07 Sanitation Performance Standards (SPS)

9 CFR 416.1 - 416.6 

Purpose: 

Proper and effective sanitation is vital to every step of the food manufacturing (making) 

process. This section will focus on helping the IPP develop a working knowledge of the 

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

learn howto perform the Sanitation Performance Standards Verification task using the “GAD” 

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

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

understand theirregulatory responsibilities under 9 CFR 416.6. 

Facilities that must comply with the SPS regulations: 

• Federal and State inspected meat and poultry establishments 

• Import/Export facilities 

• Identification (ID) warehouses 

• Custom-exempt operations 

Sanitation Requirements: 

• CFR 416.1 - 416.5 

• FSIS Directive 5000.1, Revision 5 addresses the Sanitation Performance Standards 

(SPS)regulations and the SPS Verification task 

Purpose of the SPS Verification task: 

To verify compliance with the Sanitation Performance Standards (9 CFR 416.1 - 416.5), IPP will 

inspect conditions in and around the official premises of the establishment, review documents, 

and inspect the facility and equipment for overall sanitary conditions. The establishment 

designates the official premises during the grant of application process. IPP must conduct all 

inspection activities within the physical boundaries designated as the official premises of the 

establishment. 

When performing the SPS task to verify SPS requirements:

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

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

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

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

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

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

chemicals that are in the establishment. 

When performing the task, IPP should: 

 Have a working knowledge of specific SPS regulations; 

 Ask questions specific to the regulations; 

 Directly observe areas relevant to the regulations; and 

 Assess the establishment’s answers to those questions. 

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How to determine compliance or noncompliance?

Use professional knowledge and good judgement 

 Gather information 

 Assess each situation 

 Determine if an insanitary condition has occurred. 

416.1 General Rules 

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

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

product. 

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

fails to maintain sanitary conditions and that product adulteration may occur as a result. 

What does “insanitary” mean? 

“A state, condition, or occurrence which may lead to the contamination or adulteration of edible 

meat or poultry product when it is exposed, processed, handled, stored, or packaged”. 

Sanitation Performance Standards: 

FSIS Directive 5000.1, Rev. 5 - Verifying an Establishment’s Food Safety System 

SPS Regulations: 9 CFR Part 416.2 - 416.5: 

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

prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with 

inspection by FSIS program employees. Establishments must have in place a pest management 

program to prevent the harborage and breeding of pests on the grounds and within establishment 

facilities. Pest control substances used must be safe and effective under the conditions of use and 

not be applied or stored in a manner that will result in the adulteration of product or the creation of 

insanitary conditions. 

416.2(b) Construction416.2(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. 

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

to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation 

of insanitary conditions. 

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

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

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

separate and distinct from rooms or compartments in which inedible product is processed, handled, or 

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

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

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

processed, handled, stored, or examined; where equipment and utensils are cleaned; and in handwashing areas, dressing and locker rooms, and toilets. 

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

necessary to prevent adulteration of product and the creation of insanitary conditions must be provided. 

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

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

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

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

creation of insanitary conditions throughout the establishment. 

416.2(e)(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning 

or where normal operations release or discharge water or other liquid waste on the floor. 

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

wastewater or sewage and piping systems that carry water for product manufacturing. 

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

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

other drainage lines or disposed of through other means sufficient to prevent backup of sewage into 

areas where product is processed, handled, or stored. When the sewage disposal system is a private 

system requiring approval by a State or local health authority, the establishment must furnish FSIS with 

the letter of approval from that authority upon request. 

Note: Sewage is "refuse liquids or waste matter usually carried off by sewers" (from the online 

Merriam-Webster dictionary). 

416.2(g) Water supply, water, ice, solution reuse416.2(g)(1) A supply of running water that complies with the National Primary Drinking Water 

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

provided in all areas where required (for processing product, for cleaning rooms and equipment, utensils, 

and packaging materials, for employee sanitary facilities, etc.). If an establishment uses a municipal 

water supply, it must make available to FSIS, upon request, a water report, issued under the authority of 

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

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

documentation certifying the potability of the water supply that has been renewed at least semi-annually. 

