

wetted powder insecticides that are sprayed on or applied to surfaces that 

insects contact. They can kill for several hours or longer after application 

because a toxic residue remains on the treated surface for a period of time. 

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Insecticide and rodenticide baits, powders and pellets are also residual 

pesticides. 

►Pesticide Application Methods 

There are several methods of applying liquid spray or aerosol insecticides. 

	 General surface treatment—Applying a liquid spray insecticide to hit the 

individual insect or treat specific surfaces such as floor-wall junctions or 

baseboards 

	 Spot Treatment—A variation of general surface treatment in which a residual 

insecticide is applied in a small secluded site (e.g., electrical panels, motor 

housings, and legs of lockers) that precludes any opportunity for transfer of 

the insecticide to employees, their clothing, hand tools, or any other transfer 

vehicle that may result in product contamination. 

	 Crack and Crevice Treatment—A more restrictive method of general 

surface treatment that involves delivering small amounts of insecticide deep 

into cracks where insects enter the building or crevices where insects may 

hide throughout the establishment. The application of residual 

insecticides in edible product areas, including areas where exposed edible 

product is stored, such as a cooler, or its packaging material is stored is 

usually limited to crack and crevice treatment. The cracks should be 

effectively sealed to prevent further insect traffic after the insecticide becomes 

ineffective. 

	 Space Treatment—The dispersal of insecticides into the air of a specific 

space/room by foggers, misters, or aerosol devices. Residual insecticides 

cannot be used for space treatment of edible product areas, including areas 

where exposed edible product, the equipment used to produce it, or its 

packaging material is stored and areas such as welfare facilities where 

employees may transfer the insecticide to product. 

	 Void Treatment—A variation of space treatment where an insecticide is 

dispersed into a void (such as a hollow wall) by foggers, misters, or aerosol 

devices. 

►Verifying Compliance with this Regulation 

First, IPP need to determine if the establishment has incorporated procedures 

into its SSOP that meet the regulatory requirements for this section of the 

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sanitation regulations. For example, an establishment may include its pest 

management program in the SSOP. When the establishment has included 

procedures for controlling pests and for the safety, conditions of use, application, 

and storage of pest control substances in the SSOP, management must 

implement and monitor such procedures and document the monitoring results 

including any corrective actions taken on the SSOP records. In such cases, IPP 

determine compliance with the regulatory requirements while performing the 

SSOP verification tasks. 

If the pest management program is not in the establishment’s SSOP, then IPP 

need to determine whether or not it is in a written format. The pest management 

program does not have to be written, but if it is, the establishment should follow 

these written procedures. The verification methodology is different when the pest 

management program is not part of the establishment’s SSOP or when the 

establishment does not have written pest control. 

Outside premises and pest control program verification 

IPP should examine and assess the outside premises of the establishment and 

the establishment’s pest control system in one or more places within the 

establishment. IPP should verify the outside grounds are maintained in a 

sanitary manner, there are no areas where pest can breed, live, or hide outside 

or inside the establishment, and there is no evidence of pest infestation outside 

or inside the establishment. 

1. IPP May Gather Information by Seeking the Answer to the Following 

Questions: 

Are all outside areas on the official premises maintained in a manner to 

prevent harborage and breeding of pests? 

Are all areas within the establishment maintained in a manner to prevent 

harborage and breeding of pests? 

Does the establishment have a pest management program? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for objectionable odors and flying dust, smoke, and ash in the air 

outside the establishment. 

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Sanitation Performance Standards 

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Note: Meat and poultry products may be exposed to airborne contaminants that 

can enter the establishment through necessary openings such as loading and 

receiving docks, employee and visitor entrances and exits, etc. 

	 Look for accumulations of trash, debris, board piles, scrap metal, old 

equipment, or other refuse lying around outside the establishment or useful 

materials and equipment stored in direct contact with the ground outside the 

establishment for several days. 

	 Look for tall or overgrown vegetation. 

Note: Accumulations of rubbish, equipment stored on the ground, and tall 

weeds and dense grass are potential homes and hiding places for rodents 

and other vermin. 

	 Look for accumulations of hog hair, bones, viscera, paunch contents, 

feathers, manure, and other inedible materials in inedible operating and 

storage rooms and outside the establishment on shipping docks, near 

dumpsters, or in live-bird areas, driveways, pens, alleys, etc. 

Note: These organic waste products contain most of the contaminants, diseaseproducing, and spoilage microorganisms from establishment production 

processes. If not handled properly, they can produce objectionable odors, serve 

as fly-breeding materials, and attract rodents and other vermin. 

	 Look for low areas with standing water outside the establishment. 

Note: Surface and run-off water are usually heavily contaminated. Stagnant 

water in pools or puddles can emit offensive odors, serve as a breeding place for 

insects, and a source of water for rodents and other vermin. 

	 Look for conditions inside and outside that interfere with inspection, e.g., 

inaccessible storage rooms or buildings on the official premises; no 

passageways or aisles between rows of supplies, boxes, and ingredients; or 

rows of supplies, boxes, and ingredients stored too close to the wall or stored 

in a manner that the entire floor-wall junction is not visible for detecting pest 

activity in dry storage areas, etc. 

	 Look for indications that the establishment has a pest management program 

in place, e.g., an outside pest extermination firm has serviced the 

establishment, rodent bait stations and glue boards are used in the dry 

storage and inedible areas, holes are sealed around pipes and electrical 

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conduits that enter the establishment, or establishment employees inspect 

incoming supplies for the presence of insects, etc. 

 Look for evidence of pest activity “around” and “within” the establishment. 

Note: Evidence of rodent activity might be visual observation, sound, droppings, 

runways and rub marks, nests and burrows, and gnaw marks, while evidence of 

insect activity might be visual observation, egg capsules, and excrement. 

“Around” the establishment would include outside premises and outside buildings 

within the official premises but not connected to the production facility. “Within” 

the establishment would include processing areas, inedible product areas, and 

nonprocessing areas. 

Processing areas are production rooms or production-related areas such as dry 

ingredient storage areas, spice rooms, coolers, packaging material and container 

dry storage areas, or any other areas where meat and poultry product is 

accessible. Nonprocessing areas are electrical rooms, boiler rooms, 

maintenance rooms, welfare facilities, business offices, or similar places. 

Evidence of pest activity in a processing area requires further investigation 

to determine if products, ingredients, or packaging materials have been 

adulterated or contaminated. 

2. Assess the Information. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and seek answers to the following 

questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the outside premises of the establishment or 

the establishment’s pest control system that is creating an insanitary condition, 

there is noncompliance with the requirements of §416.2(a) and IPP should 

document that noncompliance on an NR. If the conditions IPP observed are not 

creating an insanitary condition or adulteration of product, there is no 

noncompliance. 

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Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is an accumulation of pipes, scrap metal, and old equipment lying on 

the ground outside the establishment. 

	 A large inedible product dumpster outside the establishment is emitting an 

objectionable odor. 

	 There are several low areas with standing/stagnant water in them outside the 

establishment. 

	 Several rows of palletized packaging boxes are stored so close to the wall 

that there is no access to view the floor-wall juncture to detect pest activity. 

	 There is evidence of pest activity (e.g., rodent droppings) in a 

nonprocessing area of the establishment (e.g., maintenance room or boiler 

room). 

Pest control substance use, handling, and storage verification 

IPP should observe and assess the use, handling, and storage of pest control 

substances in one or more areas of the establishment and review establishment 

documentation that supports the safety of their use in the food processing area or 

outside the establishment. IPP should verify that pesticide sprays, gases 

(fumigants), powders, pellets, or baits and repellents are handled, stored, and 

used in a manner that does not create insanitary conditions or adulterate product 

and that documentation describing the safe use of the chemical is on file in the 

establishment. 

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Sanitation Performance Standards 

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1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Does the establishment have documentation on file about the safety of 

the pest control substances?
 

Does the documentation on file include how the pest control 

substances are to be used?
 

Are the pest control substances being applied as per the conditions of 

use?
 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for pesticides used around the outside of the establishment or in the 

establishment that are not EPA-registered. 

	 Look for “restricted use” (residual) pesticides being prepared, mixed, or 

applied by a person who is not a certified applicator or under the supervision 

of certified applicator. 

	 Look for pesticides and repellents used in a manner that is inconsistent with 

their label instructions, safety precautions, or conditions of use identified in 

the use documentation on file. 

Note: Some application methods do not allow operations to be conducted during 

treatment. Other methods allow the establishment to be in operation when 

treated but require exposed product to be removed from the treatment area or be 

effectively covered. Some methods of applying pesticides require the 

establishment to thoroughly wash and rinse food-contact surfaces of equipment 

and utensils before reusing them. 

	 Look for evidence of the use of residual insecticides in processing areas or 

areas such as locker rooms, lunchrooms, restrooms, halls, and the inspection 

office that are frequently used by employees whose primary work duties are 

in edible food areas. 

Note: If the establishment keeps pesticide use records on file, IPP could 

compare these records to the documented application methods and precautions 

in the documentation that is on file at the establishment. 

If a residual insecticide is used in an area like a locker room, it could be 

transferred to employees, their work clothing, or other materials and objects that 

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Sanitation Performance Standards 

11-28-2016 

may contact product and indirectly contaminate it. Floor-wall junctions in areas 

with natural barriers such lockers, tables, cabinets, guard rails, and vending 

machines may be spot-treated with a residual pesticide if they will not be 

contacted by employees’ shoes or other objects that could lead to secondary 

transfer of the insecticide to product 

False or drop ceilings in processing areas or employee welfare areas cannot be 

spot/void treated with a residual pesticide unless the establishment can ensure 

that there is no opportunity for the pesticide spray or vapor to drift onto foodcontact surfaces or other objects or materials below that may be contacted by 

employees whose primary work duties are in edible food areas. 

	 Look for pest control substances stored directly above or adjacent to 

(commingled with) food ingredients or product-packaging materials. 

Note: Pesticides are toxic chemicals and if stored in this manner they could 

be mistaken as food additives or soil packaging materials if they happen to 

leak or are spilled. 

	 Look for clear identification (common name of the compound) on containers 

used to store amounts of pest control substances that have been removed 

from their original fully labeled (bulk) container. 

	 Look for documents, e.g., Safety Data Sheets (SDS), letter of guaranty, 

previous USDA acceptance, etc., that support the safety of pest control 

substances applied in the food-processing environment or around the 

establishment and how they are to be used in the establishment. 

2. Assess the Information Gathered by IPP. 

When the establishment has no documentation on file to support the safety of a 

pest control substance that is used in or outside the establishment, there is 

noncompliance with §416.4(c). 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any misuse, mishandling, or improper storage of pest control 

substances, there is noncompliance with the requirements of §416.2(a) and IPP 

Inspection Methods	 11-18 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

should document that noncompliance on an NR. If the conditions IPP observed 

are not creating an insanitary condition or adulteration of product, there is no 

noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 The establishment’s pest extermination company is applying an insecticide in 

a manner that is inconsistent with the instructions on the label. 

	 A two-gallon container of insecticide is stored on a rack next to bags of flour 

in the ingredient dry storage area. 

**************************************************************************************** 

§416.2(b) Construction 

An establishment’s construction, layout (placement of rooms and equipment) and 

product flow can have a significant impact on daily sanitation operations and the 

goal of minimizing or eliminating product contamination. 

The performance standards for construction provide establishments, regardless 

of size, flexibility to design facilities and equipment in the manner to maintain a 

sanitary environment for food production. 

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

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

and be of sufficient size to allow for processing, handling, and storage of 

product in a manner that does not result in product adulteration or the 

creation of insanitary conditions. 

Inspection Methods	 11-19 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Buildings, including the rooms, compartments, coolers, and freezers are of 

such materials, construction, and finish (surface) that permit thorough 

cleaning to prevent insanitary conditions and product adulteration during 

processing, handling and storage. 

	 Rooms, compartments, coolers, freezers, and structures are large enough to 

allow orderly processing, handling, and storage of product. Inadequate room 

size and poor placement of equipment may result in congested operations 

that can lead to insanitary conditions. 

	 The structure of the establishment, its rooms, compartments, coolers, and 

freezers remains in good repair. Neglected or deteriorating facilities can 

defeat even the best sanitation program and lead to insanitary conditions or 

the adulteration of product. 

Note: Floors subject to wet cleaning operations that are not watertight, i.e., have 

cracks, crevices, or holes, allow biological material and moisture to accumulate. 

Organic materials (e.g., protein and fat residue) and moisture caught or stuck in 

cracks or holes in the floor coupled with a prolonged drying time are all important 

factors in microbial growth. 

Walls with rough or uneven surfaces where product is handled are difficult to 

clean because they may have recesses or depressions where protein and fat 

residue and foreign materials can collect. Likewise, junctions at floors and walls 

in production areas that have crevices, open cracks, or separations can allow 

water, dust, debris, and product residue to collect. 

Although ceilings seldom contact product, they are a potential source of product 

contamination if foreign material or moisture drops onto equipment and exposed 

products. Therefore, they should be maintained in good repair and free of 

potential overhead contaminants such as scaling paint or plaster and leaks. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the design and construction of rooms, 

compartments, and structures in one or more areas of the establishment where 

product is processed, handled, and stored. IPP should verify that the room, 

compartment, or structure (door, partition, or post) is made with materials that 

can be cleaned, is of sufficient size, and is maintained in good repair. 

Inspection Methods	 11-20 
 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions: 

Are the rooms and compartments of sufficient size to allow for
 

processing, handling, and storage of product? 

Are the structures, rooms, and compartments kept in good repair? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for doors or doorways too small to permit product transferred on rails or 

in hand-trucks to pass through without contacting the door jamb. 

	 Look for carcass rails without enough passageway space to prevent exposed 

product from contacting walls, refrigeration units, columns, or other fixed parts 

of the building. 

	 Look for inadequate space and capacity in work rooms, freezers, and coolers 

causing congested installation of equipment and storage of product, poor 

product clearance from objects, trash dumpsters stored next to exposed 

product or food-contact surfaces, etc. 

	 Look for breaks, cracks, and holes in the floors, walls, and ceilings of 

production areas and employee welfare facilities. 

	 Look for junctions at floors, walls, and ceilings in production areas and 

employee welfare facilities with open crevices, cracks, or separations. 

	 Look for flaking or peeling paint or plaster on ceilings where product is 

processed, handled, or stored. 

	 Look for leaks in the ceilings of production areas and employee welfare 

facilities when it is raining. 

	 Look for plastic strips in poor repair on doors through which exposed product 

passes. 

2.	 Assess the Information gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

Inspection Methods	 11-21 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the design, construction, and maintenance of 

any room, compartment, or structure in the establishment that is creating an 

insanitary condition, there is noncompliance with the requirements of 

§416.2(b)(1) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 Flaking or peeling paint on the walls or ceilings of edible product areas. 

	 Two holes in the glass board of a wall in an edible product area permitting 

moisture to penetrate the wood behind it. 

	 Open gaps in the drop ceiling of the spice room because two fiberglass 

plastic ceiling panels have warped and are no longer seated correctly on 

metal cross straps. 

	 An exposed gap/separation at the wall-floor juncture in the equipment and 

utensil washroom because two brick tiles that cover it are gone. 

**************************************************************************************** 

§416.2(b)(2) Walls, floors, and ceilings within establishments must be built 

of durable materials impervious to moisture and be cleaned and sanitized 

as necessary to prevent adulteration of product or the creation of 

insanitary conditions. 

Inspection Methods	 11-22 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Floors, walls, and ceilings in areas where product is processed, handled, or 

stored are made of durable, easily cleanable, and moisture-resistant 

materials. Materials that are absorbent like wood, plaster board, and porous 

panels and tiles are difficult to keep clean. 

	 Floors, walls, and ceilings are cleaned at a frequency sufficient to prevent 

insanitary conditions and product adulteration. 

Note: In order to be susceptible to thorough cleaning, the basic building 

materials used in the floors, walls, and ceilings of production and storage areas 

should be easy to clean, rigid, smooth, impervious to moisture, and resistant to 

wear and corrosion. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the materials used to build and the cleanliness 

of the floor, walls, and ceiling of one or more rooms, compartments, and 

structures in the establishment. IPP should verify that the materials used in the 

construction of the floor, wall, and ceiling are durable and nonabsorbent. IPP 

should also verify that the floor, wall, and ceiling have been cleaned and 

sanitized as needed to prevent insanitary conditions. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are the walls, floors, and ceilings made of materials that are durable and 

impervious to moisture? 

Are the walls, floors, and ceilings cleaned and sanitized as necessary? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for the accumulation of dried or encrusted product residue from previous 

days’ production, dust, or debris on floors and walls where product is 

processed, handled, and stored. 

	 Look for floors, walls, and ceilings made with materials that are absorbent in 

areas that are wet-cleaned. 

Inspection Methods	 11-23 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for dust, dirt, and debris on ceilings and window ledges where product is 

processed, handled and stored. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the construction and cleanliness of the floor, 

walls, or ceiling of a room, compartment, or structure in the establishment that is 

creating an insanitary condition, there is noncompliance with the requirements of 

§416.2(b)(2) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is an accumulation of dust on the ceiling around air vents in the fresh 

sausage packaging room. 

	 There are fat particles and hog hair from the previous days’ production on the 

wall behind the dehairing machine. 

**************************************************************************************** 

§416.2(b)(3) Walls, floors, ceilings, doors, windows, and other outside 

openings must be constructed and maintained to prevent the entrance of 

vermin, such as flies, rats, and mice. 

Inspection Methods	 11-24 
 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 The design and construction of the plant creates a barrier that prevents the 

entry of pests from the outside. Some places where pests can gain entry into 

the establishment include gaps or separations in exterior wall-floor, wall 

ceiling, and doorjamb junctures, gaps around service entries (e.g., pipes and 

electrical conduits) through exterior walls, floors, and ceilings, etc. 

	 Breaks in the construction such as holes or cracks in exterior walls are 

promptly repaired. 

	 Doors that open to the outside and windows are protected against the 

entrance of pests or equipped with suitable devices (screens, fans, seals, 

etc.) to keep them out. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the design, construction and maintenance of the 

establishment’s exterior walls, floors, ceilings, outside doors, and other outside 

openings in one or more areas of the establishment. IPP should verify that the 

outer walls, ceilings, and floors prevent the entrance of pests. IPP should also 

verify that outside openings such as doors and windows are equipped with 

suitable devices or barriers to keep insects, birds, and rodents out. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are the walls, floors, ceilings, doors, windows, and other outside 

openings constructed and maintained to prevent the entrance of vermin, 

such as flies, rats, and mice? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for broken areas, holes, cracks, and separations in the exterior walls of 

the establishment. 

	 Look for open or broken windows without devices or barriers to prevent the 

entrance of pests. 

Inspection Methods	 11-25 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for outside doors with gaps around the jambs that remain open (ajar) or 

do not close tightly, or are in poor repair (e.g., have holes in them). 

	 Look for gaps around pipes and electrical conduits entering the building. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the effectiveness of a floor, wall, ceiling, door, 

or establishment opening’s construction or maintenance in excluding pests that is 

creating an insanitary condition, there is noncompliance with the requirements of 

§416.2(b)(3) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 There are open gaps or cracks around several outside doors and pipes 

entering the establishment. 

	 A window without a screen has a broken windowpane. 

	 There is a crack in the exterior block wall of the ingredient storage room. 

