21 CFR 110.10: Personnel
Requires plant management to exclude ill or infected workers from contamination-risk tasks, enforce hygienic practices, and ensure personnel are trained and competent, with designated supervisors responsible for compliance.
Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food · Subpart A, General Provisions
How FDA words it
The opening lines investigators use most when they cite 110.10, from the 483s we hold.
Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.Most used
Appropriate training in food handling techniques and food protection principles has not been provided to food handlers and supervisors.110.10(c)
Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms.110.10(b)
Recent 483s citing 110.10
- Vulto Creamery LLC · Walton, New YorkFailure to take necessary precautions to protect against contamination of food and… Mar 22, 2017
- Blue Bell Creameries, L.P. · Brenham, TexasFailure to wear beard covers in an effective manner… May 1, 2015
- Jeni's Splendid Ice Creams, LLC · Columbus, OhioResponsibility for assuring compliance with current good manufacturing practices… Apr 30, 2015
- Blue Bell Creameries Inc, · Sylacauga, AlabamaSuitable outer garments are not worn that protect against contamination of food and… Apr 30, 2015
- Blue Bell Creameries, LP · Broken Arrow, OklahomaEmployees did not wash and sanitize hands thoroughly in an adequate hand-washing… Apr 23, 2015
The regulation text
§ 110.10 Personnel.
The plant management shall take all reasonable measures and precautions to ensure the following:
(a)Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
(b)Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:
(1)Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials.
(2)Maintaining adequate personal cleanliness.
(3)Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.
(4)Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.
(5)Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.
(6)Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.
(7)Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.
(8)Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.
(9)Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.
(c)Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.
(d)Supervision. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel.
[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
Questions
What does 21 CFR 110.10 require?
Requires plant management to exclude ill or infected workers from contamination-risk tasks, enforce hygienic practices, and ensure personnel are trained and competent, with designated supervisors responsible for compliance.
How do FDA investigators word a 110.10 observation?
The most common opening is: “Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.”
Which sections are cited alongside 110.10?
In the same 483s, investigators most often also cite 110.80 (Processes and controls), 110.20 (Plant and grounds), 110.35 (Sanitary operations), 110.40 (Equipment and utensils).