(b) The methods for maintaining cleanliness include but are not limited to:

1. (1)

   1. (A) Wearing outer garments suitable to the operation in a manner that protects against the contamination of:

(i) Breast milk;

1. (ii) Breast milk contact surfaces; or

   1. (iii) Breast milk packaging materials.
   2. (B) Wearing a gown, apron, or lab coat that covers clothing;
2. (2) Maintaining adequate personal cleanliness;

3. (3)

   1. (A) Washing and sanitizing hands and arms from elbows downward thoroughly before starting work, whenever:

      1. (i) Work area is left; and
      2. (ii) They become soiled or contaminated.
   2. (B) Immediately dry hands and arms with an individual single­use-only towel.
   3. (C) Put on disposable gloves after washing hands;

4. (4)

   1. (A) Not washing hands in sinks used for milk preparation or washing equipment.
   2. (B) Keeping hand washing facilities in a clean condition and in good repair;

5. (5)

   1. (A) Removing all unsecured jewelry or other objects that might fall into:

      1. (i) Breast milk;
      2. (ii) Equipment; or
      3. (iii) Containers.
   2. (B) Rings may be left on fingers and covered by gloves after hands are washed;

6. (6)

   1. (A)

      1. (i) Covering hair with:

(b) (b) Caps; or

1. (c) (c) Other effective hair restraints.

   1. (ii) Include beard covers when appropriate.
   2. (B) Dangling earrings must be tucked under hair net;

2. (7) No eating food, chewing gum, drinking beverages, or using tobacco in areas where:

   1. (A) Breast milk may be exposed; or
   2. (B) Equipment or utensils are washed;
3. (8) Excluding everyone with an illness, e.g., vomiting, diarrhea, jaundice, sore throat with fever, and open lesion, or other abnormal source of microbial contamination, from the breast milk processing and breast milk handling areas;
4. (9) Reporting potential exclusion to a breast milk bank staff member designated to decide appropriateness of potential exclusion;
5. (10) Preparing breast milk in a dedicated clean space with facilities for aseptic technique;

6. (11) Cleaning and sanitizing breast milk contact surfaces and work areas by a process that is effective in destroying microorganisms of public health significance:

   1. (A) Before handling or processing milk; and
   2. (B) After any interruption in processing that may lead to contamination;
7. (12) Making clean sinks and sanitizing dispensers available in the breast milk handling area;
8. (13) Ensuring that personnel responsible for identifying sanitation failures or breast milk contamination have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe breast milk;

9. (14) Ensuring that breast milk handlers and supervisors:

   1. (A) Receive appropriate training in proper food-handling techniques and food-production principles; and
   2. (B) Are informed of the dangers of poor personal hygiene and unsanitary practices;
10. (15) Ensuring that competent supervisory personnel take responsibility for ensuring compliance by all lab personnel; and
11. (16) Cleaning all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food.