Inspection Methods	 11-26 
 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

**************************************************************************************** 

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

handled, or stored must be separate and distinct from rooms or 

compartments in which inedible product is processed, handled, or stored, 

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

insanitary conditions. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that areas where edible 

products are processed, handled, and stored are adequately separated from 

those areas like inedible product departments that could cross-contaminate food 

products with disease-causing microorganisms, chemicals, filth, or other 

extraneous and deleterious materials. 

Note: Establishments can process, handle, or store edible and inedible product 

in the same room as long as they are separated by time or space in a manner 

that prevents adulteration of the edible product or the creation of insanitary 

conditions. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the handling and storage of inedible product. 

IPP should verify inedible products are adequately separated from edible 

products. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are edible products and inedible products processed, handled, and 

stored in a manner that prevents product adulteration and the creation 

of insanitary conditions? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for inedible product containers commingled with edible product in 

coolers. 

	 Look for inedible product contacting edible product. 

	 Look for inadequate separation between the handling of inedible and 

condemned products and edible product. 

Inspection Methods	 11-27 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the handling and storage of inedible product 

that is creating an insanitary condition, there is noncompliance with the 

requirements of §416.2(b)(4) and IPP should document that noncompliance on 

an NR. If the conditions that IPP observed are not creating an insanitary 

condition or adulteration of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 Inedible containers with byproducts to be used as animal or pet food are 

commingled with containers that have edible offal in them in a cooler. 

	 The denaturing or decharacterizing and packing of inedible byproducts and 

the handling and packing of edible offal are in a room too small to keep 

employees and products separated. 

******************************************************************************************** 

§416.2(c) Light 

Adequate lighting is essential to maintain a sanitary environment for slaughter 

and processing operations. Without adequate lighting, insanitary conditions are 

difficult to see and correct. Similarly, contaminants cannot be easily avoided or 

removed if they cannot be seen. 

Inspection Methods	 11-28 
 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

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

sanitary conditions are maintained and that product is not adulterated must 

be provided in areas where food is processed, handled, stored, or 

examined; where equipment and utensils are cleaned; and in hand-washing 

areas, dressing and locker rooms, and toilets. 

►Establishment’s Responsibilities 

The establishment has the responsibility to provide good quality lighting of 

sufficient intensity in production related areas, equipment and utensil washrooms 

or wash areas, hand washing areas, and welfare facilities to ensure that sanitary 

conditions are maintained and that product is not adulterated. 

The establishment will determine which intensities and qualities of light are 

appropriate in different processing environments. The lighting needs to be 

intense enough to allow both establishment and inspection personnel to 

determine that sanitary conditions are maintained and product is not adulterated. 

Note: FSIS has reserved specific lighting requirements of 200 footcandles of 

shadow-free light with a color rendering index of 85 in all poultry establishments 

(except establishments under traditional inspection) at the postmortem inspection 

stations and at reinspection (prechill and postchill) stations (§381.36). A 

minimum of 50 footcandles of shadow-free light is required at the inspection 

surfaces of the head, viscera, and carcass on cattle and swine slaughter lines 

[§307.2(m)(1)]. Since these lighting requirements are not covered under the SPS 

regulation, they are verified using the Inspection & Reprocessing Stations 

requirements. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the quality and intensity of the lighting in 

production related areas, equipment and utensil washrooms or wash areas, hand 

washing areas, or employee welfare rooms in the establishment. IPP should 

verify that the quality and intensity of the lighting is adequate to ensure sanitary 

processing conditions are maintained and to examine product. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are the intensity and quality of lighting adequate for the establishment 

to determine that the products being processed, handled, stored, or 

examined are unadulterated, and that sanitary conditions are 

maintained? 

Inspection Methods	 11-29 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

Are the intensity and quality of lighting adequate for the establishment 

to determine that equipment and utensils are appropriately cleaned? 

Are the intensity and quality of lighting adequate in the handwashing 

areas, dressing and locker rooms, and toilets for the establishment and 

FSIS inspection personnel to determine that sanitary conditions are 

maintained? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for inadequate lighting at the work surface in areas where product is 

processed, handled, stored, or examined. 

	 Look for inadequate lighting in employee welfare areas. 

	 Look for inadequate lighting in areas where equipment and utensils are 

cleaned and inspected for cleanliness. 

	 Look for lighting that distorts the color of the surface of the product. 

2.	 Assess the Information Gathered by IPP. 

If the lighting is inadequate for IPP to determine whether insanitary conditions 

exist, there is noncompliance with these regulatory requirements. 

Note: IPP should realize that there might be less than perfect situations that do 

not constitute noncompliance. If one light is inoperable, but its absence does not 

cause the intensity or quality of the lighting to be inadequate to determine 

whether the products are being processed, handled, stored, or examined under 

sanitary conditions, and thus whether or not the product is adulterated, there is 

no noncompliance. 

Scenario 

You find two inoperable sets of lights over two blenders ready for use in the 

north corner of the sausage kitchen that make the lighting inadequate for you to 

verify that food-contact surfaces are sanitary during pre-op sanitation inspection. 

At this point, you do not know if there is an insanitary condition, but there is 

noncompliance with the requirements of §416.2(c). You take official control of the 

blenders by placing a U.S. reject tag on them. After the establishment repairs 

the lights, you inspect the blenders and find residue from the previous day’s 

production on the mixing arms inside the hoppers. The inadequate lighting may 

Inspection Methods	 11-30 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

have contributed to the establishment’s failure to clean the food-contact surfaces 

of the blenders and the pre-op sanitation monitor’s failure to see the product 

residue in the blenders. You should document all of the noncompliance 

conditions (including the inadequate lighting) on one NR using the PreOperational Sanitation SOP Review and Observation task. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is low lighting in the gizzard-peeling area that prevents an 

establishment worker from inspecting the product. 

	 The lighting at the boneless meat re-inspection area is not adequate to 

determine the wholesomeness of the beef trimmings. 

**************************************************************************************** 

§416.2(d) Ventilation 

A good ventilation system is important to the production of wholesome meat and 

poultry products. Unless the quality of air entering the establishment is controlled 

and the quality of the air in the establishment is maintained, products may 

become contaminated by dust, odors, smoke, fumes, and condensate. A poor 

ventilation system can serve as a vehicle for disseminating microorganisms. 

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

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

of insanitary conditions must be provided. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that the ventilation system: 

	 Provides enough ventilation for all areas of the establishment, including 

processing, packaging, and welfare rooms to control condensation to the 

extent necessary to prevent creation of insanitary conditions and the 

adulteration of product. 

	 Promptly exhausts objectionable vapors (e.g., ammonia), fumes (e.g., from 

gas forklifts), and odors (e.g., from hide cellars, grease traps, toilet rooms, 

and inedible tank rooms) to the outside so they don’t accumulate and enter 

edible areas where they can be absorbed by exposed product. 

	 Provides air from the outside that is free of odors from livestock pens and 

inedible areas, dust, fumes, and other airborne contaminants that can 

Inspection Methods	 11-31 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

contaminate product. If air is exhausted from the establishment, air from 

somewhere else will replace it. 

Note: The Agency does not expect the establishment to completely eliminate all 

odors, vapors, and condensation. However, establishments must control the 

airborne contaminants such as odors, vapors and condensate (mists) to prevent 

adulteration of the environment that can lead to creation of insanitary conditions 

or the adulteration of product. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s ventilation system where 

products are processed, handled, or stored and in employee welfare rooms. IPP 

should verify that the establishment’s ventilation is adequately controlling the 

formation of vapors (including steam) and condensate, and promptly removing 

objectionable vapors and odors that could create insanitary conditions or 

adulterate product from the establishment. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Is the ventilation adequate to control objectionable odors and vapors 

that could adulterate product or mask the odor of spoiled or otherwise 

adulterated product? 

Is the ventilation adequate to control condensation? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for a build-up of condensation in rooms where product is processed, 

handled, or stored. 

Note: Condensate is free moisture formed on a surface or in the air when there 

is too much water vapor for the air to hold. Condensate is formed only when the 

temperature of the air or surface is below the dew point of the surrounding 

atmosphere. When condensate forms in air, it becomes fog. When condensate 

forms on a surface, it wets it, and if the condition persists, the moisture 

accumulates to the point of forming droplets that fall from a horizontal surface or 

run down a vertical or inclined surface. Some areas where condensate is likely 

to form include ceilings above cooking vessels and poultry chill vats, the ceiling 

around refrigeration units, or on the bottom of refrigeration units in processing 

areas. 

Inspection Methods	 11-32 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for a build-up of condensation on the ceilings of coolers and freezers or 

the bottom of refrigeration units in these areas. 

	 Look for objectionable vapors and odors, e.g., ammonia and diesel fumes, in 

areas where product is processed, handled, or stored. 

	 Look for air intakes in areas where product is processed, handled, or stored, 

bringing in air contaminated with dust, smoke, and odors. 

	 Look for airflow carrying contaminants from an area in the establishment 

being remodeled to a product area in the establishment. 

	 Look for airflow carrying foul odors from toilet rooms entering areas where 

product is processed, handled, or stored. 

	 Look for air flowing from raw product areas to ready-to-eat product areas. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s ventilation that is creating 

an insanitary condition, there is noncompliance with the requirements of 

§416.2(d) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Inspection Methods	 11-33 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

Scenario 

You observe condensation that has formed on the underside of the stainless 

steel lid covering a large kettle during cooking. The cooking kettles, including the 

lids, are cleaned, sanitized, and monitored as part of the establishment’s written 

SSOP. In this case, the condensation has no affect on product safety, sanitary 

conditions, or inspection. In regards to condensation, you need to keep in mind 

that some forms of condensation are unavoidable and acceptable as long as the 

establishment controls the condensation to ensure that it does not create an 

insanitary condition or adulterate product. 

Scenario 

You observe beaded condensation on the ceiling directly above carcasses stored 

in the carcass holding cooler. You look for evidence that the condensate has 

dripped from the ceiling, e.g., drops on the floor between carcasses. You do not 

see any dripping condensate or find any evidence for you to conclude that 

condensate has contacted the carcasses. At this point, there is noncompliance 

with §416.2(d) because an insanitary condition exists that could lead to product 

contamination or adulteration and you would document this noncompliance on an 

NR. 

If the condensate had built up enough to be dripping onto the carcasses and the 

establishment could demonstrate there were no food safety hazards associated 

with the contamination, you would document this under the appropriate SSOP 

task. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is air from an area where raw product is handled flowing into an area 

where ready-to-eat product is handled. 

	 A foul odor emanating from a restroom is entering an area where product is 

processed and handled. 

	 Diesel fumes from parked trucks are being drawn into the receiving coolers. 

	 Beaded condensate is on the bottom of a refrigeration unit (not equipped with 

a drip pan) in an area where product is processed, handled, or stored. 

Inspection Methods	 11-34 
 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

**************************************************************************************** 

§416.2(e) Plumbing 

Plumbing is a particularly important consideration in food establishments. 

Because plumbing systems transport water to and from establishments, 

problems with the plumbing system can easily lead to product contamination or 

adulteration. Plumbing impacts the establishment’s water supply, drainage, and 

sewage disposal systems. 

Plumbing systems must be installed and maintained to: 

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

throughout the establishment; 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that the plumbing system 

provides enough potable water for sufficient cleaning of equipment and utensils, 

facilities, hands, outside areas, etc., to prevent product adulteration or creation of 

insanitary conditions. 

Note: An adequate supply of water is critical in sanitation programs and 

establishment operations. Reduced water pressures, resulting from improperly 

sized and maintained pipelines, may adversely affect various washing operations 

and cleaning equipment that depend upon specific water pressure and volume to 

perform their intended functions. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s potable water supply system 

in one or more areas of the establishment. IPP should verify that the system 

can provide water in quantities sufficient for all operating needs. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are sufficient quantities of water provided throughout the 

establishment? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

Inspection Methods	 11-35 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for inadequate amounts of water in areas of the establishment that 

require wet cleaning operations. 

 Look for inadequate amounts of water for flushing inedible materials (e.g., 

feathers and viscera) down the troughs in poultry slaughter operations. 

	 Look for inadequate amounts of water for scalding birds in poultry slaughter 

operations. 

	 Look for the absence of hot and cold water outlets in areas that require wet 

cleaning operations, e.g., near livestock pens, grease catch basins or traps, 

and outside inedible material removal areas. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s potable water supply 

system that is creating an insanitary condition, there is noncompliance with the 

requirements of §416.2(e)(1) and IPP should document that noncompliance on 

an NR. If the conditions IPP observed are not creating an insanitary condition or 

adulteration of product, the establishment is in compliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 The water flow rate for removing inedible poultry viscera from the production 

room is inadequate, allowing the viscera to pile up in the trough. 

Inspection Methods	 11-36 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 There are no water outlets in an area of the official premises that requires the 

removal of fat, grease, blood, meat juices, feathers, manure, etc. 

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

establishment; 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that sewage lines, drainage 

lines, and floor drains are of sufficient size to permit prompt removal of sewage 

(from toilet bowls and urinals) and liquid waste or waste water (e.g., water that 

contains blood, fat, animal fecal material, or product residues) from the 

processing environment and official premises. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the waste disposal system in one or more areas 

in or outside the establishment. IPP should verify that the drainage system is 

designed to promptly remove waste materials from the establishment. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Does the plumbing system properly convey sewage and disposable 

waste from the establishment? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for blocked or clogged floor drain inlets and drain lines. 

Note: Frequently blocked or clogged drains may be too small to accommodate 

the amount of waste material being removed. 

	 Look for accumulations of water in the bottom of ice storage compartments. 

	 Look for catch basins or traps for recovering grease located near edible 

product departments and in areas where edible products are received and 

shipped. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

Inspection Methods	 11-37 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. 

IPP should use good judgment in making these determinations and might seek 

answers to the following questions in order to determine if there is 

noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s waste (solid and liquid) 

disposal system that is creating an insanitary condition, there is noncompliance 

with the requirements of §416.2(e)(2) and IPP should document that 

noncompliance on a NR. If the conditions IPP observed are not creating an 

insanitary condition or adulteration of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is a clogged drain in a production area allowing waste water to backup 

onto the floor. 

	 An ice storage compartment allows the water from melted ice to collect in the 

bottom. 

	 A grease trap located on the official premises is giving off a foul odor. 

**************************************************************************************** 

§416.2(e)(3) Prevent adulteration of product, water supplies, equipment, 

and utensils and prevent the creation of insanitary conditions throughout 

the establishment; 

Inspection Methods	 11-38 
 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that its plumbing system 

distributes a potable water supply throughout the establishment in quantities 

sufficient for all operating needs and the drainage and sewage lines permit the 

rapid removal of waste from the establishment without adulterating product or 

creating insanitary conditions. 

Note: All plumbing should be sized, installed, and maintained in accordance with 

applicable State and local plumbing laws, ordinances, and regulations. If the 

plumbing system is not properly designed, installed, or maintained, 

contamination of the water supply, product, equipment, or utensils can occur or 

be created from conditions like cross-connections, backflow, flooding, drain 

system stoppage, and overhead leakage. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s plumbing system in one or 

more areas of the establishment. IPP should verify that the establishment’s 

plumbing system is designed, installed, and maintained to prevent product 

contamination and adulteration. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Does the plumbing system’s design, installation, and maintenance 

prevent adulteration of product, contamination of water supplies, 

equipment and utensils, and the creation of insanitary conditions in the 

establishment? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for dead-end pipes attached to the water supply system. 

Note: Short lengths of capped pipes are considered to be dead ends. For 

instance, a tee with one opening plugged is not a dead-end pipe, but any length 

of capped pipe extending from the tee is a dead-end pipe. A dead-end pipe may 

serve as a reservoir for stagnant water where microorganisms can grow. 

	 Look for leaking wastewater drainage and sewage lines in production areas 

and employee welfare rooms. 

Inspection Methods	 11-39 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for potable water that has an off odor, color, or taste, or contains rust 

and scale. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. 

IPP should use good judgment in making these determinations and might seek 

answers to the following questions in order to determine if there is 

noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s plumbing system that is 

creating an insanitary condition, there is noncompliance with the requirements of 

§416.2(e)(3) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 A dead-end pipe is attached to a potable water supply line. 

	 A waste water drainage pipe that is a few feet above the floor and runs along 

the wall of the cutting and boning room has a small leak at an elbow. 

**************************************************************************************** 

§416.2(e)(4) Provide adequate floor drainage in all areas where floors are 

subject to flooding-type cleaning or where normal operations release or 

discharge water or other liquid waste on the floor; 

Inspection Methods	 11-40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that all parts of floors where 

waste water is discharged onto the floor, wet cleaning operations are conducted, 

or where floors are frequently hosed down are well drained to prevent 

accumulation of waste and the spread of contaminants during operations. 

Note: Establishment wastewater usually contains contaminants such as 

disease-producing and spoilage microorganisms. Therefore, contaminated fluids 

like wastewater that accumulates on the floor or flows across a floor for long 

distances can create insanitary conditions. For instance, the accumulation of 

liquid and suspended solid waste can create objectionable odors in working 

areas, make proper cleaning impossible, and be tracked through production 

areas by employees, increasing the likelihood of product contamination. 

►Verifying Compliance with This Regulation 

IPP should examine and assess drainage in one or more areas with wet cleaning 

operations or where wastewater is discharged on the production floor during 

operations. IPP should verify that the floor is well drained and the drainage of 

wastewater does not create insanitary conditions or adulterate product. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Does the plumbing system provide adequate floor drainage? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for floors with areas including low spots in traffic areas where solid 

waste or wastewater pools or collects because the floor is not sloped or 

pitched toward the drain. 

	 Look for wastewater discharged from soaking and cooking vats, tripe 

scalders, chilling tanks, or other large vessels during operations that travels 

across the floor in traffic areas before entering a drain. 

	 Look for drainage lines that allow waste water from handwashing facilities and 

meat wash sinks that discharge water onto floors of product handling or 

storage areas 

Inspection Methods	 11-41 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for drainage lines from drip pans of overhead refrigeration units that 

discharge water onto the floor. 

	 Look for wastewater from poultry transfer belts with continuous washing 

systems that flow across the floor carrying organic waste to other areas of the 

room before entering a drain. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to establishment drainage that is creating an 

insanitary condition, there is noncompliance with the requirements of 

§416.2(e)(4) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 Water from drip pan drainage lines is flowing across the floor to the floor drain 

located in the middle of the cooler. 

	 Liquid and suspended solids (wastewater) are accumulating in a low area of 

the production room floor where employees walk. 

**************************************************************************************** 

Inspection Methods	 11-42 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

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

piping systems that discharge waste water or sewage and piping systems 

that carry water for product manufacturing; and 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that its water distribution 

system is free of possible pollution or contamination sources such as backflow 

and cross-connections between non-potable water, wastewater, or sewage lines 

and potable water lines. 

Note: Maintaining the integrity of the water supply system within the 

establishment is critical to product safety. A chief concern is the possibility of 

contamination of the water distribution system within the establishment, and that 

the water becomes a vehicle for the transmission of disease-causing organisms. 

►Types of Cross-Connections 

A cross-connection is an actual or potential link between the potable water 

supply and a source of contamination (sewage, foreign materials, chemicals, 

etc.). A direct (or permanent) cross-connection is one where a potable water line 

has actually been plumbed (solid-pipe connection) to a non-potable water (e.g., 

recirculated process water, untreated river water, or wastewater) line. An indirect 

(or temporary) cross-connection is one in which the end of a water faucet or 

outflow end of the line terminates below the flood level of the sink, kettle, vat, etc. 

