21 CFR 110.20: Plant and grounds
Requires food plant operators to maintain grounds and design, construct, and light buildings so they prevent pests and contamination, and permit sanitary operations, cleaning, adequate space, and separation of contamination-prone operations.
Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food · Subpart B, Buildings and Facilities
How FDA words it
The opening lines investigators use most when they cite 110.20, from the 483s we hold.
Failure to provide adequate screening or other protection against pests.Most used
Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food-packaging materials.110.20(b)
Failure to provide safety-type lighting fixtures suspended over exposed food.110.20(b)
Recent 483s citing 110.20
- Chamberlain Farms Inc. · Owensville, IndianaOn 08/14/2012, while cantaloupes were being processed, I observed, standing water… Aug 14, 2020
- Topway Enterprises · Houston, TexasThe plant is not constmcted in such a manner as to allow floors to be adequately… Feb 8, 2019
- Vulto Creamery LLC · Walton, New YorkThe plant is not constructed in such a manner as to prevent drip and condensate… Mar 22, 2017
- The Aloe Source · Plano, TexasProper precautions to protect food and food-contact surfaces from contamination… May 20, 2016
- Blue Bell Creameries, L.P. · Brenham, TexasThe plant is not constructed in such a manner as to prevent condensate from… May 1, 2015
The regulation text
§ 110.20 Plant and grounds.
(a)Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to:
(1)Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.
(2)Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.
(3)Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.
(4)Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed.
If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.
(b)Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall:
(1)Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.
(2)Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or 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, air flow, enclosed systems, or other effective means.
(3)Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including:
(i)Using protective coverings.
(ii)Controlling areas over and around the vessels to eliminate harborages for pests.
(iii)Checking on a regular basis for pests and pest infestation.
(iv)Skimming the fermentation vessels, as necessary.
(4)Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.
(5)Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.
(6)Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.
(7)Provide, where necessary, adequate screening or other protection against pests.
Questions
What does 21 CFR 110.20 require?
Requires food plant operators to maintain grounds and design, construct, and light buildings so they prevent pests and contamination, and permit sanitary operations, cleaning, adequate space, and separation of contamination-prone operations.
How do FDA investigators word a 110.20 observation?
The most common opening is: “Failure to provide adequate screening or other protection against pests.”
Which sections are cited alongside 110.20?
In the same 483s, investigators most often also cite 110.35 (Sanitary operations), 110.80 (Processes and controls), 110.10 (Personnel), 110.40 (Equipment and utensils).