As used in this part:

1. (1) “Breast milk donor” means a lactating woman who voluntarily contributes milk to a human breast milk bank;

2. (2) “Breast milk processing centers” means for-profit entities that:

   1. (A) Collect human breast milk; and
   2. (B) Produce human breast milk-based products;
3. (3) “Breast milk sharing” means the practice of one (1) mother giving her breast milk to another person without payment;

4. (4)

   1. (A) “Clean” means to physically remove dirt and debris by using detergents and water.
   2. (B) An example of an appropriate detergent is common kitchen dish detergent;
5. (5) “Collection” means the act of obtaining donor human breast milk;

6. (6)

   1. (A) “Disinfect” means to destroy or inactivate most microorganisms on hard surfaces.

   2. (B)

      1. (i) Disinfection requires specific times of exposure to agents.
      2. (ii) Follow manufacturer's instructions;
7. (7) “Distribution” means the delivery of pasteurized donor human breast milk (PDHBM) from a human breast milk bank to a hospital or other entities appropriate to receive breast milk, e.g., researchers, family with a prescription;

8. (8)

   1. (A) “Donor human breast milk” means milk:

      1. (i) Expressed and donated by lactating women;
      2. (ii) Subjected to a validated pathogen inactivation method; and
      3. (iii) Dispensed for use by a recipient who is not the donor's own baby.
   2. (B) Human breast milk banks may use the following additional terms.

   3. (C) If terms are used, they comply with the following definitions:

      1. (i) “Dairy-restricted” means breast milk expressed by mothers who report avoidance of explicit and inexplicit dairy products, including all processed foods;
      2. (ii) “Early-term breast milk” means breast milk that is collected from term mothers (greater than thirty-seven (37) weeks’ gestation) during the first month of lactation;
      3. (iii) “Fresh-frozen breast milk” means fresh-raw human breast milk that has been frozen at negative eighteen degrees Celsius (-18°C) for not longer than twelve (12) months from date of collection;

      4. (iv) “Fresh-raw breast milk” means human breast milk:

         1. (a) (a) Expressed within seventy-two (72) hours; and
         2. (b) (b) Stored at or below four degrees Celsius (4°C);
      5. (v) “Holder pasteurized breast milk” means fresh-raw and/or fresh-frozen breast milk that has been subjected to a validated method of pathogen reduction;
      6. (vi) “Pasteurized donor human breast milk (PDHBM)” means donor human breast milk that has been collected, processed, and dispensed according to this part;
      7. (vii) “Pooled breast milk” means human breast milk combined with deposits from more than one (1) donor;
      8. (viii) “Preterm breast milk” means human breast milk expressed within the first four (4) weeks postpartum by a mother who delivered at or before thirty-six (36) weeks’ gestation;
      9. (ix) “Reduced-fat breast milk” means breast milk that is separated and de-fatted for chylothorax patients or other patients requiring low-fat milk (less than one gram per deciliter (1g/dl) fat content); and

      10. (x) “Term breast milk” means human breast milk pumped by mothers giving birth:

          1. (a) (a) After thirty-six (36) weeks; or
          2. (b) (b) Before thirty-six (36) weeks but after four (4) weeks postpartum;
9. (9) “Donor human breast milk bank” means a service established for the purpose of recruiting and collecting breast milk from donors and processing, screening, storing, and distributing donated breast milk in accordance with this part to meet the specific needs of individuals;

10. (10)

    1. (A) “Donor human breast milk contact surfaces” means all surfaces that contact donor human breast milk during the normal course of operations.

    2. (B) This includes utensils and food­contact surfaces of equipment such as:

       1. (i) Flasks;
       2. (ii) Bottles; and
       3. (iii) Caps;

11. (11)

    1. (A) “Donor human breast milk depot” means an agency affiliated with a donor human breast milk bank that collects and stores donor breast milk that is then transported to the affiliated breast milk bank for processing.
    2. (B) The breast milk bank accepts responsibility for all screening, processing, and distributing of milk;
12. (12) “Donor human breast milk distribution site” means an agency affiliated with a breast milk bank that stores and distributes donor breast milk that was processed by a breast milk bank, and distributes the breast milk to hospitals or outpatients according to this part;
13. (13) “Equipment, clean” means equipment that is cleaned and maintained according to manufacturer's instructions and to applicable local and federal rules, laws, and regulations for commercial food preparation;
14. (14) “Processing” means the use of evidence-based methodologies, including pasteurization, to prepare safe breast milk for recipients;

15. (15) “Processing fees” means fees assessed by the donor breast milk bank to offset the cost of:

    1. (A) Donor screening;
    2. (B) Breast milk processing;
    3. (C) Storing;
    4. (D) Distribution; and
    5. (E) Recordkeeping;
16. (16) “Product recall” means the formal process of recalling all dispensed breast milk within a batch or batches that are suspected may potentially cause harm;
17. (17) “Product replacement” means the process of dispensing additional breast milk to a recipient or recipients after the initial dispensed breast milk has been identified as unacceptable, but not unsafe;
18. (18) “Quality control operation” means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of Title 21 of the Code of Federal Regulations, reserved for rules of the Food and Drug Administration;

19. (19)

    1. (A) “Sanitize” means to reduce microbial load to increase safety and decrease risk of contamination without adversely affecting the product or its safety for the consumer.
    2. (B) An example of a sanitizing agent is seventy percent (70%) or higher isopropyl alcohol; and
20. (20) “Sterilize” means to destroy all microorganisms, including spores, via autoclave or other method or methods of sterilization.