Contamination or pollution occurs when the pressure differentials between the 

water supply and another system (reuse water, non-potable water, etc.), via a 

connection, are sufficient to transfer contaminants or pollutants into the potable 

supply. Temporary reversal of pressures or momentary vacuums in the water 

supplies can be unpredictable. 

►Backflow 

Backflow is the flow of water or other liquids that is opposite to the expected or 

intended direction. Backflow is undesirable; however, a potable water system 

protected with backflow preventing devices can remain safe. Backpressure (a 

pushing force) and back-siphonage (a vacuum pulling force) are two forms of 

backflow. 

Backpressure is a concern in establishments with two or more piping systems. 

Backpressure occurs when both systems (potable and non-potable water) are 

under pressure but the non-potable system has greater pressure than the 

potable system, which pushes the contaminated water into the potable water 

Inspection Methods 11-43 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

supply. For backpressure to occur, a direct (solid pipe) connection between the 

two water systems has to exist. 

Back-siphonage occurs when the pressure in the potable system drops below 

zero (or has negative pressure), which draws or pulls (siphons) the contaminated 

water into the potable water supply. Back-siphonage can occur with an indirect 

(submerged inlets) or direct (solid-pipe) cross-connection. 

►Potable Water Supply Protection from Cross-Connections 

Once a cross-connection exists, a ruptured water main, a sudden large water 

withdrawal, or any situation that causes a pressure differential, with the potable 

system having the lower pressure or negative pressure, can result in the reverse 

flow of fluid (backpressure or back-siphonage) and contamination of the entire 

water distribution system and potable water supply. Hence, direct crossconnections between potable and non-potable water lines must not exist and 

equipment installations where submerged water inlets are unavoidable must be 

equipped with mechanical anti-backflow devices (vacuum breakers) to protect 

the potable water supply from contamination. 

A vacuum breaker admits atmospheric pressure to a piping system between the 

source of the pollution and the origin of the vacuum, preventing back-siphonage. 

To be effective, the vacuum breaker should be installed between the last cutoff 

valve and the submerged water line. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s water distribution system in 

one or more areas of the establishment. IPP should verify that there are no 

cross-connections between potable water lines and other piping systems to 

prevent backflow to the water supply system. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Is the plumbing installed to prevent backflow conditions and crossconnections between piping systems that discharge wastewater or 

sewage and piping systems that carry water for product manufacturing? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

Inspection Methods	 11-44 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for direct cross-connections between potable water lines and nonpotable water lines, waste water lines, or sanitary (toilet and urinal) lines. 

Note: Non-potable water (e.g., untreated water from a river or lake or water from 

an untested source such as a private well) may be used in establishments for 

limited purposes. Cross-connections are hard to recognize or discover because 

of their location. For IPP to determine if there are possible cross-connections 

between the potable water supply and the non-potable water supply, IPP may 

ask the establishment for assistance in distinguishing potable water lines from 

non-potable lines. 

	 Look for direct cross-connections between lines carrying water or solutions for 

reuse and lines carrying potable water. 

	 Look for water lines with submerged inlets in processing equipment not 

equipped with mechanical vacuum breakers to prevent back-siphonage. 

Note: Submerged inlets are created when the outflow end of a potable water 

line is covered with water or other liquid. The water or liquid may not be potable. 

When IPP identify a submerged potable water inlet on a piece of equipment, IPP 

should ask the establishment to show IPP the location of the vacuum breaker. 

	 Look for cleanup hoses with ends or nozzles submerged in sinks, defrost 

tanks, cleaning solution tanks, clogged drains, puddles of water on floor, etc., 

not equipped with mechanical vacuum breakers. 

Note: When IPP identify a submerged hose end in a drain, tank, sink, etc., IPP 

should ask the establishment to show the location of the vacuum breaker. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s water distribution system 

that is creating an insanitary condition, there is noncompliance with the 

requirements of §416.2(e)(5) and IPP should document that noncompliance on 

Inspection Methods	 11-45 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

an NR. If the conditions IPP observed are not creating an insanitary condition or 

adulteration of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 A water hose not equipped with a vacuum breaker to prevent back-siphonage 

has its nozzle submerged in the evisceration trough drain. 

	 There is a cross-connection with a shut off valve between the potable water 

supply and the non-potable water supply. 

******************************************************************************** 

§416.2(e)(6) Prevent the backup of sewer gases. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that foul odors (sewer gases) 

from sink and floor drains do not enter the establishment. 

►Verifying Compliance with This Regulation 

IPP should examine and assess sink and floor drains in one or more areas in the 

establishment. IPP should verify that the drain is not allowing sewer gases to 

enter the establishment. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Is the plumbing installed to prevent the backup of sewer gases? 

To assist IPP in answering this question, look for drains in the establishment that 

are emitting sewer gases. 

Inspection Methods	 11-46 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

Note: The floor drainage system is usually sealed off so that sewer gases do not 

enter the establishment by equipping drains, including blood drains, with a deep 

seal trap and a vent to the outside. The effectiveness of the trap depends upon 

enough water remaining to constitute a seal. As water flows through the trap and 

down the drainpipe, a suction is created that will pull the water out of the trap and 

break the seal unless the suction is broken by venting the drain pipe to the 

outside air. The seal can also be broken by evaporation of trapped water. 

Therefore, drains installed in areas where there is seldom any wet cleanup are 

more likely to emit foul odors because the water in the trap has evaporated. 

2. Assess the Information Gathered by IPP. 

When IPP find a drain in the establishment emitting sewer gases, it is creating an 

insanitary condition, and there is noncompliance with the requirements of 

416.2(e)(6). For example, if IPP found a floor drain in a cooler allowing the 

release of sewer gases, IPP should document this noncompliance on an NR. 

**************************************************************************************** 

§416.2(f) Sewage disposal 

Sewage must be disposed into a sewage system separate from all other 

drainage lines or disposed of through other means sufficient to prevent 

backup of sewage into areas where product is processed, handled, or 

stored. When the sewage disposal system is a private system requiring 

approval by a State or local health authority, the establishment must 

furnish FSIS with the letter of approval from that authority upon request. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

 Sewage from sanitary (toilet bowl and urinal) drainage lines is disposed of in 

a manner that prevents the backup of fluid and suspended waste containing 

human waste onto processing area floors. 

 An approval letter from a State or local health authority is filed on-site and 

available to FSIS upon request when its sewage disposal system is a private 

system that must be approved. 

Inspection Methods 11-47 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s sewage system. IPP should 

verify that sewage from toilets and urinals is removed from the establishment in 

drainage lines that are separate from hand washing lavatory, floor, and 

equipment drainage lines or disposed of in different manner that prevents the 

backup of sewage onto processing area floors. 

IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Is the sewage disposed into a sewage system separate from all other 

drainage lines or other means to prevent backup of sewage into areas 

where product is processed, handled, or stored? 

If the sewage disposal system is a private system requiring approval by a 

State or local health authority, is the letter of approval available to FSIS 

upon request? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for drainage lines from toilets or urinals connected to other drainage 

lines in the establishment. 

	 Look for an approval letter on file if the establishment has a private system to 

dispose of sewage that must be approved by a State or local health authority. 

	 Look for drainage lines from toilets or urinals that drain into grease catch 

basins or traps. 

Examples of the failure to meet the requirements for this regulation are: 

	 The establishment has no documentation on file from a State or local health 

authority for approval of a private sewer system when approval is required. 

	 The establishment’s toilet bowls and urinals drain into the establishment’s 

grease recovery catch basin. 

Inspection Methods	 11-48 
 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

SPS REGULATIONS WORKSHOP #2 

Multiple Choice Questions 

1.	 The SPS regulations: 

a.	 Require establishments to develop, implement, and maintain written 

procedures it conducts daily, before and during operations, to prevent 

product from direct contamination and adulteration. 

b.	 Address areas or conditions in and around the establishment that may 

result in insanitary conditions that could lead to the adulteration of 

product. 

c.	 Cover the scheduled, daily pre-operational and operational cleaning 

and sanitation of equipment and surfaces that directly contact product. 

2.	 The grounds and pest control performance standard requires the 

establishment to: 

a.	 Store useful materials and equipment in an orderly manner on elevated 

racks at least 12 inches high outside the establishment. 

b.	 Have a pest management program in place to prevent the harborage 

and breeding of pests on the grounds and within the establishment. 

c.	 Provide concrete paving extending at least 20 feet from the building, at 

loading docks, livestock chutes, or other areas where vehicles or 

loaded and unloaded. 

Inspection Methods	 11-49 
 

 

 

 

Sanitation Performance Standards 

11-28-2016 

3.	 Which of the following statements regarding the grounds and pest control 

performance standard is true? 

a.	 The establishment does not have to prevent potential sources of 

product contamination or adulteration if the source originates from 

conditions outside the official premises of the establishment. 

b.	 The establishment’s pest management program must be a written 

document. 

c.	 Documents supporting the safe and effective use of a pest control 

substance must be available for FSIS review. 

d.	 Pest control substances used on the official premises must be 

approved by FSIS prior to use. 

4.	 Which of the following statements is not found in the performance standard 

for construction? 

a.	 Doors and doorjambs that may contact product must be clad with a 

rust-resistant metal, e.g., stainless steel, with tightly soldered or 

welded seams, and the juncture of the doorjamb sealed with an 

effective sealing compound. 

b.	 Establishment buildings, including their structures, rooms, and 

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

c.	 Walls, floors, ceilings, doors, windows, and other outside openings 

must be constructed and maintained to prevent the entrance of vermin. 

d.	 Walls, floors, and ceilings within establishments must be built of 

durable materials impervious to moisture. 

Inspection Methods	 11-50 
 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

5.	 The lighting performance standard requires the establishment to: 

a.	 Provide a minimum of 50 foot candles of shadow-free light in areas 

where food is processed, handled, stored, and examined. 

b.	 Cover light bulbs, fixtures, skylights, or other glass suspended over 

exposed food in any stage of preparation with a non-shattering 

protective shield, or provide safety-type light bulbs. 

c.	 Provide lighting intense enough to allow both establishment and 

inspection personnel to determine if sanitary conditions are maintained 

and that product is not adulterated in areas where food is processed, 

handled, stored, and examined. 

d.	 Provide a minimum of 30 foot candles of shadow-free light in areas 

where food is processed, handled, stored, and examined so that both 

establishment and inspection personnel can determine if sanitary 

conditions are maintained and that product is not adulterated. 

6.	 The ventilation performance standard requires the establishment to: 

a.	 Prevent all odors and vapors in production areas. 

b.	 Control odors, vapors, and condensation to prevent product 

adulteration. 

c.	 Prevent the formation of any condensation inside the establishment. 

7 Which statement is not found in the performance standard for plumbing? 

a.	 The establishment’s plumbing system must provide adequate floor 

drainage in all areas where floors are subject to flooding-type cleaning. 

b.	 The establishment’s plumbing system must prevent sewer gases from 

entering the establishment. 

c.	 Hot and cold water outlets must be equipped with functioning 

mechanical anti-backflow devices. 

d.	 The establishment’s plumbing system must properly convey sewage 

and liquid disposable waste from the establishment. 

Inspection Methods	 11-51 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Matching Question 

Match the statement in the left column with the correct term in the right column. 

The dispersal of insecticides into the air of a 

specific space/room by foggers, misters or 

aerosol devices. 

A short length of capped pipe extending from a 

tee. 

An actual or potential link between the potable 

water supply and a source of contamination 

(sewage, waste water, etc.). 

The boundaries of the establishment and the 

limit of the IPP’s inspection responsibilities. 

Production rooms or production-related areas 

such as dry ingredient storage area, spice 

room, cooler, packaging material and container 

dry storage area, or any other area where 

meat and poultry product is accessible. 

Electrical rooms, boiler rooms, maintenance 

rooms, welfare facilities, business offices, or 

similar places. 

Flow of water or other liquids that is opposite 

to the expected or intended direction. 

Admits atmospheric pressure to a piping 

system between the source of the pollution 

and the origin of the vacuum, thus preventing 

back-siphonage. 

Applying a liquid spray insecticide to hit the 

individual insect or treat a specific surface 

such as a floor-wall junction 

A.	 Official Premises 

B.	 Space Treatment 

C.	 Backflow 

D.	 Processing Areas 

(Pesticide Application) 

E.	 Cross-Connection 

F.	 Dead-End Pipe 

G.	 Surface Treatment 

H.	 Nonprocessing Areas 

(Pesticide Application) 

I.	 Vacuum Breaker 

Inspection Methods	 11-52 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Fill-in the Blank Questions 

Refer to the module to fill in the blanks. 

1. Pest control substances used must be and under the 

conditions of use and not be or in a manner that 

will result in the adulteration of product or the creation of insanitary conditions. 

2. Establishments can process, handle, or store edible and inedible product in 

the same room as long as they are separated by or in a 

manner that prevents adulteration of the edible product. 

3. Sewage must be disposed into a separate from 

all other or disposed of through other means 

sufficient to prevent backup of sewage into areas where product is processed, 

handled, or stored. 

4. installations where submerged water inlets are unavoidable 

must be equipped with to protect the water 

supply from contamination. 

**************************************************************************************** 

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

Water is used to clean facilities and equipment in meat and poultry 

establishments. In many operations, water is used as an ingredient in product 

formulations. Water, unless it comes from a safe supply, may serve as a source 

of contamination of product, equipment, utensils, and hands. 

§416.2(g)(1) A supply of running water that complies with the National 

Primary Drinking Water regulations (40 CFR part 141), at a suitable 

temperature and under pressure as needed, must be provided in all areas 

where required (for processing product, for cleaning rooms and equipment, 

utensils, and packaging materials, for employee sanitary facilities, etc.). If 

an establishment uses a municipal water supply, it must make available to 

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

or local health agency, certifying or attesting to the potability of the water 

supply. If an establishment uses a private well for its water supply, it must 

make available to FSIS, upon request, documentation certifying the 

potability of the water supply that has been renewed at least semi-annually. 

Inspection Methods 11-53 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Running water is distributed under adequate pressure and at a sufficient 

temperature to areas of the establishment that require a water supply. 

	 Its water supply meets the potability standards in the National Primary 

Drinking Water Regulations issued by the EPA. If the establishment uses a 

municipal water supply, documentation attesting to the water supply meeting 

National Primary Drinking Water Regulations needs to be filed on-site and 

available to FSIS upon request. In the absence of such documentation, a 

water potability certificate or report from a State or local health agency or 

other responsible entity certifying potability filed on-site and available to FSIS 

upon request will be sufficient. There is not a mandatory renewal period for 

the potability certificate from a municipal source. 

	 A water potability certificate or report from a State or local health agency or 

other responsible entity certifying potability is filed on-site and available to 

FSIS upon request when its water supply comes from a private well. The 

potability certificate or report must be renewed semi-annually. 

	 Documentation stating that any water used to make ice being supplied to the 

establishment meets the National Primary Drinking Water regulations or a 

water report from a State or local health agency or other responsible entity 

certifying that the ice being supplied is made from potable water is filed onsite and available to FSIS upon request when the establishment uses ice from 

a different water source in the preparation of product. 

	 Ice to be used in direct contact with product or food equipment is handled in a 

sanitary manner. 

Note: A water report (laboratory analysis) provided by the State or local health 

agency or other responsible entity certifying potability on file is acceptable in lieu 

of documentation stating that the establishment’s water supply meets the 

National Primary Drinking Water requirements. A laboratory report that properly 

attests to the water supply as being potable may state that the water is potable 

or indicate the absence of coliform bacteria. “Potable” simply means 

drinkable or safe for human consumption or food processing. 

The National Primary Drinking Water Regulations were promulgated under the 

authority of a 1986 law known as The Safe Drinking Water Act. Public or 

Inspection Methods	 11-54 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

municipal water supply systems (classified by EPA as "Community Water 

Systems") are the major source of water for meat and poultry establishments. 

Some meat and poultry establishments use private wells for their water supply. 

EPA classifies private industrial well water supplies as "Noncommunity Water 

Systems" and does not require testing for potability. FSIS, however, requires 

water from a private well to be tested and certified as potable semi-annually. 

Generally, state and local governments do not test private wells for potability. 

Private laboratories will test the well water and provide establishments with 

potability certificates. 

Water from any source not tested for potability or certified as meeting the 

National Primary Drinking Water requirements is automatically considered to be 

a nonpotable supply. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s water supply in one or more 

areas of the establishment. IPP should verify that the water is at an adequate 

pressure and temperature for its intended purpose and that ice is made and 

handled in a sanitary manner. IPP should also verify that documentation stating 

that the water in the establishment complies with the EPA’s National Primary 

Drinking Water regulations or the required water potability certificates are on file 

and available to IPP upon request. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Does the establishment have documentation that the water in the 

establishment complies with the EPA’s National Primary Drinking Water 

Regulations? 

OR 

If the establishment uses a municipal water supply, does it have a water 

report issued under the authority of the State or local health agency 

certifying or attesting to the potability of the water supply? 

Is there adequate water pressure, at a suitable temperature, in all areas 

where required, for example, for processing product; for cleaning 

rooms, equipment, and utensils; and for employee sanitary facilities? If 

the establishment uses a private well for its water supply, does the 

establishment have on file documentation certifying the potability 

Inspection Methods	 11-55 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

of the water supply that is renewed semi-annually? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for water supplies with inadequate pressures and/or temperatures to 

accomplish thorough cleanup, e.g., remove fat, oil, meat juices, blood, 

manure, etc., from the surface being cleaned. 

	 Look for water spray washing equipment with insufficient pressure to 

thoroughly wash carcasses. 

	 Look for documentation on file that states the water used in the establishment 

meets EPA’s National Primary Drinking Water regulations when its water 

comes from a municipal source. 

	 Look for a water potability certificate or report on file when there is no 

documentation attesting to the fact that the establishment’s water meets 

EPA’s National Primary Drinking Water regulations when its water comes 

from a municipal source. 

	 Look for a current water potability certificate or report on file when the water 

used in the establishment comes from a private well. 

2.	 Assess the Information Gathered by IPP. 

If IPP do not find documentation on file that states the water used in the 

establishment meets EPA’s National Primary Drinking Water regulations or a 

water potability certificate or report when the water comes from a municipal 

source or a current water potability certificate or report when the establishment’s 

water supply comes from a private well or the documentation or certificate is not 

available upon request, it would represent noncompliance with §416.2(g)(1). 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Inspection Methods	 11-56 
 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s water or ice supply that is 

creating an insanitary condition, there is noncompliance with the requirements of 

416.2(g)(1) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 Water at a sufficient temperature is not available at any of the water outlets in 

a room where product is processed, handled, and stored. 

	 The establishment cannot produce documentation that its municipal water 

supply complies with the National Primary Drinking Water regulations or a 

potability certificate. 

	 The establishment’s current water potability certificate for its private well is 

two years old. 

**************************************************************************************** 

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

propylene glycol) used to chill or cook ready-to-eat product may be reused 

for the same purpose, provided that they are maintained free of pathogenic 

organisms and fecal coliform organisms and that other physical, chemical, 

and microbiological contamination have been reduced to prevent 

adulteration of product. 

§416.2(g)(3) Water, ice, and solutions used to chill or wash raw product 

may be reused for the same purpose provided that measures are taken to 

reduce physical, chemical, and microbiological contamination so as to 

prevent contamination or adulteration of product. Reuse that has come 

into contact with raw product may not be used on ready-to-eat product. 

