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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR112]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
 
PART 112STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
 

Subpart L - Equipment, Tools, Buildings, and Sanitation

Sec. 112.121 What equipment and tools are subject to the requirements of this subpart?

Equipment and tools subject to the requirements of this subpart are those that are intended to, or likely to, contact covered produce; and those instruments or controls used to measure, regulate, or record conditions to control or prevent the growth of microorganisms of public health significance. Examples include knives, implements, mechanical harvesters, waxing machinery, cooling equipment (including hydrocoolers), grading belts, sizing equipment, palletizing equipment, and equipment used to store or convey harvested covered produce (such as containers, bins, food-packing material, dump tanks, flumes, and vehicles or other equipment used for transport that are intended to, or likely to, contact covered produce).

Sec. 112.122 What buildings are subject to the requirements of this subpart?

Buildings subject to the requirements of this subpart include:

(a) Any fully- or partially-enclosed building used for covered activities, including minimal structures that have a roof but do not have any walls; and

(b) Storage sheds, buildings, or other structures used to store food contact surfaces (such as harvest containers and food-packing materials).

Sec. 112.123 What general requirements apply regarding equipment and tools subject to this subpart?

All of the following requirements apply regarding equipment and tools subject to this subpart:

(a) You must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained; and

(b) Equipment and tools must be:

(1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent spaces; and

(2) Stored and maintained to protect covered produce from being contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools from attracting and harboring pests.

(c) Seams on food contact surfaces of equipment and tools that you use must be either smoothly bonded, or maintained to minimize accumulation of dirt, filth, food particles, and organic material and thus minimize the opportunity for harborage or growth of microorganisms.

(d)(1) You must inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce.

(2) You must maintain and clean all non-food-contact surfaces of equipment and tools subject to this subpart used during harvesting, packing, and holding as frequently as reasonably necessary to protect against contamination of covered produce.

(e) If you use equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, contact covered produce, you must do so in a manner that minimizes the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards.

Sec. 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?

Instruments or controls you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or other conditions, in order to control or prevent the growth of microorganisms of public health significance, must be:

(a) Accurate and precise as necessary and appropriate in keeping with their purpose;

(b) Adequately maintained; and

(c) Adequate in number for their designated uses.

Sec. 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?

Equipment that is subject to this subpart that you use to transport covered produce must be:

(a) Adequately clean before use in transporting covered produce; and

(b) Adequate for use in transporting covered produce.

Sec. 112.126 What requirements apply to my buildings?

(a) All of the following requirements apply regarding buildings:

(1) Buildings must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for covered activities to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards. Buildings must:

(i) Provide sufficient space for placement of equipment and storage of materials;

(ii) Permit proper precautions to be taken to reduce the potential for contamination of covered produce, food contact surfaces, or packing materials with known or reasonably foreseeable hazards. The potential for contamination must be reduced by effective design including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, enclosed systems, or other effective means; and

(2) You must provide adequate drainage in all areas where normal operations release or discharge water or other liquid waste on the ground or floor of the building.

(b) You must implement measures to prevent contamination of your covered produce and food contact surfaces in your buildings, as appropriate, considering the potential for such contamination through:

(1) Floors, walls, ceilings, fixtures, ducts, or pipes; and

(2) Drip or condensate.

Sec. 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?

(a) You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by:

(1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or

(2) Separating domesticated animals in a fully enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition.

(b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials.

Sec. 112.128 What requirements apply regarding pest control in buildings?

(a) You must take those measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate.

(b) For fully-enclosed buildings, you must take measures to exclude pests from your buildings.

(c) For partially-enclosed buildings, you must take measures to prevent pests from becoming established in your buildings (such as by use of screens or by monitoring for the presence of pests and removing them when present).

Sec. 112.129 What requirements apply to toilet facilities?

All of the following requirements apply to toilet facilities:

(a) You must provide personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities.

(b) Your toilet facilities must be designed, located, and maintained to:

(1) Prevent contamination of covered produce, food contact surfaces, areas used for a covered activity, water sources, and water distribution systems with human waste;

(2) Be directly accessible for servicing, be serviced and cleaned at a frequency sufficient to ensure suitability of use, and be kept supplied with toilet paper; and

(3) Provide for the sanitary disposal of waste and toilet paper.

(c) During growing activities that take place in a fully-enclosed building, and during covered harvesting, packing, or holding activities, you must provide a hand-washing station in sufficiently close proximity to toilet facilities to make it practical for persons who use the toilet facility to wash their hands.

Sec. 112.130 What requirements apply for hand-washing facilities?

All of the following requirements apply to hand-washing facilities:

(a) You must provide personnel with adequate, readily accessible hand-washing facilities during growing activities that take place in a fully-enclosed building, and during covered harvest, packing, or holding activities.

(b) Your hand-washing facilities must be furnished with:

(1) Soap (or other effective surfactant);

(2) Running water that satisfies the requirements of § 112.44(a) for water used to wash hands; and

(3) Adequate drying devices (such as single service towels, sanitary towel service, or electric hand dryers).

(c) You must provide for appropriate disposal of waste (for example, waste water and used single-service towels) associated with a hand-washing facility and take appropriate measures to prevent waste water from a hand-washing facility from contaminating covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards.

(d) You may not use antiseptic hand rubs as a substitute for soap (or other effective surfactant) and water.

Sec. 112.131 What must I do to control and dispose of sewage?

All of the following requirements apply for the control and disposal of sewage:

(a) You must dispose of sewage into an adequate sewage or septic system or through other adequate means.

(b) You must maintain sewage and septic systems in a manner that prevents contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards.

(c) You must manage and dispose of leakages or spills of human waste in a manner that prevents contamination of covered produce, and prevents or minimizes contamination of food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems.

(d) After a significant event (such as flooding or an earthquake) that could negatively impact a sewage or septic system, you must take appropriate steps to ensure that sewage and septic systems continue to operate in a manner that does not contaminate covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems.

Sec. 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?

All of the following requirements apply to the control and disposal of trash, litter, and waste in areas used for covered activities:

(a) You must convey, store, and dispose of trash, litter and waste to:

(1) Minimize the potential for trash, litter, or waste to attract or harbor pests; and

(2) Protect against contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards.

(b) You must adequately operate systems for waste treatment and disposal so that they do not constitute a potential source of contamination in areas used for a covered activity.

Sec. 112.133 What requirements apply to plumbing?

The plumbing must be of an adequate size and design and be adequately installed and maintained to:

(a) Distribute water under pressure as needed, in sufficient quantities, in all areas where used for covered activities, for sanitary operations, or for hand-washing and toilet facilities;

(b) Properly convey sewage and liquid disposable waste;

(c) Avoid being a source of contamination to covered produce, food contact surfaces, areas used for a covered activity, or agricultural water sources; and

(d) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for a covered activity, for sanitary operations, or for use in hand-washing facilities.

Sec. 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?

(a) If you have domesticated animals, to prevent contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems with animal waste, you must:

(1) Adequately control their excreta and litter; and

(2) Maintain a system for control of animal excreta and litter.

(b) [Reserved]

Sec. 112.140 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part.

(b) You must establish and keep documentation of the date and method of cleaning and sanitizing of equipment subject to this subpart used in:

(1) Growing operations for sprouts; and

(2) Covered harvesting, packing, or holding activities.

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

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