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

cook ready-to-eat product may be reused for the same purpose, provided that they are maintained free 

of pathogenic organisms and fecal coliform organisms and that other physical, chemical, and 

microbiological contamination have been reduced to prevent adulteration of product. 

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

purpose provided that measures are taken to reduce physical, chemical, and microbiological 

contamination so as to prevent contamination or adulteration of product. Reuse that has come into 

contact with raw product may not be used on ready-to-eat product. 416.2(g)(4) Reconditioned water that 

has never contained human waste and that has been treated by an onsite advanced wastewater 

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

edible and inedible production areas, provided that measures are taken to ensure that this water meets 

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the criteria prescribed in paragraph (g)(1) of this section. Product, facilities, equipment, and utensils 

coming in contact with this water must undergo a separate final rinse with non-reconditioned water that 

meets the criteria prescribed in paragraph (g)(1) of this section. 

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

organisms may be used in edible and inedible product areas, provided it does not contact edible product. 

For example, such reuse water may be used to move heavy solids, to flush the bottom of open 

evisceration troughs, or to wash antemortem areas, livestock pens, trucks, poultry cages, picker aprons, 

picking room floors, and similar areas within the establishment. 

416.2(g)(6) Water that does not meet the use conditions of paragraphs (g)(1) through (g)(5) of this 

section may not be used in areas where edible product is handled or prepared or in any manner that 

would allow it to adulterate edible product or create insanitary conditions. 

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

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

conveniently located, and maintained in a sanitary condition and in good repair at all times to ensure 

cleanliness of all persons handling any product. They must be separate from the rooms and 

compartments in which products are processed, stored, or handled. 

416.2(h)(2) Lavatories with running hot and cold water, soap, and towels must be placed in or near 

toilet and urinal rooms and at such other places in the establishment as necessary to ensure cleanliness 

of all persons handling any product. 

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

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

416.3 Equipment & Utensils416.3(a) Equipment and utensils used for processing or otherwise handling edible product or ingredients 

must be of such material and construction to facilitate thorough cleaning and to ensure that their use will 

not cause the adulteration of product during processing, handling, or storage. Equipment and utensils 

must be maintained in sanitary condition so as not to adulterate product. 

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

prevents FSIS program employees from inspecting the equipment or utensils to determine whether they 

are in sanitary condition. 

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

their use will not result in the adulteration of any edible product or in the creation of insanitary conditions. 

Such receptacles must not be used for storing any edible product and must bear conspicuous and 

distinctive marking to identify permitted uses. 

416.4 Sanitary Operations: 

416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be 

cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the 

adulteration of product. 

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

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

establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of 

insanitary conditions and the adulteration of product. 

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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 beavailable 

to FSIS inspection program employees for review. 

416.4(d) Product must be protected from adulteration during processing, handling, storage, loading, and 

unloading at and during transportation from official establishments. 

416.5 Employee Hygiene: 

416.5(a) Cleanliness. All persons working in contact with product, food-contact surfaces, and productpackaging materials must adhere to hygienic practices while on duty to prevent adulteration of productand 

the creation of insanitary conditions. 

416.5(b) Clothing. Aprons, frocks, and other outer clothing worn by persons who handle product must be of 

material that is disposable or readily cleaned. Clean garments must be worn at the start of each working 

day and garments must be changed during the day as often as necessary to prevent adulterationof product 

and the creation of insanitary conditions. 

416.5(c) Disease control. Any person who has or appears to have an infectious disease, open lesion, 

including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, mustbe 

excluded from any operations which could result in product adulteration and the creation of insanitary 

conditions until the condition is corrected. 

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

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. 

Compliance / Noncompliance 

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

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

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

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

establishment’s repeated failure to maintain sanitary conditions, the IPP should consult with their 

FLS or IIC to determine if 416.1 should be added to the noncompliance record. 

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

is insanitary or that its use could cause the adulteration of product, he or she will attach to it a 

“U.S. Rejected'' tag. Equipment, utensils, rooms, or compartments tagged cannot be used until 

made acceptable. Only an FSIS program employee may remove a “U.S. Rejected''tag. 

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