Inspection Methods	 11-57 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Establishment’s Responsibilities 

Water reuse is an important consideration because meat and poultry operations 

require large amounts of potable water. Control of pathogens in water used in 

processing is essential for ensuring that meat and poultry products do not 

become adulterated. Technologies are available that effectively recondition 

water so that it is safe to reuse in a number of processing operations. 

The establishment has the responsibility to ensure that: 

	 Product is not adulterated by reused water, ice, or solutions and the sanitary 

conditions are not compromised. 

	 Water, ice, or a solution used to chill or cook ready-to-eat product is free of 

pathogenic organisms and fecal coliform organisms and has been handled to 

reduce physical, chemical, and microbiological contaminants before being 

reused for the same purpose. Ready-to-eat product is a product that that can 

be eaten by the consuming public with little or no further processing. 

Examples include franks, bologna, ham, and cooked corned beef. 

	 Water, ice, or a solution used to chill or wash a raw product has been handled 

to reduce physical, chemical, and microbiological contaminants before being 

reused for the same purpose. Raw product (e.g., uncooked meat and poultry, 

vegetables, and ingredients) may be contaminated with pathogenic 

microorganisms and fecal coliforms, so reuse water must have those 

contaminants reduced. For example, a establishment that re-circulates water 

in a chill tank for raw poultry might add chlorine to the water to reduce the 

number of pathogens. 

	 Water, ice, or solutions that have been used on raw product are not used on 

ready-to-eat product. To minimize the possibility of cross-contamination 

between different types of products (ready-to-eat and raw) or processes, 

water can be reused only for the same purpose. 

Note: The requirement that water be reused only "for the same purpose" 

means that water used to chill, wash, or otherwise process raw product may be 

reused to chill, wash, or otherwise process raw product even at a different 

step in the process provided that “measures” are taken to reduce physical, 

chemical, and microbial contamination. For example, the establishment may 

reuse reconditioned chiller water from the final bird washer in the scalding tank. 

In addition, water used to process ready-to-eat product (e.g., fully cooked corned 

beef) could be reused to wash or process raw product (e.g., blanch pinto beans). 

Inspection Methods	 11-58 
 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

Water used to process raw product may not be reused to process ready-to-eat 

product. 

For instance, the establishment could not reuse poultry chiller water for cooking 

or chilling ready-to-eat product (e.g., fully cooked poultry rolls). The likelihood of 

hazards occurring as a result of the establishment’s water reuse system should 

be addressed in the establishment’s hazard analysis. If hazards are likely to 

occur when the material (e.g., brine, ice, water, or other solution) is reused, water 

treatments or reconditioning controls such as filtering, screening, the addition of 

chlorine, etc., that are designed to eliminate and reduce them will be 

incorporated into the establishment’s HACCP plan. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the reuse of water, ice, or solutions that contact 

edible product. IPP should verify that the reuse is for the same purpose, that 

measures have been taken to reduce physical, chemical, and microbiological 

contaminants, and that water, ice, or solutions reused on ready-to-eat product 

are free of pathogenic organisms and fecal coliforms. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are water, ice, and solutions that are reused, maintained free of 

pathogenic organisms and fecal coliform organisms?
 

Is other physical, chemical, and microbiological contamination reduced 

to prevent adulteration of product? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for water, ice, and solution reuse in the establishment’s hazard analysis. 

	 Look for a Critical Control Point (CCP) and the procedures for handling water, 

ice, and solutions for reuse in the HACCP plan if the establishment found a 

food safety hazard reasonably likely to occur with water, ice, or solution 

reuse. 

	 Look for microbiological or chemical analyses (e.g., chlorine or other additive 

concentration) documentation that indicate that the reused water, ice, or 

solution used on ready-to-eat product is free of pathogens. 

Inspection Methods	 11-59 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Look for reused water, ice, or a solution that was not filtered, screened, or 

chlorinated, to reduce physical, chemical, and microbiological contaminants. 

	 Look for water, ice, or a solution that was used to chill or wash raw product 

reused on a ready-to-eat product. 

	 Look for equipment (pipelines, storage tanks) used in handling of reused 

water that is not designed, constructed, installed, or located to facilitate 

cleaning or prevent contamination. 

Note: Water storage tanks should be enclosed and not exposed to the outside 

elements (dust, dirt, insects, or debris). Pipelines should not have dead-ends 

where water can stagnate. 

2.	 Assess the Information Gathered by IPP. 

If the establishment found a food safety hazard reasonably likely to occur with 

water, ice, or solution reuse and does not have a CCP in the HACCP plan, then 

there is noncompliance with the requirements of Part 417 of the regulations. IPP 

would document this noncompliance on an NR using the Hazard Analysis 

Verification task and appropriate HACCP regulations. 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to water, ice, or solution reuse on ready-to-eat 

product that is creating an insanitary condition, there is noncompliance with the 

requirements of 416.2(g)(2). If IPP find any condition relating to water, ice, or 

solution reuse on raw product that is creating an insanitary condition, there is 

noncompliance with the requirements of 416.2(g)(3). IPP should document 

noncompliance on an NR. If the conditions IPP observed are not creating an 

insanitary condition or adulteration of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

Inspection Methods	 11-60 
 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the regulatory requirements for the reuse of 

water, ice, and solutions that contacts edible product are: 

	 Reusing a brine solution to chill bologna without filtering, screening, or 

treating it to reduce physical, chemical, and microbiological contaminants. 

	 Reusing water from raw vegetable rinsing operations to chill cooked hot dogs. 

**************************************************************************************** 

§416.2(g)(4) Reconditioned water that has never contained human waste 

and that has been treated by an onsite advanced wastewater treatment 

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

throughout the facility in edible and inedible production areas, provided 

that measures are taken to ensure that this water meets the criteria 

prescribed in paragraph (g)(1) of this section. Product, facilities, 

equipment, and utensils coming in contact with this water must undergo a 

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

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

►Establishment’s Responsibilities 

Some establishments recondition their water through an advanced wastewater 

treatment facility, either on-site or under contract. 

The establishment has the responsibility to ensure that: 

	 Its reconditioned water has never contained human waste (water from toilet 

bowls and urinals). 

	 Its reconditioned water meets the requirements of §416.2(g)(1). 

	 Its reconditioned water is only used on raw product (e.g., to wash the surface 

of carcasses on the kill floor) and in edible and inedible production areas 

(e.g., to wash equipment and floors) throughout the facility but not in product 

formulations. 

	 Products, facilities, and equipment that have contacted reconditioned water 

undergo a separate final rinse with potable, nonreconditioned water. 

Inspection Methods	 11-61 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s use of reconditioned water 

in one or more areas of the establishment. IPP should verify that reconditioned 

water meets the requirements in §416.2(g)(1) and is used only on raw products 

and not in product formulations, and that any facility, piece of equipment, or 

product that has contacted reconditioned water is rinsed with potable, 

nonreconditioned water. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Is reconditioned water properly applied? 

Does the establishment’s reconditioned water supply meet the EPA’s 

National Primary Drinking Water regulatory requirements as indicated 

by a certificate or other documentation on file? 

Are equipment, facilities, and raw product rinsed with potable, 

nonreconditioned water after contacting the reconditioned water? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for documentation attesting to the fact that the reconditioned water 

meets EPA’s National Primary Drinking Water regulations. 

	 Look for products formulated with reconditioned water. 

	 Look for equipment, floors, or raw product washed with reconditioned water 

that do not receive a separate final rinse with potable, nonreconditioned 

water. 

2.	 Assess the Information Gathered by IPP. 

If IPP do not find documentation on file that states the reconditioned water used 

in the establishment meets EPA’s National Primary Drinking Water regulations or 

the documentation is not available upon request, it would represent 

noncompliance with §416.2(g)(4). 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

Inspection Methods	 11-62 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s reconditioned water that is 

creating an insanitary condition, there is noncompliance with the requirements of 

416.2(g)(4) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 The establishment does not rinse the kill room floors with potable water after 

washing them with reconditioned water. 

	 The establishment used reconditioned water to formulate a pickle solution 

that was pumped into hams. 

**************************************************************************************** 

§416.2(g)(5) Any water that has never contained human waste and that is 

free of pathogenic organisms may be used in edible and inedible product 

areas, provided it does not contact edible product. For example, such 

reuse water may be used to move heavy solids, to flush the bottom of open 

evisceration troughs, or to wash antemortem areas, livestock pens, trucks, 

poultry cages, picker aprons, picking room floors, and similar areas within 

the establishment. 

►Establishment’s Responsibilities 

The establishment can use non-potable water or reuse water for any purpose in 

edible or inedible product areas provided it ensures that the water: 

Inspection Methods	 11-63 
 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

	 Has never contained human waste. Establishment must not reuse water from 

toilet and urinal lines. 

	 Has been conditioned (treated) to be free of pathogenic organisms. Reuse 

water must be free of pathogenic organisms to prevent their introduction into 

and spread throughout the establishment. 

	 Does not contact edible product. Reuse water might contain coliform 

bacteria, chemicals, or physical contaminants, so it cannot contact edible 

product. 

►Verifying Compliance with This Regulation 

IPP should examine and assess the establishment’s use of nonpotable water in 

one or more areas of the establishment. IPP should verify that non-potable 

water used in edible and inedible product areas is free of pathogens and does 

not come into contact with edible product. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Is the nonpotable water maintained free of pathogenic organisms? 

Does the non-potable water used in edible product departments come in 

contact with edible product? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for microbiological or chemical analyses (e.g., chlorine or other additive 

concentration) documentation that indicate that the reused water is free of 

pathogens. 

	 Look for non-potable water (e.g., from a river or lake) used in edible or 

inedible product areas that might not be free of pathogenic organisms. 

	 Look for non-potable water contacting edible product or product components. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

Inspection Methods	 11-64 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s pathogen free nonpotable 

water use that is creating an insanitary condition, there is noncompliance with the 

requirements of 416.2(g)(5) and IPP should document that noncompliance on an 

NR. If the conditions IPP observed are not creating an insanitary condition or 

adulteration of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 Reusing chemically treated water from employee restrooms to clean 

antemortem pens. 

	 Reusing water that has never contained human waste, is free of pathogens, 

but has not been subject to measures that reduce physical, chemical, and 

microbial contamination to rinse raw vegetables to be used in meat food 

products. 

************************************************************************************ 

§416.2(g)(6) Water that does not meet the use conditions of paragraphs 

(g)(1) through (g)(5) of this section may not be used in areas where edible 

product is handled or prepared or in any manner that would allow it to 

adulterate edible product or create insanitary conditions. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that water that might contain 

pathogens, chemicals, or physical contaminants is not used where edible product 

is handled or stored. A non-potable water supply or reuse water that does not 

Inspection Methods	 11-65 
 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

meet the use conditions of paragraphs §416.2(g)(1) through (g)(5) is a potential 

source of contamination. 

►Verifying Compliance with this Regulation 

IPP should examine and assess the establishment’s use of nonpotable water or 

reuse water that might contain pathogens, chemicals, or physical contaminants in 

one or more areas of the establishment. IPP should verify that this type of nonpotable water is not used where edible product is processed, handled, or stored, 

or in a manner that creates insanitary conditions. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Is non-potable water or reuse water that might contain pathogens, 

chemicals, or physical contaminants used where edible product is 

processed, handled, or stored or in a manner that creates insanitary 

conditions? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for non-potable water or reuse water that might contain pathogens, 

chemicals, or physical contaminants being used to clean floors or equipment 

in edible product areas. 

	 Look for non-potable water or reuse water that might contain pathogens, 

chemicals, or physical contaminants being used to chill or wash raw product. 

	 Look for non-potable water or reuse water that might contain pathogens, 

chemicals, or physical contaminants being used in edible product handling 

and storage areas. 

	 Look for objectionable odors created from the use of nonpotable water or 

reuse water that might contain pathogens, chemicals, or physical 

contaminants. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

Inspection Methods	 11-66 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the establishment’s use of nonpotable water 

that might contain pathogens, chemicals, or physical contaminants that is 

creating an insanitary condition, there is noncompliance with the requirements of 

416.2(g)(6) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements of this regulation are: 

	 Using reuse water not meeting the use conditions of paragraphs (g)(1) 

through (g)(5) in the vapor lines serving edible product rendering equipment. 

	 Using water from a lake not meeting the use conditions of paragraphs (g)(1) 

through (g)(5) in hog scalding vats and dehairing machines. 

	 Using water from a well not meeting the use conditions of paragraphs (g)(1) 

through (g)(5) for washing the floors and equipment in edible product 

departments. 

**************************************************************************************** 

§416.2(h) Dressing rooms, lavatories, and toilets 

A potential source of product contamination is cross-contamination from human 

feces, urine, and foreign materials from employee welfare facilities. Employees 

can introduce pathogens into product by handling it with contaminated hands and 

street clothing. Personal belongings carry foreign materials that can indirectly 

contaminate product or food contact surfaces, therefore, areas designated to 

accommodate employees’ personal needs must be designed to prevent 

Inspection Methods	 11-67 
 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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overcrowding and congestion and be conveniently located within the 

establishment. 

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

number, ample in size, conveniently located, and maintained in a sanitary 

condition and in good repair at all times to ensure cleanliness of all 

persons handling any product. They must be separate from the rooms and 

compartments in which products are processed, stored, or handled. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Restrooms are convenient and accessible to establishment employees at all 

times to encourage them to use the appropriate facilities for disposing of 

human wastes. 

	 The Occupational Safety and Health Administration (OSHA) standards in 29 

CFR 1910.141(c)(1)(i) concerning the number of toilet facilities required in the 

workplace are followed when the establishment is constructed or remodeled. 

	 Dressing rooms and toilet rooms are clean, orderly, pest and odor free, and 

maintained in good repair. 

	 Dressing rooms and restrooms are separate from rooms where products are 

processed, handled, or stored. 

►Verifying Compliance with This regulation 

IPP should examine one or more dressing rooms and restrooms in productionrelated areas of the establishment. IPP should verify that dressing rooms and 

restrooms are convenient, ample in size, sanitary, in good repair, and separate 

from product processing, storage, or handling areas. Inspection personnel 

examining dressing rooms and toilets of the opposite sex must make 

arrangements with establishment management before entering. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are the dressing rooms, toilet rooms, and urinals sufficient in number, 

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

condition and in good repair? 

Inspection Methods	 11-68 
 

 

 

 

 

 

 

 

 

 

 

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Are dressing rooms, toilet rooms, and urinals separate from the rooms 

and compartments in which products are processed, stored, or 

handled? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for street clothes and personal belongings like purses, coats, and shoes 

stored in edible product areas. 

	 Look for soiled work clothing (aprons, frocks, uniforms, etc.) under lockers (if 

provided), lying on benches (seats), or on the floor of dressing rooms and 

locker rooms. 

	 Look for trash, dirt, and debris under lockers (if provided) or on the floor of 

dressing rooms or locker rooms. 

	 Look for employees always lining up to use the restroom. 

Note: If IPP believe there is a problem with the number of existing toilet facilities 

in the establishment, the IIC should contact the Policy Development Division 

(PDD) for guidance. 

	 Look for accumulations of used toilet tissue, trash, and debris on the floor of 

restrooms. 

	 Look for nonfunctional commodes and no supply of tissue paper in the 

bathroom stalls. 

	 Look for backed-up (clogged) or overflowing commodes. 

	 Look for dressing rooms, locker rooms, and restrooms that are not separate 

from product processing, storage, or handling areas. 

	 Look for objectionable odors in dressing rooms or restrooms or foul odors 

coming from lockers (if provided). 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers 

Inspection Methods	 11-69 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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to the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to dressing rooms and restrooms that is creating 

an insanitary condition, there is noncompliance with the requirements of 

416.2(h)(1) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 Used toilet tissue is on the floor around several commodes in a restroom 

used by production employees. 

	 Both receptacles in the dressing room are overflowing, allowing used paper 

towels and trash to be tracked around. 

**************************************************************************************** 

§416.2(h)(2) Lavatories with running hot and cold water, soap, and towels 

must be placed in or near toilet and urinal rooms and at such other places 

in the establishment as necessary to ensure cleanliness of all persons 

handling any product. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Handwashing facilities (lavatories or sinks) are located either in the restroom 

or adjacent to it and convenient to employee work areas (e.g., in production 

rooms) for proper and routine hand washing to prevent contamination of 

product and food-contact surfaces. 

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	 Hand wash lavatories or sinks have both hot and cold water and a hand 

cleanser available to aid in reducing microorganisms and removing particulate 

matter found on the hands. 

	 Hand wash lavatories or sinks have a supply of sanitary towels for hand 

drying so employees will not dry their hands on their clothing or other unclean 

materials. 

	 Hand wash lavatories or sinks are accessible and maintained in operating 

order. 

►Verifying Compliance with This Regulation 

IPP should examine and assess one or more hand washing lavatories or sinks 

located in restrooms and production related areas of the establishment. IPP 

should verify that they have hot and cold water, a supply of soap and towels, 

and are located where needed in the establishment. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question 

Are there lavatories with running hot and cold water, soap, and towels 

placed in or near toilet and urinal rooms and other places in the 

establishment as necessary? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for handwash sinks with no hot or cold running water, soap, or towels. 

	 Look for areas where employees handle product that do not have 

handwashing facilities. 

	 Look for inaccessible handwash sinks, e.g., blocked from use by pallets of 

supplies, product, or other items not moveable by hand. 

	 Look for handwash sinks equipped with paper towels for hand drying without 

a receptacle for collecting used towels. 

Note: The regulation does not require a refuse receptacle be placed near hand 

wash sinks. The lack of one, however, could lead to an insanitary condition [see 

§416.4(b)] if used towels were accumulating on the floor around the sink. 

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2. Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to handwash lavatories or sinks that is creating 

an insanitary condition, there is noncompliance with the requirements of 

416.2(h)(2) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe pallets of packaging material blocking access to the only handwash 

sink in the beef patty pack-off area. The sink being inaccessible to employees 

does not mean that there is an insanitary condition. You are still in the area when 

You see an employee cover her mouth and nose with her hand and sneeze. The 

employee goes to the handwash sink to clean her hands but is unable to 

because she cannot get to the sink. Because the employee was unable to clean 

her hand after contaminating it, an insanitary condition that could lead to the 

contamination of product has now been created. There is noncompliance with the 

requirements of 416.5(a), so you should document this noncompliance on an NR. 

Scenario 

You find both foot pedals for turning on the water to the only handwash sink in 

the poultry cut-up room are broken. While looking for the floor supervisor to 

Inspection Methods 11-72 
 

 

 

 

 

 

 

Sanitation Performance Standards 

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inform him of their finding, you observe an employee contaminate his hands by 

opening the lids of several boxes of ice-packed whole birds. The employee 

realizes he has contaminated his hands and goes to the handwash sink to clean 

them. Since there is no water, the employee does not clean his hands. He 

returns to his work area, and removes whole birds from the boxes, and cuts them 

up before you could inform the supervisor of the insanitary condition. In this 

case, an insanitary condition has lead to the direct contamination of product. You 

should document this noncompliance under the appropriate SSOP task and 

regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 There are no paper towels at the only handwash sink in the ready-to-eat 

product room. 

	 There is no hand cleaner in the dispenser for the only handwash sink in the 

cutting and boning room. 

§416.2(h)(3) Refuse receptacles must be constructed and maintained in a 

manner that protects against the creation of insanitary conditions and the 

adulteration of product. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Receptacles and containers for handling, storing, and transporting waste are 

made of materials that do not create an insanitary condition. 

	 The refuse receptacles or containers are maintained in a good state of repair 

and cleaned as needed to avoid creating insanitary conditions. 

►Verifying Compliance with This Regulation 

IPP should examine and assess one or more refuse receptacles or containers in 

welfare facilities or production related areas of the establishment. IPP should 

verify that they are constructed and maintained in a sanitary manner. 

Inspection Methods	 11-73 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question 

Are refuse receptacles constructed and maintained in a sanitary 

manner? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for refuse receptacles or containers made of materials that cannot be 

easily cleaned, e.g., materials that absorb moisture. 

	 Look for refuse receptacles or containers with holes in them that are leaking 

waste materials. 

	 Look for refuse receptacles or containers that are giving off objectionable 

odors. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to refuse receptacles or containers that is 

creating an insanitary condition, there is noncompliance with the requirements of 

416.2(h)(3) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

product, IPP should document the noncompliance using the appropriate SSOP 

task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations 

Inspection Methods	 11-74 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Examples of the failure to meet the requirements for this regulation are: 

	 A plastic trash container in the lunchroom has a hole in the bottom, allowing 

food particles to fall out onto the floor and liquids to drain onto the floor. 

	 A plastic trash container outside the receiving office in the ingredient dry 

storage area has a buildup of soil on the inner surface that is giving off a foul 

odor. 

§416.3 Equipment and Utensils 

Equipment used in meat and poultry slaughter and processing establishments 

range from utensils (simple hand tools) to large, highly complex electronically 

operated machinery. Since product contacts a variety of equipment surfaces, 

there is a potential for it to be contaminated. Equipment design and construction 

can have a significant impact on sanitation in the establishment and the goal of 

preventing product contamination. 

§416.3(a) Equipment and utensils used for processing or otherwise 

handling edible product or ingredients must be of such material and 

construction to facilitate thorough cleaning and to ensure that their use will 

not cause the adulteration of product during processing, handling, or 

storage. Equipment and utensils must be maintained in sanitary condition 

so as not to adulterate product. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Equipment and utensils used in the preparation, handling, and storage of 

edible product and ingredients are not a source of product contamination or 

adulteration. 

	 Equipment and utensils are made of materials that are easy to clean. 

	 Materials used in the construction of equipment will not deteriorate under 

normal use conditions in the establishment, allowing the harborage of 

microorganisms that could lead to adulteration of product. 

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Sanitation Performance Standards 

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	 Equipment is designed, installed, and maintained to prevent deteriorating 

surfaces that could lead to both microorganisms and chemicals being 

transferred to product. 

	 The design, installation, and maintenance of equipment in the establishment 

ensure that all surfaces and parts are capable of being cleaned and 

maintained in a sanitary manner. 

Note: Microorganisms may grow and cause objectionable odors inside 

equipment where meat and poultry fat and juices, cleanup water, and other 

debris are allowed to accumulate. Food-contact surfaces with pits, open seams, 

cracks, crevices, interrupted welds, etc., and external surfaces of equipment with 

open seams, gaps, crevices, inaccessible recesses, etc., may prevent the 

adequate removal of organic matter (product residues) from the surface and 

allow the development of biofilms. A biofilm is composed of closely packed 

colonies of bacteria that have attached themselves to the surface by producing a 

complex carbohydrate or polysaccharide substance that firmly adheres to the 

surface (including stainless steel) and traps nutrients, other microorganisms, fat, 

proteins, and other debris. Once established, these biofilms can transfer 

pathogens to product. Biofilms are not easily removed by ordinary cleaning 

measures and resist penetration of sanitizers. 

	 Equipment is designed and installed in such a manner that foreign materials 

such as lubricants, heat exchanger media, condensate, cleaning solutions, 

sanitizers, and other nonfood materials do not create insanitary conditions or 

adulterate product. 

	 Cleaning and sanitizing of clean-in-place (CIP) systems are as complete and 

effective as the cleaning and sanitizing of disassembled equipment. The CIP 

design should ensure that the circulating cleaning and sanitizing solutions and 

rinse water contact all food-contact surfaces of the equipment. Dead spots in 

the system, i.e., areas not contacted by the circulating cleaning and sanitizing 

solutions and rinse water, could cause insanitary conditions and adulteration 

by permitting the build-up of product residue. The CIP system should be selfdraining because cleaning and sanitizing solutions remaining in the system 

may result in insanitary conditions and product adulteration. 

Note: CIP systems are used on equipment that is difficult or impractical to 

disassemble. CIP equipment is cleaned by circulating detergent solutions and 

rinse water at a flow velocity high enough to remove all product residues from 

internal surfaces. Band saws, mixers, grinders, etc., that are subject to in-place 

manual cleaning are not considered CIP system equipment. 

Inspection Methods	 11-76 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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►Verifying Compliance with This Regulation 

IPP should examine and assess equipment and utensils used to prepare and 

handle edible product in one or more areas of the establishment. IPP should 

verify that the design, construction, and installation of the equipment and utensils 

permits easy cleaning, and that the equipment and utensils are in good repair. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are equipment and utensils used in processing and other handling of 

edible product or ingredients of material and construction that 

facilitates thorough cleaning? 

Are the ice-making equipment, rooms, and augers maintained in good 

repair and sanitary condition? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for corrosion, rust, blisters, pits, cracks or other defects on equipment 

and utensil surfaces. 

	 Look for surfaces of equipment and utensils that can absorb moisture. 

	 Look for difficult-to-clean areas or surfaces on equipment and utensils. 

Note: There are many types of equipment used in the slaughtering and 

processing of meat and poultry products. It is not possible to list all of the pieces 

of equipment or the areas of the equipment that may be difficult to clean. Most 

pieces of equipment have areas that are difficult to clean or are accessible for 

cleaning but are not cleaned on a regular basis. For instance, grinders, 

conveyors, augers, blenders, emulsifiers, patty machines, linkers, stuffers, and 

packaging machines all have areas on them that are difficult to clean. 

Undersides of equipment, around motors, and behind deflectors or guards are 

some of the areas that might not be cleaned regularly and create insanitary 

conditions. IPP should not only learn to look, but should be sensitive to odors 

that might indicate there is an accumulation of product or product juices within a 

piece of equipment that has not had regular cleaning. 

	 Look for surfaces of equipment and utensils that could allow the migration of 

deleterious substances or impart colors or odors to product. 

Inspection Methods	 11-77 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Note: Aluminum, copper, brass, and bronze are metals that can discolor, stain, 

or migrate into the product. For instance, when friction occurs between 

aluminum and meat or fat, a black oxide is produced that discolors the meat. 

When copper and copper alloys (brass and bronze) contact acidic foods like 

meat and poultry, fats or oils, an objectionable greenish discoloration is formed in 

the product. 

	 Look for rough areas or recesses, open seams, gaps, protruding ledges, 

inside threads, bolts, or rivets on food-contact surfaces of equipment and 

utensils. 

	 Look for open seams, gaps, crevices, inaccessible recesses, or slot or hollowheaded fasteners, etc., on nonfood-contact surfaces of equipment. 

	 Look for rough, interrupted, or uneven welds on equipment and utensil 

surfaces. 

	 Look for low areas, depressions, or sagging areas on or in equipment where 

cleanup water may accumulate and create an insanitary condition. 

	 Look for parts or components of equipment such as pulleys, bearings, or 

gears that could contaminate product and food-contact surfaces with foreign 

materials. 

	 Look for equipment and utensils that are not in good repair. 

Note: The equipment in large establishments handles large volumes of product. 

Equipment parts may become worn or damaged under normal use. Equipment 

that is not properly operated or maintained may have damaged or worn parts. 

Therefore, IPP should also learn to listen for noises that are not normal, such as 

metal rubbing on metal. Worn or damaged equipment can create insanitary 

conditions and adulteration of product. 

	 Look for equipment, compartments, and bins used to make and store ice that 

could contaminate the ice. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Inspection Methods	 11-78 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to equipment and utensils that is creating an 

insanitary condition, there is noncompliance with the requirements of 416.3(a) 

and IPP should document that noncompliance on an NR. If the conditions IPP 

observed are not creating an insanitary condition or adulteration of product, there 

is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe a rough, uneven weld with crevices that connects one of the 

agitating paddles to the shaft in a vertical mixer ready for use in the curing room. 

You closely examine the weld and conclude that no product will be contaminated 

when the mixer is used because you found no accumulation of product residue 

stuck in the crevices or around the weld; therefore you document the 

noncompliance on an NR using the appropriate SPS regulations the surface 

does not facilitate cleaning. However, if you had found an accumulation of 

product residue stuck in the crevices or around the weld, then product would be 

contaminated when it came in contact with the weld. If the establishment could 

demonstrate there was no food safety hazard associated with the contamination, 

you would have documented this noncompliance using the appropriate SSOP 

task and regulations. 

Scenario 

You observe a black substance on the surface of a piece of equipment during 

operations. You examine the piece of equipment and the product around it and 

find there is no product contamination occurring; therefore, you document the 

noncompliance using the appropriate SPS regulations. If the black substance 

was contacting product and the establishment could demonstrate there were no 

food safety hazards associated with the contamination, you would document this 

using the appropriate SSOP task and regulations. If the black substance 

contacting the product were coming from a heavy metal, such as lead, the 

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establishment would probably not be able to support the claim that there is no 

food safety hazard associated with that contamination, therefore you would 

document the noncompliance using the appropriate HACCP verification task and 

regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 A food-contact surface of a piece of equipment is corroded and has several 

pits. 

	 A piece of equipment used to handle edible product has an external surface 

(nonfood contact) with an exposed bolt and open seam that have a build-up 

of encrusted product residue around and in them. 

	 A polyester conveyor belt that moves exposed product to the packaging 

machines has two deep cuts and has been gouged. 

	 The plastic cutting boards on the pork boning tables have been scored by 

hand knives and have wizard knife gouges. 

	 A stainless steel shovel used to handle edible product has a rough and curled 

edge. 

	 An accumulation of product residue is under the edges of the floor mounts for 

the legs of three large permanently installed cooking kettles. 

●		 A foul odor emitted from a gearbox on a piece of equipment. 

**************************************************************************************** 

§416.3(b) Equipment and utensils must not be constructed, located, or 

operated in a manner that prevents FSIS program employees from 

inspecting the equipment or utensils to determine whether they are in 

sanitary condition. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Equipment and utensils are designed, constructed, installed, and operated in 

a manner that allows inspection personnel access to inspect them. Because 

of the closed nature of CIP systems, there should be inspection openings 

through-out the system so the IPP can verify that all parts have been cleaned 

and sanitized. 

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	 Conveyor guides, splash guards, safety guards etc., that are installed on 

equipment that cover food-contact surfaces can be removed to permit 

inspection. 

►Verifying Compliance with This Regulation 

IPP should examine and assess equipment and utensils used to prepare and 

handle edible product in one or more areas of the establishment. IPP should 

verify that the construction, location, or operation of the equipment and utensils 

does not prevent or impede inspection tasks. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are equipment or utensils constructed, located, or operated in a manner 

that prevents inspection program personnel from inspecting the 

sanitary condition of the equipment or utensils? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for equipment and utensils whose construction or installation interferes 

with sanitation inspection. 

	 Look for equipment and utensils with nonfood contact surfaces that are not 

accessible for inspection. 

	 Look for equipment and utensils with food-contact surfaces that are not visible 

for inspection. 

2.	 Assess the Information IPP Gathered. 

If IPP cannot visually inspect the surfaces or parts of equipment, IPP cannot 

determine if an insanitary condition is being created or if product is being 

contaminated. 

Scenario 

You find that a section of the establishment’s CIP piping system is not 

disassembled for inspection and it does not have access points for you to inspect 

the interior surfaces for cleanliness. At this point, you do not know if the piping is 

not clean, but there is noncompliance with the requirements of 416.3(b) so you 

should document this noncompliance on an NR. 

Inspection Methods	 11-81 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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The establishment installs quick disconnects and removable elbows at each 

change of direction to allow inspection. You ask the establishment to disconnect 

the pipes for inspection and a solution of water pours out of them. Now you will 

have to gather more information and make the determination whether or not this 

condition is creating an insanitary condition or contaminating product. 

Examples of the failure to meet the requirements for this regulation are: 

	 A splash guard is permanently installed on a portable screw conveyor that 

carries trimmings to a meat grinder hopper that prevents the IPP from 

inspecting the sanitary condition of the auger. 

	 A large piece of equipment is installed so close to the wall that the IPP cannot 

inspect the sanitary condition of one side of it. 

**************************************************************************************** 

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

material and construction that their use will not result in the adulteration of 

any edible product or in the creation of insanitary conditions. Such 

receptacles must not be used for storing any edible product and must bear 

conspicuous and distinctive marking to identify permitted uses. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Containers or receptacles for handling, storing, and transporting inedible 

materials are made of materials that do not create an insanitary condition. 

	 Inedible receptacles or containers are maintained in a good state of repair 

and cleaned as needed to avoid creating insanitary conditions. Containers 

that are not watertight or that leak can spread contaminants into the 

environment, which could become a source of contamination of product, 

equipment, and utensils. 

	 The permitted use of the receptacle or container is identified through 

conspicuous and distinctive markings, a color-coding system, or some other 

means. Simply put, establishment employees need to be able to recognize 

the inedible product containers from the edible product containers. 

	 Inedible receptacles or containers are not used to handle, store, and transport 

edible product. 

Inspection Methods	 11-82 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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►Verifying Compliance with This Regulation 

IPP should examine and assess inedible receptacles in one or more areas of the 

establishment. IPP should verify that receptacles or containers are clearly 

marked or identified, and constructed and used in a sanitary manner. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are receptacles used for storing inedible products marked 

conspicuously and distinctively to identify permitted uses?
 

Are receptacles used for storing inedible material constructed of
 

materials that can be maintained in a sanitary manner?
 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

 Look for proper identification on the inedible material receptacles. 

 Look for inedible receptacles made of materials that cannot be cleaned. 

 Look for inedible receptacles that are not watertight or are leaking. 

 Look for inedible receptacles that are giving off objectionable odors. 

 Look for inedible receptacles that are used to handle, store, and transport 

edible product. 

2.	 Assess the Information Gathered by IPP. 

If IPP find inedible containers that are not clearly marked or readily 

distinguishable from edible product containers, it would represent 

noncompliance with §416.3(c). 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information surrounding their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Inspection Methods	 11-83 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to inedible receptacles or containers that is 

creating an insanitary condition, there is noncompliance with the requirements of 

416.3(c) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe a plastic trash can marked “inedible” in the cooler being used to 

store edible bologna rework (stick ends and broken slices). You take an official 

control action and retain the bologna rework. To salvage the rework, the 

establishment must demonstrate that the rework is not contaminated. Even if the 

establishment is able to demonstrate that the rework is not contaminated, there is 

still noncompliance with the requirements of 416.3(c) and you should document 

this noncompliance on an NR using the appropriate SPS regulations. If the 

establishment cannot demonstrate that the rework is not contaminated, you 

would document this noncompliance under the SSOP task. 

Examples of the failure to meet the requirements of this regulation are: 

	 There is a hole in the bottom of an inedible container allowing purged juices 

(blood, water, etc.) to leak onto the production room floor. 

	 Several metal inedible product barrels located in production-related areas 

have a large build-up of dried, encrusted product residue on the inside 

surface and are emitting an objectionable odor. 

**************************************************************************************** 

§416.4 Sanitary Operations 

Frequent and effective cleaning of certain areas of the establishment is 

necessary to (1) prevent the accumulation of organic wastes resulting from meat 

Inspection Methods	 11-84 
 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

and poultry operations on equipment and utensils, (2) prevent the development 

of foul odors that could attract insects, rodents, and other vermin, and 

(3) remove product debris or dirt on nonfood-contact surfaces that may provide 

an environment suitable for the growth of microorganisms that employees could 

indirectly transfer to product. The method, frequency, and area to be cleaned 

may vary with establishment operations. 

§416.4(a) All food-contact surfaces, including food-contact surfaces of 

utensils and equipment, must be cleaned and sanitized as frequently as 

necessary to prevent the creation of insanitary conditions and the 

adulteration of product. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Utensils and equipment surfaces that contact exposed edible product are 

cleaned and sanitized on a schedule that prevents the creation of insanitary 

conditions and the adulteration of product. 

	 Food-contact surfaces of utensils and equipment are cleaned and sanitized 

whenever there is a change from working with raw product or raw 

components to working with ready-to-eat products. 

	 Food-contact surfaces of utensils and equipment are cleaned and sanitized 

whenever they become contaminated during operation. 

Note: Many establishments will comply with the requirements of §416.4(a) 

through SSOP activities. Generally, establishments clean their operations once 

a day, however, some establishments conduct chemical cleanup procedures less 

than once a day. These extended cleanup procedures should be incorporated 

into the establishment’s SSOP. To ensure that extended cleanup procedures 

prevent insanitation and the adulteration of product, establishments might 

conduct microbiological testing to evaluate the effectiveness of the extended 

cleanup. If IPP have concerns about the establishment’s frequency for cleaning 

and sanitizing food-contact surfaces IPP should confer with the Policy 

Development Staff (PDS). 

An example of failure to meet this performance standard is insufficient cleaning 

of a belt allowing a build-up of fat. When the fat rubs against a stainless steel 

guard on the belt, a black substance is deposited on the accumulated fat. 

Inspection Methods	 11-85 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Based on the regulatory requirements of 9 CFR 417.2(a)(2) and 9 CFR 

417.5(a)(1), FSIS believes that the results of testing and monitoring activities 

related to the production of product are subject to FSIS review and must be 

available to FSIS personnel upon request. These monitoring and testing records 

should be available to FSIS whether or not these activities are listed in the 

HACCP plan or hazard analysis. These records include, but are not limited to, all 

records, results, and supporting documentation associated with each HACCP 

plan, records, results, and supporting documentation associated with each 

procedure or prerequisite program, testing conducted for the establishment’s 

business customers, aerobic plate count testing, and total plate count testing. 

The IPP should be aware of all monitoring and testing conducted by the 

establishment and should ask establishment management to share the data that 

is generated by this monitoring and testing. The IPP should review the results 

when performing the Hazard Analysis Verification (HAV) task, the HACCP 

verification task, or the Review Establishment Data task. When reviewing 

records, results, and supporting documentation associated with testing, 

monitoring, and verification activities that are from procedures or prerequisite 

programs outside the HACCP plans, IPPs should not apply the same criteria as 

they would when verifying the regulatory requirements of HACCP plans. For 

example, these records associated with monitoring and testing may include 

occasional instances of less than perfect control without resulting in threat to 

product safety. However, records generated from these programs must continue 

to support the decisions made in the establishment’s hazard analysis. 

IPP should assess the testing results and monitoring results to verify the overall 

effectiveness of the procedures or programs. IPP should verify that if there is 

information in the records that requires the establishment to reevaluate the 

effectiveness of the Sanitation SOPs or reassess its HACCP plan, the 

establishment has done so. If the establishment has gathered information that 

indicates the Sanitation SOPs are no longer effective in preventing direct 

contamination or adulteration of product, there is noncompliance with 9CFR 

416.14. If the establishment has gathered information that indicates the HACCP 

plan should be reassessed and has not done so, there is noncompliance with 9 

CFR 417.4. 

If IPP have concerns about the design or results from testing, procedures or 

programs, IPP can contact the PDS or an EIAO through supervisory channels. 

The EIAO needs to conduct a comprehensive food safety assessment in the 

establishment to verify that the design of the food safety systems in operation 

meet regulatory requirements. 

Inspection Methods 11-86 
 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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If the establishment does not provide IPP with these records when they are 

requested, IPP should document this as noncompliance with the requirements 

specified in 9 CFR 417.5(a)(1) or as per FSIS Directive 5000.1 Rev. 4. 

**************************************************************************************** 

§416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils 

used in the operation of the establishment must be cleaned and sanitized 

as frequently as necessary to prevent the creation of insanitary conditions 

and the adulteration of product. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that nonfood-contact surfaces 

of facilities, equipment and utensils are cleaned and sanitized at a frequency that 

will prevent the accumulation of dust, dirt, product residue, and other debris that 

could create insanitary conditions and adulterate product. 

Note: During the normal course of operations exposed meat and poultry product 

should not come into contact with nonfood-contact surfaces such as the floor; 

posts, walls, door jambs, and other fixed parts of the building; flexible plastic 

strips or curtains on doors; or the inside surfaces of truck trailers. Nevertheless, 

the cleaning of the facilities is an important measure ensuring the protection and 

sanitary preparation of product. Unclean noncontact surfaces can cause 

sanitation problems by attracting vermin or by promoting the growth and 

reproduction of microbes. These microbes may spread to the exposed product 

areas in air currents, on employee clothing, on utensils or equipment, or cause 

odors that spread to the exposed product areas in air currents. A regular 

cleaning schedule should be established and followed to maintain nonfoodcontact surfaces of the facility in a clean and sanitary manner. 

►Verifying Compliance with this Regulation 

IPP should observe and assess the cleanliness of nonfood-contact surfaces in 

one or more areas of the establishment. IPP should verify that nonfood-contact 

surfaces in production related areas have been cleaned at a frequency 

necessary to preclude the build-up of soil residues. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are nonfood-contact surfaces of facilities, equipment, and utensils in 

the establishment cleaned and sanitized as necessary to prevent the 

creation of insanitary conditions and the adulteration of product? 

Inspection Methods	 11-87 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for the accumulation of dried or encrusted product residue from the 

previous days’ production on the underside and legs of equipment, e.g., 

conveyors, work tables, platforms, hand trucks, kettles, blenders. 

	 Look for the build-up of product residue, dust, and debris in hard-to-clean 

areas such as a wall behind a large piece of equipment, mounted cabinets, or 

electrical boxes in edible product areas. 

	 Look for posts, doors, doorjambs, rail switch pulls, and other fixed parts of the 

building coated with fat and meat juices from previous days’ production. 

	 Look for accumulations of dust and rust on overhead pipes, rails, ducts, wires, 

lights, and any other overhead structures in edible product areas. 

	 Look for accumulations of product residue, trash, dust, or debris on the floors 

in production rooms, coolers, freezers, and ingredient dry storage areas. 

	 Look for accumulations of rubbish, trash, dust, or debris on the floor in 

lunchrooms and break rooms, and of packaging material in dry storage areas. 

	 Look for a build-up of black tar-like residues from previous days’ smoke 

cycles on the ceiling, walls, and smoke ducts of smokehouses. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information surrounding their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the cleanliness of nonfood-contact surfaces of 

facilities, equipment, and utensils that is creating an insanitary condition, there is 

noncompliance with the requirements of §416.4(b) and IPP should document that 

noncompliance on an NR. If the conditions IPP observed are not creating an 

insanitary condition or adulteration of product, there is no noncompliance. 

Inspection Methods	 11-88 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe a rail in the carcass cooler with an accumulation of rust on it. Beef 

sides are stored directly under the rusted area on the rail. You decide to examine 

the hock and round area of several sides of beef. You find numerous black 

specks on one side and a few black specks on the other sides of beef. Because 

product was contaminated by flaking rust, you should document this 

noncompliance using the appropriate SSOP regulations. 

If you did not find rust specks on the sides of beef when you examined them, 

there is still noncompliance with the requirements of 416.4(b) because the rail 

was not maintained and cleaned at frequency to prevent the build-up of rust. 

Examples of the failure to meet the requirements for this regulation are: 

	 There is mold growing on a wall in an edible product area. 

	 There are meat and fat particles from previous days’ use on the underside of 

a product transfer belt. 

	 There is an accumulation of food particles, trash, and dust under the vending 

machines in the cafeteria. 

**************************************************************************************** 

§416.4(c) Cleaning compounds, sanitizing agents, processing aids, and 

other chemicals used by an establishment must be safe and effective under 

the conditions of use. Such chemicals must be used, handled, and stored 

in a manner that will not adulterate product or create insanitary conditions. 

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

processing environment must be available to FSIS inspection program 

employees for review. 

Inspection Methods	 11-89 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Meat and poultry products are not contaminated or adulterated through the 

misuse of proprietary substances and nonfood compounds. 

	 All proprietary substances and nonfood compounds are safe for their intended 

use and used, handled, and stored to prevent the creation of insanitary 

conditions. 

	 Documentation substantiating safe use of a chemical in a food-processing 

environment is available for FSIS review. 

Safety Documentation 

Safety documentation can vary with the nature and intended use of the chemical. 

Some chemicals must meet certain requirements set forth by other Federal 

Agencies. For example, sanitizers used on food-contact surfaces and some
 

lubricants used in food processing areas must meet the Food and Drug
 

Administration (FDA) requirements. The establishment should have
 

documentation showing that the compound complies with the relevant FDA 

regulations (21 CFR §178.1010 or §178.3570). Sanitizers meeting FDA 

requirements are usually identified as "Food Grade."
 

The use of many chemicals is not approved by any Federal agency. In this case, 

the establishment may have a Safety Data Sheet (SDS), label, use
 

instructions, or a letter of guaranty from the manufacturer to substantiate the
 

safety of the chemical when used in a food-processing environment.
 

IPP may see documentation in the form of a statement that the chemical was 

previously approved by FSIS and listed in the old USDA List of Proprietary
 

Substances and Nonfood Compounds Book. IPP can accept this statement as 

proof that the chemical and its use are safe as long as the chemical’s formulation 

and use has not changed since the book was printed. 

►Verifying Compliance with This Regulation 

IPP should observe and assess the use, handling, and storage of proprietary 

substances and nonfood compounds in one or more areas of the establishment 

and review establishment documentation that supports the safety of their use in 

the food processing area. IPP should verify that these chemicals are used, 

handled, and stored in a manner that does not create insanitary conditions or 

Inspection Methods	 11-90 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

adulterate product and that documentation describing the safe use of the 

chemical is on file in the establishment. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are cleaning compounds, sanitizing agents, processing aids, and other 

chemicals used by the establishment safe and effective under the 

conditions of use? 

Does the establishment have documentation substantiating the safety 

of a chemical’s use in a food-processing environment? 

The following list of observations may assist IPP in answering these questions. 

IPP may perform additional observations. 

	 Look for proprietary substances and nonfood compounds used in a manner 

that is inconsistent with their label instructions and precautions. 

	 Look for clear identification (labeled name of the compound) on containers 

used to store, dispense, or transport amounts of nonfood compounds (e.g., 

cleaners and sanitizers) that have been removed from their original fully 

labeled (bulk) container. 

	 Look for proprietary substances and nonfood compounds stored directly 

above or adjacent to (commingled with) food ingredients or productpackaging materials. 

	 Look for containers that held toxic materials used to handle, store, or 

transport edible product or food ingredients. 

	 Look for documents that support the safety of a substance or compound used 

in the food-processing environment. 

2.	 Assess the Information Gathered by IPP. 

When the establishment has no documentation on file to support the safety of a 

proprietary substance and nonfood compound that is used in the facility, there is 

noncompliance with §416.4(c). 

When IPP find one of the other conditions listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

Inspection Methods	 11-91 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to use, handling, and storage of chemicals that 

is creating an insanitary condition, there is noncompliance with the requirements 

of 416.4(c) and IPP should document that noncompliance on an NR. If the 

conditions IPP observed are not creating an insanitary condition or adulteration 

of product, there is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe an employee preparing a solution of quaternary ammonium 

sanitizer to be applied to the blades of the slicers and surfaces of the conveyor 

belts that move sliced product to the packaging machine. The employee removes 

a cup (8 oz.) of the sanitizer from a gallon container and adds it to a two gallon 

spray bottle filled with water. You review the general use instructions that are 

printed on the one-gallon container of sanitizer. The instructions state “to attain a 

200 ppm dilution, add 8 oz of sanitizer to 4 gallons of water.” The label also 

states that treated equipment does not need to be rinsed with potable water. In 

past observations, you have not seen the establishment rinse the blades of the 

slicers or conveyor belts with potable water after treatment with the sanitizer. You 

inform management of their observation. A management official discards the 

sanitizer solution and correctly mixes another solution of sanitizer. At this point, 

you do not know for a fact that product has been adulterated. 

You have seen the employee that mixed the sanitizer applying it to the 

equipment before. Therefore, you are concerned that the sanitizer may have 

been previously misused. Chemical sanitizers used in excessive amounts can be 

harmful if they end up in food. You conclude that you are unable to determine 

that the establishment has not produced adulterated product. You ask 

Inspection Methods 11-92 
 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

establishment management to demonstrate that adulterated product has not 

been produced. 

Examples of the failure to meet the requirements for this regulation are: 

	 The establishment’s documentation that is kept on file to support the safety of 

the substances and compounds used in the facility is not available to the IPP 

upon request. 

	 A five-gallon container of liquid cleaning agent is stored on a rack directly 

above bags of salt in the ingredient dry storage area. 

	 There are several containers with a chemical solution in them stored in the 

dry storage area without any identification on the container. 

**************************************************************************************** 

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

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

official establishments. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Product is not contaminated or adulterated by elements in the environment 

such as microorganisms, dust, wood splinters, scaling paint, flaking rust, 

condensate, oil, grease, metal fragments, plastic, etc. 

	 Products are not adulterated or misbranded because they contain undeclared 

ingredients that are potential sources of food sensitivities and intolerances 

(i.e., allergens). 

	 Products are protected from being contaminated by dust, dirt, or insects 

during loading, unloading, and transportation from the establishment. 

	 No handling or storing of nonfood materials (barrels, boxes, pallets, trash, 

etc.) creates insanitary conditions in areas where product is prepared, 

handled, or stored. 

	 Supplies such as packaging materials or paper wrappings that might contact 

edible products are handled and stored under sanitary conditions, e.g., 

measures are taken to prevent dust collection, footwear contamination, 

cleanup water splash, or contact with any insanitary surface. 

Inspection Methods	 11-93 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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	 Wet cleaning operations are conducted in a manner that minimizes the 

danger of contaminating product or food-contact surfaces with splashes from 

cleanup water. The establishment should have a separate area or washroom 

for cleaning utensils, pans, trays, hand trucks, demountable equipment, etc. 

	 Employee traffic patterns do not create insanitary conditions or lead to the 

cross-contamination of product. Pathogens can be transported by employee 

clothing or boots. Therefore, employees not routinely assigned to specific 

work areas should not travel through those work areas. For example, 

employees working in the inedible product department should not travel 

through edible product areas. 

Similarly, employees that work in slaughter areas or raw product areas should 

not travel through cooked or ready-to-eat product areas. 

Note: Depending upon the situation and the circumstances, the establishment 

must decide how to protect the product through all phases of the process. For 

example, the establishment may decide to cover all product that is stored in the 

finished product freezer with plastic to prevent condensate from soiling the boxes 

while it is working to fix the refrigeration system in the freezer. 

This performance standard allows establishments to devise their own means of 

limiting microbial growth in their processing operations. The establishment may 

control microbial growth in product by using the traditional method of reducing 

the ambient temperature or use a different method. For instance, the 

establishment may use heat exchangers on equipment to immediately reduce 

product temperature, which more effectively limits the growth of microorganisms 

than maintaining a specific room temperature. 

►Verifying Compliance with This Regulation 

IPP should observe the preparation and handling of product at one or more 

points or steps in the production process. IPP should verify that product is 

protected from sources of contamination as it moves through the process. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Does the establishment protect product from adulteration during 

processing, handling, storage, loading and unloading, and during 

transportation from official establishments?
 

Inspection Methods	 11-94 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for inadequate sanitation between production runs of products that have 

ingredients that cause food sensitivities declared on their label and products 

that do not have these ingredients declared on their label. 

	 Look for raw (not rinsed or washed) vegetables being handled in the same 

area as exposed edible product. 

	 Look for cloth or paper containers of meat or poultry or of ingredients (sugar, 

salt and spices, etc.) added to equipment (mixers, blenders, grinders, etc.) 

that allows lint, dirt, or debris from the outer surface to fall into product. 

	 Look for supplies that might contact product that are not handled and stored 

in a manner to preclude contamination 

	 Look for food ingredients that are not handled and stored in a manner to 

preclude contamination, e.g., spices stored in containers without lids in the 

spice room, open broken bags of ingredients in the dry storage area, etc. 

	 Look for products (carcasses or carcass parts, trimmings in combo-bins or 

gondolas, etc.) received and distributed from the establishment that are not 

protected from dust, dirt, insects, etc. 

	 Look for transport vehicles that are not constructed to protect product being 

hauled from weather or road contamination. 

	 Look for containers (wooden, fiberboard, or metal) reused as edible product 

containers that are structurally unsound or not clean, e.g., torn, broken or wet; 

soiled or stained; give off odors; or contain meat and fat particles, wood 

splinters, and any other foreign material. 

	 Look for transport vehicles that give off objectionable odors or that have 

accumulations of dried meat and fat or foreign materials such as grease and 

trash in them. 

	 Look for pallets in edible product areas that have a build-up of grease, meat 

tissues and juices, animal excreta, feathers, or hair, or are giving off offensive 

odors. 

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Sanitation Performance Standards 

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	 Look for accumulations of rubbish such as paper towels, empty product 

cartons, or labeling materials in edible product areas. 

	 Look for employees traveling through areas of the establishment where they 

are not assigned. 

2.	 Assess the Information Gathered by IPP. 

When IPP find one of the conditions listed above, IPP should assess all of the 

information related to their observation and then make a determination whether 

the establishment is meeting the regulatory requirements. IPP should use good 

judgment in making these determinations and might seek answers to the 

following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to the processing, handling, storage, loading and 

unloading, and transportation of product that is creating an insanitary condition, 

there is noncompliance with the requirements of §416.4(d) and IPP should 

document that noncompliance on an NR. If the conditions IPP observed are not 

creating an insanitary condition or adulteration of product, there is no 

noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe an employee preparing a pickle cure solution. The pickle 

ingredients are staged on a wooden pallet next to the stainless steel pickle cure 

vat. The employee fills the vat up with water and then begins to add 50 lb bags 

of salt to the water. He stands the bag on end, opens the top of the bag of salt, 

picks it up, places it on the rim of the vat with the bag over the edge, and pours 

the salt from the bag. Since the bags of salt were in direct contact with the pallet 

and he did not strip the outer layer of the bag before placing it over the edge of 

the vat, you decide to examine the condition of the solution. You find extraneous 

Inspection Methods	 11-96 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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material (lint, dust, debris, etc.) floating on top of the water. Because a product 

ingredient was contaminated, you should document this noncompliance using the 

SSOP regulations. If you did not find foreign or extraneous material in the 

solution when you examined it, there is still noncompliance with the requirements 

of 416.4(d) because the method the employee used to add the salt when 

formulating the pickle solution does not protect the solution from contaminants 

that may fall off the outside surface of the bags. You should document this 

noncompliance on an NR using the appropriate SPS regulations. 

Examples of the failure to meet the requirements for this regulation are: 

	 The establishment is loading forequarters of beef onto a truck trailer that has 

an accumulation of dried blood, fat, and meat particles on the floor. 

	 Several overhead pipes in the grinding room have an accumulation of dust on 

them. 

	 Several uncovered combo bins of pork trimmings were removed from a truck 

trailer and are now sitting on the receiving dock waiting to move into the 

cooler. The receiving dock is open to environmental elements. 

	 The surface of a roll of packaging material that contacts product is stored in 

direct contact with the surface of a pallet in the dry storage area. 

	 Two employees who work in the picking room are walking through the cut-up 

room. 

	 Combo bins of raw pork products are stored in racks three tiers high in the 

cooler. Two combo bins of pork bellies stored on the bottom tier were not 

covered. 

**************************************************************************************** 

§416.5 Employee Hygiene 

Employees can be disease carriers and bring contaminants from the outside 

such as dirt, debris, and other foreign materials that can both directly and 

indirectly contaminate food. Foodborne illness outbreaks have been linked to 

poor personal hygiene of workers involved in food processing and handling. 

Therefore, personal hygienic practices for employees are essential to the 

production of safe and wholesome meat and poultry products. The performance 

standard allows establishments to develop alternative or innovative means to 

ensure that employee practices do not result in insanitary conditions or 

adulteration of product. 

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§416.5 (a) Cleanliness. All persons working in contact with product, foodcontact surfaces, and product-packaging materials must adhere to 

hygienic practices while on duty to prevent adulteration of product and the 

creation of insanitary conditions. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that employees are engaging 

in personal hygienic practices and product handling practices that prevent 

insanitary conditions and reduce the likelihood of contaminating product, foodcontact surfaces, and product-packaging materials. 

Note: The hands can serve as a vehicle for transferring microorganisms to meat 

and poultry products, food-contact surfaces of equipment, and packaging 

materials. The hands can pick up microorganisms from such actions as touching 

utensils, equipment, raw product, product cartons, pallets, and door handles; 

using the toilet; eating; shaking hands; and touching the nose, mouth, or face. 

For example, many people have the pathogen Staphylococcus aureus in their 

nasal passages and can transfer these organisms to their hands by touching or 

blowing their nose. 

Handwashing is a very important practice in a food-processing environment. 

Establishment employees that handle any edible product should keep their hands 

clean. Insanitary personal practices like indiscriminate and uncovered coughing 

and sneezing over exposed product, and wiping discharges from the eyes, nose, 

or mouth on outer clothing could result in product contamination. 

Employees using poor food handling techniques can contaminate product and 

food-contact surfaces with perspiration, hair, cosmetics, tobacco/snuff, chewing 

gum, and foreign objects like jewelry. Pieces of the jewelry such as the setting or 

stones or the whole item itself, like a wristwatch, might fall into the product being 

prepared. Some jewelry may have crevices or recesses that can collect product 

residue and hinder routine cleaning. As a result, the jewelry can act as a 

reservoir of microorganisms that can be transferred to product. 

FSIS has the authority to take action against any unhygienic practice that could 

result in insanitary conditions or adulterated product. This includes handling 

procedures that might contaminate edible products or create insanitary 

conditions. 

Inspection Methods 11-98 
 

 

 

 

 

 

 

 

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►Verifying Compliance with This Regulation 

IPP should observe and assess employees working in contact with product, 

food-contact surfaces and product packaging materials in one or more areas 

of the establishment. IPP should verify that employees are engaging in personal 

hygienic practices and product handling practices that minimize the possibility of 

transferring microorganisms and other contaminants to product, food-contact 

surfaces, and packaging materials. 

1. IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are the persons in contact with product, food-contact surfaces, and 

product packaging materials adhering to hygienic practices? 

The following list of observations may assist IPP in answering this question. IPP 

may perform additional observations. 

	 Look for employees who do not wash their hands or change gloves after 

touching a contaminated surface (e.g., pallet; box; head, nose, mouth, or 

other areas of the body). 

	 Look for employees engaging in insanitary personal practices such as 

uncovered coughing over exposed product or wiping discharges from their 

nose or mouth on their outer clothing. 

	 Look for employees using their mouth to temporarily hold metal tag fasteners, 

shroud pins, cards, or other objects, etc., that will be handled subsequently by 

the employee or contact product. 

	 Look for employees who have handled raw product or raw components who 

do not wash and sanitize their hands prior to handling ready-to-eat products. 

Note: The establishment may include hygienic handling procedures for 

preventing cross-contamination of ready-to-eat products in its SSOP. When the 

establishment includes these procedures in the SSOP, management must 

implement and monitor such procedures and document the monitoring results, 

including any corrective actions taken on the SSOP records. In this case, IPP 

should verify compliance with the regulatory requirements while performing the 

SSOP task. 

Inspection Methods	 11-99 
 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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	 Look for employees handling products or components who are wearing loose 

jewelry such as wristwatches and bracelets, and rings with settings or high 

crowns. 

	 Look for employees who do not wash their hands after using the toilet room, 

eating, or smoking prior to handling product or implements used in the 

preparation of product. 

	 Look for employees who are not preventing dislodged hair, perspiration, or 

cosmetics from either falling into or ending up in the product. 

	 Look for employees eating and using tobacco products in nondesignated 

areas of the establishment. 

	 Look for employees who do not remove aprons, outer garments, scabbards, 

knives, steels, etc., before using the toilet or urinal. 

2.	 Access the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to employee cleanliness that is creating an 

insanitary condition, there is noncompliance with the requirements of 416.5(a) 

and IPP should document that noncompliance on an NR. If the conditions IPP 

observed are not creating an insanitary condition or adulteration of product, there 

is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Inspection Methods	 11-100 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Scenario 

You observe the employee who places frozen blocks of beef trimmings into the 

hydroflaker pick up several empty beef trimming cartons off the floor (touching 

the outside surface of the carton with his hands) and put them in a trash bin. You 

watch to see if the employee realizes he has touched an unclean surface. The 

employee does not attempt to wash his hands and continues to perform the 

same work duties. At this point, there is noncompliance with §416.5(a) because 

an insanitary condition exists that could lead to direct product contamination and 

you would document this noncompliance on an NR using the appropriate SPS 

regulation. However, if the employee eventually touches one of the frozen blocks 

of beef trimmings with his hands prior to washing them, product would be 

contaminated. If the establishment can demonstrate there was no food safety 

hazard associated with the contamination, you would document this 

noncompliance using the appropriate SSOP regulations. 

Scenario 

You see an employee leave the restroom without washing his hands. 

Careful consideration of the circumstances is required when it is not known for 

a fact that an employee’s hands will serve as a vehicle for cross-contamination 

of product. In cases where an employee has engaged in a nonwork activity like 

using the toilet, smoking, or eating, further investigation or observation may be 

necessary before you conclude that an insanitary condition exists. 

It is reasonable to conclude that the employee’s hands touched an unclean 

surface when he used the toilet. However, if the employee does not return to the 

production room, then the employee’s unclean hands do not create an insanitary 

condition that could result in contaminated product or food-contact surfaces. 

Likewise, if the employee washes his hands at a sink immediately upon entering 

the production room, then his hands were cleaned prior to handling product or 

touching a food-contact surface. However, if the employee goes directly to his 

workstation and does not wash his hands, his poor personal hygienic practice 

creates an insanitary condition and there is noncompliance with §416.5(a) 

because his hands might transfer contaminants to products or a food-contact 

surface. You would document this SPS noncompliance on an NR. 

Examples of the failure to meet the requirements for this regulation are: 

	 An employee handling exposed product with her bare hands is wearing nail 

polish. 

	 An employee wipes his runny nose on the sleeve of his smock. 

Inspection Methods	 11-101 
 

 

 

 

 

 

 

 

 

 

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	 Two employees handling exposed product are not taking measures to prevent 

their hair from falling into product. 

	 An employee adding pork trimmings into grinders is wearing a wristwatch. 

**************************************************************************************** 

§416.5(b) Clothing. Aprons, frocks, and other outer clothing worn by 

persons who handle product must be of material that is disposable or 

readily cleaned. Clean garments must be worn at the start of each working 

day and garments must be changed during the day as often as necessary 

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

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 The outer clothing (aprons, frocks, smocks, garments, etc.) worn by 

employees handling product is either made of a disposable material or a 

readily cleanable material. 

	 Employees handling product wear clean outer clothing (free of visible product 

residues and other soiling matter) at the beginning of operations. 

Note: These regulations do not require establishment employees to wear frocks 

or smocks. The outer clothing the employee is wearing at the start of the day 

must be clean. Outer clothing that is not made of a material that can be washed 

or laundered to remove product residues and other soiling matter (e.g., dirt and 

grease) or has not been laundered or washed between operations can harbor 

disease-causing microorganisms and other contaminants. Employees that wear 

soiled outer clothing when production begins may touch their clothing and 

contaminate their hands or contaminate product through direct contact with the 

dirty or soiled clothing. 

	 Employees handling product change their frock, smock, garment or outer 

clothing as needed during the day. For instance, employees change their 

frocks, smocks, garments, or outer clothing whenever it becomes 

contaminated. Employees working in departments where there is routine 

contact between product and outer clothing (employees boning carcasses, 

employees moving trimmings in luggers, etc.), change their garments and 

cloth (cotton) gloves (if worn) at a frequency that prevents the build-up of 

microorganisms. 

Inspection Methods	 11-102 
 

 

 

 

 

 

 

 

 

 

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	 Employees change their outer clothing, frocks, smocks, garments, etc., when 

they go from raw product areas to ready-to-eat product areas to prevent the 

possible cross-contamination of ready-to-eat products with pathogenic 

bacteria associated with raw product. 

►Verifying Compliance with This Regulation 

IPP should observe and assess employees handling product in one or more 

areas of the establishment. IPP should verify that employees wear disposable or 

cleanable outer clothing, that they are wearing clean outer clothing at the 

beginning of the shift, and that they change their outer clothing as often as 

needed to prevent insanitary conditions or adulteration of product. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Questions. 

Are aprons, frocks, and other outer clothing worn by persons who 

handle product made of material that is disposable or readily cleaned? 

Are clean garments worn at the start of the day and changed during the 

day as often as necessary? 

The following observations may assist IPP in answering these questions. IPP 

may perform additional observations. 

	 Look for employees wearing outer clothing that is not disposable or made of a 

material that is not readily cleaned. 

	 Look for employees wearing dirty or soiled frocks, smocks, garments, or other 

outer clothing at the start of operations. 

	 Look for employees who do not change their frocks, smocks, garments, or 

other outer clothing when they have touched a contaminated surface. 

	 Look for employees who do not change their frocks, smocks, garments, or 

other outer clothing as needed during the day. 

	 Look for employees who do not change their frocks, smocks, or outer 

garments when they go from raw product areas to ready-to-eat product areas. 

Inspection Methods	 11-103 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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2. Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to employee clothing that is creating an 

insanitary condition, there is noncompliance with the requirements of 416.5(b) 

and IPP should document that noncompliance on an NR. If the conditions IPP 

observed are not creating an insanitary condition or adulteration of product, there 

is no noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You see an employee who is cutting beef primal parts into steaks pick a wooden 

pallet up off the floor, place it under his arm against his side, drag it the to the 

wall next to the cutting table, and rest it against the wall. The employee 

immediately goes to the hand wash sink and washes his hands but he does not 

change his frock. The inner portion of employee’s frock sleeve that contacted the 

pallet has contacted product because it has product residue (bloodstains) on it. 

Because the employee’s frock sleeve touched an unclean surface, contaminants 

like microorganisms, wood splinters, dust, dirt, debris, etc., could be transferred 

to product when it comes in contact with the sleeve. There is noncompliance 

with the requirements of 416.5(b) and you should document that SPS 

noncompliance on an NR. 

Inspection Methods 11-104 
 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Examples of the failure to meet the requirements for this regulation are: 

	 An employee from the sausage stuffing area wearing a soiled smock entered 

the ready-to-eat product cooler. 

	 Two employees in the boning department have frocks with product residue 

from the previous day’s production on them at the start of operations. 

**************************************************************************************** 

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

infectious disease, open lesion, including boils, sores, or infected wounds, 

or any other abnormal source of microbial contamination, must be 

excluded from any operations which could result in product adulteration 

and the creation of insanitary conditions until the condition is corrected. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that no person affected with a 

disease in a communicable form, while a carrier of such disease, or while 

afflicted with boils, sores, infected wounds, or other abnormal sources of 

microorganism contamination, works in any area of the establishment where 

there is a likelihood of disease transmission or meat, poultry, or food ingredients 

becoming contaminated, until the condition is corrected. 

Note: A wide range of communicable diseases and infections may be transmitted 

by food handlers to other employees and consumers through contaminated meat 

and poultry products and careless handling practices. 

Foodborne pathogens may be shed from infected workers during the incubation 

period of a disease, before the affected person displays clinical symptoms. 

Employees working in edible product areas exhibiting flu-like symptoms such as 

persistent sneezing or coughing can contaminate exposed product, food-contact 

surfaces (hands, equipment, and utensils), and product packaging materials with 

discharges from the mouth and nose. 

Skin infections, such as boils, open lesions, and infected cuts, frequently contain 

large numbers of streptococci or staphylococci organisms that can easily become 

food contaminants. These infections may be sources of contamination that can 

lead to foodborne illness. 

IPP should be able to recognize obvious symptoms and lesions like those 

mentioned above. However, since IPP are not trained to diagnose 

Inspection Methods	 11-105 
 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

infectious diseases, if IPP have questions about an employee having an 

infectious disease, IPP should discuss this with establishment 

management. 

►Verifying Compliance with this Regulation 

IPP should observe and assess employees working in contact with product, 

food-contact surfaces, and product packaging materials in one or more 

areas of the establishment. IPP should verify that no employees have infectious 

diseases or open lesions such as boils or sores that could create insanitary 

conditions or adulterated product. 

1.	 IPP May Gather Needed Information by Seeking the Answer to the 

Following Question. 

Are persons who appear to have an infectious disease; an open lesion, 

including boils, sores, or infected wounds; or any other abnormal 

source of microbial contamination excluded from any operations that 

could result in product adulteration and the creation of insanitary 

conditions? 

The following observations may assist IPP in answering this question. IPP may 

perform additional observations. 

	 Look for employees who appear to be exhibiting symptoms of an infectious 

disease or condition. 

	 Look for employees with an open lesion, including a boil, sore, infected 

wound, or any other abnormal source of microbial contamination on their 

hands or forearms. 

2.	 Assess the Information Gathered by IPP. 

When IPP find conditions like the examples listed above, IPP should assess all of 

the information related to their observation and then make a determination 

whether the establishment is meeting the regulatory requirements. IPP should 

use good judgment in making these determinations and might seek answers to 

the following questions in order to determine if there is noncompliance. 

Are the conditions observed by IPP creating an insanitary condition? 

If IPP find any condition relating to employee health that is creating an insanitary 

condition, there is noncompliance with the requirements of 416.5(c) and IPP 

Inspection Methods	 11-106 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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should document that noncompliance on an NR. If the conditions IPP observed 

are not creating an insanitary condition or adulteration of product, there is no 

noncompliance. 

Are the conditions observed by IPP contaminating product? 

If product is contaminated, IPP might need to make a further assessment by 

seeking answers to more questions. Is there a food safety hazard associated 

with the contaminated product? If there is no food safety hazard associated with 

the product, IPP should document the noncompliance using the appropriate 

SSOP task and regulations. If there is a food safety hazard associated with the 

contaminated product, IPP should document the noncompliance using the 

appropriate HACCP verification task and regulations. 

Scenario 

You observe an employee working in the inedible product department exhibiting 

flu-like symptoms such as persistent sneezing or coughing. The inedible product 

department is separate from areas used for edible products. The establishment 

also has separate welfare facilities (toilet and dressing rooms, lunchrooms, etc.) 

for employees who work in the inedible product department. Since the 

employee’s potential health condition does not present a risk of transmitting 

foodborne pathogens to edible product, edible food-contact surfaces, and edible 

product packaging materials, there is not an insanitary condition. 

Scenario 

You observe an employee handling raw edible product with a cut on her 

forefinger near the first knuckle. The cut has some redness around it but you are 

not sure that it is infected. The cut is not protected with an impermeable cover. 

Because of the potential of transferring microorganisms to product, there is 

noncompliance with the requirements of §416.5(c) and you should document the 

SPS noncompliance on an NR. 

If the cut was infected (pus pockets and fluid oozing), then product would have 

been contaminated. If the establishment could demonstrate there was no food 

safety hazard associated with the contamination, you would document this 

noncompliance using the appropriate SSOP task and regulations. The 

establishment would probably not be able to support a claim that there is no food 

safety hazard associated with the contamination because of the possibility of 

transferring the pathogen Staphylococcus aureus to the exposed product; 

therefore, you would document the noncompliance using the appropriate HACCP 

verification task and regulations. 

Inspection Methods 11-107 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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Examples of the failure to meet the requirements for this regulation are: 

	 An employee who is handing exposed product has an uncovered sore on his 

bare forearm. 

	 An employee moving pallets of boxed product from the end of the production 

lines to the freezer appears to have a cold (exhibiting symptoms such as 

persistent coughing, sneezing, sniffling, etc.). 

Note: The regulatory requirements pertaining to employee hygiene also apply to 

the IPP. As a representative of a public health agency, it is imperative that IPP 

lead through example and follows all provisions in 9 CFR 416.3 and 416.5 during 

the performance of their official duties within federally inspected meat and poultry 

product establishments. If the establishment has requirements that are more 

stringent than the SPS requirements, e.g., hairnets must be worn by all 

employees working in production related areas or no items can be carried in 

frock pockets, IPP are expected to follow those requirements. 

INSANITARY CONDITIONS (CONTAMINATION) DURING SLAUGHTER 

Slaughter establishments must design and implement sanitary dressing 

procedures to prevent insanitary conditions and the contamination of carcasses. 

During slaughter incidental contamination may occur from substances not related 

to the species being slaughtered (e.g. oils, rail dust, condensate, and unidentified 

foreign material) or from substances related to the species being slaughtered like 

digestive content, milk, ingesta or bile. 

Incidental contamination does not automatically represent an insanitary 

condition. Even if there are observations of contamination on carcasses during 

the slaughter process, the establishment still has the opportunity to implement 

antimicrobial measures, e.g., knife trimming, steam vacuum, and acid/hot water 

rinses, that will address the contamination before the carcasses complete the 

slaughter process. Since the establishment has the opportunity to 

implement antimicrobial measures to address incidental contamination 

before the carcasses leave the slaughter process such contamination is 

not considered to be a failure of the establishment’s Sanitation SOP. 

IPP must assess the available information and evaluate each occurrence of 

incidental contamination to determine whether the establishment has failed to 

prevent the creation of insanitary slaughter conditions prior to carcasses 

completing the process. 

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Sanitation Performance Standards 

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When there is evidence that the establishment is not implementing its sanitary 

dressing procedures, or the procedures are ineffective in preventing the creation 

of ongoing insanitary conditions, off-line IPP are to cite appropriate regulations 

including relevant SPS regulations. 

Sanitary dressing will be covered in more detail later in the course. 

CUSTOM-EXEMPT FACILITIES 

§303.1a(2)(i) 

Establishments that conduct custom exempt operations must be 

maintained and operated in accordance with the provisions of §416.1 

through 416.6, except for §416.2(g)(2) through (6) of this chapter, regarding 

the water reuse and any provisions of Part 416 of this chapter relating to 

inspection or supervision of specified activities or other action by a 

program employee. If custom exempt operations are conducted in an 

official establishment, however, all of the provisions of Part 416 of this 

chapter shall apply to those operations. 

►Establishment’s Responsibilities 

The establishment has the responsibility to ensure that: 

	 Operations are conducted in a manner sufficient to prevent the creation of 

insanitary conditions. 

	 Conditions in and around the establishment do not lead to adulterated 

product. 

	 The requirements in §416.1 through §416.6, except those addressing water 

reuse, are met. 

Note: Custom operations conducted in official establishments are subject to all 

of 9 CFR Part 416 including implementing the SSOP per 9 CFR 303.1(a)(2)(i). If 

the official establishment includes its written procedure to remove, segregate, 

and dispose of SRMs in its SSOP, it must meet all the requirements of 9 CFR 

416, including SSOP recordkeeping for its custom operations. 

IPP should verify that custom exempt operations are maintained and operated in 

accordance with the SPS regulations. IPP should also follow the instructions in 

FSIS Directive 5930.1 Rev. 4. 

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Sanitation Performance Standards 

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COMPLIANCE GUIDELINES 

The Agency has compiled the Sanitation Performance Standards Compliance 

Guide as an industry guideline for meeting the sanitation performance standards. 

The guide presents methods that have historically proven to be effective in 

maintaining sanitary conditions in meat and poultry establishments such as past 

FSIS regulations and guidance, recommendations from the 2001 Food Code, 

and other technical sources. The guide is available electronically on the FSIS 

internet homepage 

(http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/SanitationGuide.htm). 

Establishments that follow the guidance in this document can be fairly certain 

that they are meeting the SPS requirements. However, since each processing 

environment is unique, in some cases the methods presented may be 

inadequate to ensure sanitary conditions. It is important to remember that 

guidance material is not regulatory requirements and inspection personnel 

should not take enforcement action if the establishment fails to comply with the 

methods contained in the guide. 

SPS REGULATIONS Workshop #3 

Multiple Choice Questions 

1.	 Which federal agency sets the standard for the number of toilet facilities 

required in the establishment? 

a.	 FDA 

b.	 OSHA 

c.	 FSIS 

d.	 EPA 

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2.	 According to the performance standard for dressing rooms, lavatories, and 

toilets, lavatories (handwash sinks) must be: 

a.	 Equipped with hot and cold running water, a supply of soap and towels, 

and located near toilet and urinal rooms and other places in the 

establishment as needed to ensure cleanliness of employees handling 

product. 

b.	 Conveniently located and equipped with hot and cold running water 

delivered through a mixing faucet with an outlet 12 inches from the rim of 

the bowl, to ensure employees wash their arms as well as hands. 

c.	 Equipped with hot and cold running water, a supply of soap and towels, 

and operated by a means other than with the hand, e.g., the knee or foot. 

3.	 How often must an establishment using a municipal water supply renew the 

water potability certificate? 

a.	 There is no mandatory renewal period. 

b.	 Every year. 

c.	 Twice a year. 

4.	 How often must an establishment using a private well as its water supply 

renew the water potability certificate? 

a.	 There is no mandatory renewal period. 

b.	 Every year. 

c.	 Twice a year. 

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5.	 Establishments can reuse water or solutions if: 

a.	 The establishment has a written water and solution reuse program on file. 

b.	 The establishment’s water and solution reuse program is approved by 

FSIS. 

c.	 The pipes carrying the reuse water or solution are clearly identified by 

name, colored tape, or other method acceptable to the IPP. 

d.	 The reuse of the water or solution does not adulterate product or create 

insanitary conditions. 

6.	 Equipment and utensils used for processing or otherwise handling edible 

product or ingredients must: 

a.	 Be made of stainless steel (series 300). 

b.	 Have their design and construction approved by FSIS or a third (outside) 

party before being used in the establishment. 

c.	 Be made of materials and constructed in a manner that facilitates 

thorough cleaning.
 

7.	 Which of the following statements regarding the sanitation performance 

standards is true? 

a.	 All chemicals used in the food- processing environment must be approved 

by a Federal Agency. 

b.	 Documentation substantiating the safety of a chemical's use in a foodprocessing environment must be available to FSIS for review. 

c.	 Extended cleanup procedures must have prior approval by FSIS. 

Inspection Methods	 11-112 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

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8.	 According to the sanitary operations performance standard, food-contact 

surfaces of equipment and utensils must be cleaned and sanitized: 

a.	 At a frequency that prevents the creation of insanitary conditions and the 

adulteration of product. 

b.	 Every four hours to prevent the creation of insanitary conditions and the 

adulteration of product. 

c.	 Daily to prevent the creation of insanitary conditions and the adulteration 

of product. 

d.	 Before operations begin and at midshift to prevent the creation of 

insanitary conditions and the adulteration of product.
 

9.	 Food-contact surfaces of equipment and utensils must be: 

a.	 Periodically cleaned and sanitized with 180° F water. 

b.	 Maintained in a sanitary condition using any effective cleaning and
 

sanitizing method.
 

c.	 Maintained in a sanitary condition using cleanup water that is at least 140° 

F and FSIS-approved disinfectants. 

10.Outer clothing (e.g., aprons, frocks, smocks, and garments) worn by 

employees who handle product must be: 

a.	 Changed every four hours to prevent insanitary conditions. 

b. Made of disposable materials or readily cleaned 

c.	 White in color so soilage can be easily detected. 

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Sanitation Performance Standards 

11-28-2016 

11. All persons working in contact with product, food-contact surfaces, and 

product packaging materials must: 

a.	 Wear disposable plastic or rubber gloves to prevent their hands from 

directly contaminating product. 

b.	 Wear cleanable caps or hats to prevent dislodged hair from falling into the 

product or ending up in product. 

c.	 Adhere to hygienic practices while on duty to prevent adulteration of 

product 

12. Which of the following statements is not listed in the regulations for 

employee hygiene? 

a.	 Employees working in contact with product must clean their hands and 

exposed forearms with a cleaning compound by vigorously rubbing the 

surfaces of their lathered hands and arms for at least 20 seconds. 

b.	 Clean garments must be worn at the start of each working day. 

c.	 Any person who has an open lesion such as a boil must be excluded from 

any operations that could result in product adulteration. 

d.	 Garments must be changed during the day as often as necessary to 

prevent adulteration. 

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Sanitation Performance Standards 

11-28-2016 

Fill-in the Blank Questions 

Refer to the module to fill in the blanks. 

1. A supply of running water that complies with 

at a suitable and under pressure as needed, must be 

provided in all areas where required. 

2.	 Water from any source not tested for potability or not certified as meeting the 

National Primary Drinking Water requirements is automatically considered to be 

a supply. 

3.	 Water, ice, and solutions used on products can be reused only for the 

purpose. 

4. Water, ice or solutions that have come into contact with raw product may not 

be reused on . 

5. The permitted use of the inedible receptacle or container must bear 

conspicuous and distinctive , to identify permitted uses (e.g., a 

system, or some other means. 

6. Depending upon the situation and the circumstances, the establishment must 

decide how to the product through all phases of the__________. 

7. has the authority to against any unhygienic 

practice that could result in insanitary conditions or adulterated 

product 

Inspection Methods	 11-115 
 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

SPS REGULATIONS WORKSHOP #4 

Match the noncompliance in the left column with the appropriate sanitation 

performance standard in the right column. The SPS can be used more than 

once. 

The establishment is applying a pesticide in a 

manner that is different than the documented 

uses. 

Odor coming from the condemned/inedible 

product rendering area is spreading to the 

slaughter floor. 

The establishment is reusing a brine solution to 

chill ready-to-eat products but has no 

documentation or other evidence that the reused 

brine is free of pathogens. 

A chute connecting an edible product 

department to an inedible product department 

does not have an access point or opening for 

sanitary inspection. 

There are round holes in several drop ceiling 

panels where pipes and electrical conduits have 

been removed. 

A commode in the men’s restroom is backed up 

and has overflowed onto the floor. 

An employee working with exposed product 

scratched his head with his fingers and did not 

clean them before continuing his work duties. 

A U.S. condemned barrel is leaking fluids from 

the bottom and there is an accumulation of 

poultry parts and whole birds on the floor. 

There is beaded condensation forming on the 

vent hood above the wiener casing peeler. 

A.	 Sanitary Operations 

B.	 Employee Hygiene 

C.	 Sewage Disposal 

D.	 Construction 

E.	 Grounds and Pest Control 

F.	 Plumbing 

G.	 Ventilation 

H.	 Dressing Rooms, 

Lavatories, and Toilets 

I.	 Equipment and Utensils 

J.	 Water Supply and Reuse 

K.	 Lighting 

Inspection Methods	 11-116 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sanitation Performance Standards 

11-28-2016 

SPS Documentation and Enforcement 

IPP must verify and document compliance and noncompliance with the SPS 

regulations. Noncompliance is the failure of an establishment to meet one or 

more regulatory requirements. Every time IPP find that the establishment is not 

meeting the SPS requirements, IPP are to document the noncompliance on an 

NR. IPP should not allow the establishment to address noncompliance without 

documenting it. If IPP determine that a SPS noncompliance is due to the 

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

document noncompliance with 9 CFR 416.1 in addition to the specific applicable 

SPS regulations. 

Enforcement for SPS Noncompliance Without the Finding of Direct 

Contamination or Adulteration of Product 

When IPP have determined that the establishment did not comply with a 

sanitation performance standard while performing the SPS task, and there is no 

direct contamination or adulteration of product, they next need to determine 

whether the noncompliance requires a regulatory control action to prevent 

subsequent contamination or adulteration of product. 

If the noncompliance does not need immediate attention, IPP are to notify the 

establishment management of the noncompliance and document the finding on 

an NR. 

If there is an imminent probability that the noncompliance will result in product 

contamination or adulteration if not addressed immediately, IPP will take a 

regulatory control action such as retaining product or rejecting the equipment or 

room with a tag in accordance with §416.6, notify the establishment as required 

by §500.2 and document the findings on an NR. 

§416.6 Tagging insanitary equipment, utensils, rooms or compartments 

When an FSIS program employee finds that any equipment, utensil, room, 

or compartment at an official establishment is insanitary or that its use could 

cause the adulteration of product, he will attach to it a “U.S. Rejected'' tag. 

Equipment, utensils, rooms, or compartments so tagged cannot be used until 

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

Rejected'' tag. 

Regulatory control actions should remain in effect until the establishment has 

brought itself back into compliance with regulations. 

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Sanitation Performance Standards 

11-28-2016 

Documentation and Enforcement for SPS Noncompliance AND the Finding 

of Direct Contamination or Adulteration of Product 

When IPP have determined that the establishment did not comply with a 

sanitation performance standard while performing the SPS task, and there is 

direct contamination or adulteration of product observed, all noncompliances are 

documented on one NR issued under a Sanitation SOP task. IPP are to record 

the results of the SPS task without a NR, indicate the regulations verified, and 

add a note in the Inspection Results Page, Findings Tab, Comment Box that a 

Sanitation SOP noncompliance was found and reference the Sanitation SOP NR. 

IPP will verify that the establishment implements corrective actions as part of the 

Sanitation SOP task. 

Example of SPS Noncompliance and SSOP Noncompliance Found While 

Performing the SPS Task 

At 10:08 a.m., while verifying whether the establishment’s pest management 

program was effective in preventing the harborage and breeding of pests on the 

grounds and within the establishment, I observed evidence of rodent activity in 

the food ingredient dry storage area which is noncompliance with 416.2(a). I 

found small pieces and shreds of paper and food granules on the floor under the 

storage rack that resulted from rodents gnawing through the ingredient bag. The 

ingredient bag was U.S. retained with tag #578690. I found 5 rodent droppings 

on top of the ingredient bag with the hole in it and 10 droppings along the west 

wall of the dry storage area. I also found a gnawed opening next to a pipe that 

enters at the base of the north wall, which is noncompliance with 416.2(b)(3). No 

evidence of rodent activity was found in adjacent production rooms. The dry 

storage area was U.S. rejected with tags #B578691 and #B578692. Ms. Jane 

Doe was notified of the insanitary condition of the food ingredient dry storage 

area and the direct contamination of a food ingredient and the subsequent 

regulatory controls. She was informed that the regulatory control actions would 

remain in effect until the establishment meets the requirements of 416.15. 

The SPS noncompliance with §416.2 (a) and 416.2(b)(3)) and the SSOP 

noncompliance with §416.13(c) would be documented on one NR under the 

Operational SSOP Review and Observation task. Under the SPS verification 

task, the CSI would identify the regulations verified and add information in the 

comment box that an SSOP noncompliance was found and reference the NR. 

When both SPS noncompliance(s) and HACCP noncompliance(s) involving 

direct product contamination with a food safety hazard are found while 

performing a SPS task, IPP are to document the SPS noncompliance(s) under a 

SPS verification task and the HACCP noncompliance(s) under the appropriate 

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Sanitation Performance Standards 

11-28-2016 

HACCP verification task. During the HACCP verification task, IPP will verify that 

the establishment implements corrective actions, including product control 

actions, that meet the requirements of 9 CFR 417.3(b). These corrective actions 

include a reassessment to determine whether the unforeseen hazard should be 

incorporated into the HACCP plan. Refer to the decision tree on the next page. 

Inspection Methods 11-119 
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Sanitation Performance Standards 

11-28-2016 

IPP Performs a SPS Task and Determines that Direct Product 

Contamination has Occurred
 

No Yes 

Is there a 

Food Safety 

Hazard? 

1. Schedule a SSOP R&O task 

2. Document SSOP NC 

3. Verify Corrective Action 

1. Schedule a HACCP verification task 

2. Document HACCP NC 

3. Verify Corrective Action 

Yes No Yes 

Under the SPS task, document: 

1. The SPS regulations that 

were verified 

2. That an SSOP or HACCP 

NC was observed and the 

NR# in the Findings tab 

Comment box 

Under the SPS task, 

document: 

1. The SPS regulations that 

were verified 

2. The SPS NC(s) 

Under the SSOP R&O task, 

document: 

1. All SPS regulations verified 

2. SPS NC(s) in the SSOP NR 

Under the SPS task, document: 

1. §416.1 verified (mandatory) 

so the task can be 

completed 

2. That an SSOP NC was 

observed and the NR# in 

the Findings tab Comment 

Is there 

a SPS 

NC Too? 

No 

Is there 

a SPS 

NC Too? 

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Sanitation Performance Standards 

11-28-2016 

U.S. Department of Agriculture 

FOOD SAFETY AND INSPECTION SERVICE 

NONCOMPLIANCE RECORD 

TYPE OF NONCOMPLIANCE 

 Food Safety  Other Consumer Protection 

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

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

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

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

8. INSPECTION TASK 9. VERIFICATION ACTIVITY 

 Review & Observation  Recordkeeping  Both 

9a. AFFECTED PRODUCT INFORMATION 

9b. RETAIN/REJECT TAGS 

10. DESCRIPTION OF NONCOMPLIANCE 

11. SIGNATURE OF INSPECTION PROGRAM EMPLOYEE 

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

12. PLANT MANAGEMENT RESPONSE: 

This document serves as written notification that your failure to comply with regulatory requirement(s) could result in 

additional regulatory or administrative action. 

13. SIGNATURE OF PLANT MANAGEMENT 14. DATE 

15. VERIFICATION SIGNATURE OF INSPECTION PROGRAM EMPLOYEE 16. DATE 

FSIS Form 5400-4 Distribution: Original & 1 copy to Establishment, 1 copy to Inspector 

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SPS Quick Reference to FSIS Directive 5000.1 Rev. 4
 Task What the IPP does Sections of the Directive that Apply Sections of the Directive 

when there is 

Noncompliance 

Sanitation 

Performance 

Standard 

(SPS) 

The IPP should 

select the SPS 

requirement or 

requirements that 

he/she is going to 

verify. These 

requirements are in 9 

CFR 416.2 – 416.5. 

Once the IPP has 

determined which 

requirements to 

verify, he/she will 

verify regulatory 

compliance with 

those requirements 

by following the 

instructions on the 

pages listed for each 

requirement. 

Grounds & Pest Control (416.2(a)), pages 10–12, Chapter II 

Construction (416.2(b)), pages 12–13, Chapter II 

Lighting (416.2(c)), pages 13-14, Chapter II 

Ventilation (416.2(d)), pages 14-15, Chapter II 

Plumbing and Sewage (416.2(e)), page 15, Chapter II 

Sewage Disposal (416.2(f)), pages 15-16, Chapter II 

Water Supply and Water, Ice, and Solution Reuse 

(416.2(g)), pages 16-19, Chapter II 

Dressing Rooms and Lavatories (416.2(h)), pages 19-21, 

Chapter II 

Equipment and Utensils (416.3(a)(b)(c)), pages 21-22, 

Chapter II 

Sanitary Operations (416.4(a)(b)(c)(d)), pages 22-23, 

Chapter II 

If the IPP finds that there is 

noncompliance with one or 

more of the regulations, IPP 

should refer to pages 58-65, 

Chapter V for instructions on 

the completion of a 

noncompliance record. 

If the IPP finds that, there is a 

trend of noncompliance 

occurring, IPP should refer to 

pages 66-67, Chapter V for 

instructions on NR association. 

If the IPP finds that an 

enforcement action should be 

recommended, IPP should 

refer to pages 68-74 of Chapter 

VI for instructions on the Rules 

of Practice. 

Employee Hygiene (416.5(a)(b)(c)), pages 23-25, Chapter II 

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TITLE 9--ANIMALS AND ANIMAL PRODUCTS 

CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 

AGRICULTURE 

PART 416--SANITATION--Table of Contents 

Sec. 416.1 General rules. 

Each official establishment must be operated and maintained in a manner sufficient to 

prevent the creation of insanitary conditions and to ensure that product is not 

adulterated. 

Sec. 416.2 Establishment grounds and facilities 

(a) Grounds and pest control. The grounds about an establishment must be maintained 

to prevent conditions that could lead to insanitary conditions, adulteration of product, or 

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

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

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

safe and effective under the conditions of use and not be applied or stored in a manner 

that will result in the adulteration of product or the creation of insanitary conditions. 

(b) Construction. 

(1) Establishment buildings, including their structures, rooms, and compartments 

must be of sound construction, be kept in good repair, and be of sufficient size to 

allow for processing, handling, and storage of product in a manner that does not 

result in product adulteration or the creation of insanitary conditions. 

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

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

prevent adulteration of product or the creation of insanitary conditions. 

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

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

and mice. 

(4) Rooms or compartments in which edible product is processed, handled, or stored 

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

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

adulteration and the creation of insanitary conditions. 

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(c) Light. 

Lighting of good quality and sufficient intensity to ensure that sanitary conditions are 

maintained and that product is not adulterated must be provided in areas where food is 

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

and in hand-washing areas, dressing and locker rooms, and toilets. 

(d) Ventilation. 

Ventilation adequate to control odors, vapors, and condensation to the extent necessary 

to prevent adulteration of product and the creation of insanitary conditions must be 

provided. 

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

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

establishment; 

(2) Properly convey sewage and liquid disposable waste from the establishment; 

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

prevent the creation of insanitary conditions throughout the establishments 

(4) Provide adequate floor drainage in all areas where floors are subject to floodingtype cleaning or where normal operations release or discharge water or other liquid 

waste on the floor; 

(5) Prevent back-flow conditions in and cross-connection between piping systems 

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

product manufacturing; and 

(6) Prevent the backup of sewer gases. 

(f) Sewage disposal. Sewage must be disposed into a sewage system separate from all 

other drainage lines or disposed of through other means sufficient to prevent backup of 

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

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

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

authority upon request. 

(g) Water supply and water, ice, and solution reuse. 

(1) A supply of running water that complies with the National Primary Drinking Water 

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

Inspection Methods 11-124 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

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

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

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

the State or local health agency, certifying or attesting to the potability of the water 

supply. If an establishment uses a private well for its water supply, it must make 

available to FSIS, upon request, documentation certifying the potability of the water 

supply that has been renewed at least semi-annually. 

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

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

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

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

reduced to prevent adulteration of product. 

(3) Water, ice, and solutions used to chill or wash raw product may be reused for the 

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

microbiological contamination so as to prevent contamination or adulteration of 

product. Reuse that which has come into contact with raw product may not be used 

on ready-to-eat product. 

(4) Reconditioned water that has never contained human waste and that has been 

treated by an onsite advanced wastewater treatment facility may be used on raw 

product, except in product formulation, and throughout the facility in edible and 

inedible production areas, provided that measures are taken to ensure that this 

water meets the criteria prescribed in paragraph (g)(1) of this section. Product, 

facilities, equipment, and utensils coming in contact with this water must undergo a 

separate final rinse with non-reconditioned water that meets the criteria prescribed in 

paragraph (g)(1) of this section. 

(5) Any water that has never contained human waste and that is free of pathogenic 

organisms may be used in edible and inedible product areas, provided it does not 

contact edible product. For example, such reuse water may be used to move heavy 

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

areas, livestock pens, trucks, poultry cages, picker aprons, picking room floors, and 

similar areas within the establishment. 

(6) Water that does not meet the use conditions of paragraphs (g)(1) through (g)(5) 

of this section may not be used in areas where edible product is handled or prepared 

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

conditions. 

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(h) Dressing rooms, lavatories, and toilets. 

(1) Dressing rooms, toilet rooms, and urinals must be sufficient in number, ample in 

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

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

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

stored, or handled. 

(2) Lavatories with running hot and cold water, soap, and towels, must be placed in 

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

necessary to ensure cleanliness of all persons handling any product. 

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

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

Sec. 416.3 Equipment and utensils. 

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

ingredients must be of such material and construction to facilitate thorough cleaning and 

to ensure that their use will not cause the adulteration of product during processing, 

handling, or storage. Equipment and utensils must be maintained in sanitary condition 

so as not to adulterate product. 

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

that prevents FSIS inspection program employees from inspecting the equipment or 

utensils to determine whether they are in sanitary condition. 

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

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

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

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

uses. 

Sec. 416.4 Sanitary operations. 

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

must be cleaned and sanitized as frequently as necessary to prevent the creation of 

insanitary conditions and the adulteration of product. 

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

of the establishment must be cleaned and sanitized as frequently as necessary to 

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

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

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

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

product or create insanitary conditions. Documentation substantiating the safety of a 

chemical's use in a food processing environment must be available to FSIS inspection 

program employees for review. 

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

loading, and unloading at and during transportation from official establishments. 

Sec. 416.5 Employee hygiene. 

(a) Cleanliness. All persons working in contact with product, food-contact surfaces, and 

product-packaging materials must adhere to hygienic practices while on duty to prevent 

adulteration of product and the creation of insanitary conditions. 

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

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

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

as often as necessary to prevent adulteration of product and the creation of insanitary 

conditions. 

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

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

microbial contamination, must be excluded from any operations which could result in 

product adulteration and the creation of insanitary conditions until the condition is 

corrected. 

Sec. 416.6 Tagging insanitary equipment, utensils, rooms or compartments. 

When an FSIS program employee finds that any equipment, utensil, room, or 

compartment at an official establishment is insanitary or that its use could cause the 

adulteration of product, he will attach to it a “U.S.Rejected'' tag. Equipment, utensils, 

rooms, or compartments so tagged cannot be used until made acceptable. Only an 

FSIS program employee may remove a ``U.S. Rejected'' tag. 

Inspection Methods 11-127