2.1 Clean--Physically remove dirt and debris by using detergents and water. An example of an appropriate detergent is common kitchen dish detergent.

2.2 Collection--The act of obtaining donor human milk.

2.3 Disinfect--Destroy or inactivate most microorganisms on hard surfaces. Disinfection requires specific times of exposure to agents; follow manufacturer's instructions.

2.4 Distribution--The delivery of pasteurized donor human milk (PDHM) from a human milk bank to a hospital or other entities appropriate to receive milk (e.g., researchers, family with a prescription).

2.5 Donor Human Milk Bank--A donor human milk bank is a service established for the purpose of recruiting and collecting milk from donors, and processing, screening, storing and distributing donated milk, in accordance with these rules, to meet the specific needs of individuals.

2.6 Donor Human Milk--Donor human milk is milk expressed and donated by lactating women, subjected to a validated pathogen inactivation method, and dispensed for use by a recipient who is not the donor's own baby. Milk banks may use the following additional terms; if terms are used, they comply with the following definitions:

2.6.1 Fresh-raw milk -- Human milk expressed within 72 hours and stored at or below 4°C.

2.6.2 Fresh-frozen milk -- Fresh raw human milk that has been frozen at -18°C for not longer than 12 months from date of collection.

2.6.3 Pasteurized milk -- Fresh-raw and/or fresh-frozen milk that has been subjected to a validated method of pathogen reduction.

2.6.4 Pooled milk -- Human milk combined with deposits from more than one donor.

2.6.5 Preterm milk -- Human milk expressed within the first 4 weeks postpartum by a mother who delivered at or before 36 weeks gestation.

2.6.6 Term milk -- Human milk pumped by mothers giving birth after 36 weeks, or before 36 weeks but after 4 weeks postpartum.

2.6.7 Reduced fat milk -- Milk that is separated and de-fatted for chylothorax patients or other patients requiring low fat milk (<1g/dl fat content).

2.6.8 Early term milk -- Milk that is collected from term mothers (>37 weeks gestation) during the first month of lactation.

2.6.9 Dairy restricted -- Milk expressed by mothers who report avoidance of explicit and inexplicit dairy products (including all processed foods).

2.6.10 Pasteurized donor human milk (PDHM) -- Donor human milk that has been collected, processed, and dispensed according to these rules.

2.7 Donor Human Milk-Contact Surfaces--All surfaces that contact donor human milk during the normal course of operations. This includes utensils and food-contact surfaces of equipment, such as flasks, bottles, and caps.

2.8 Donor Human Milk Depot--A donor human milk depot is an agency affiliated with a donor human milk bank that collects and stores donor milk that is then transported to the affiliated milk bank for processing. The milk bank accepts responsibility for all screening, processing and distributing of milk.

2.9 Donor Human Milk Distribution Site--A donor human milk distribution site is an agency affiliated with a milk bank that stores and distributes donor milk that was processed by a milk bank, and distributes the milk to hospitals or outpatients according to these rules.

2.10 Equipment, Clean--Equipment that is cleaned and maintained according to manufacturer's instructions and to applicable local and federal regulations for commercial food preparation.

2.11 Milk Donor--A lactating woman who voluntarily contributes milk to a human milk bank.

2.12 Milk-Processing Centers--For-profit entities that collect human milk and produce human milk-based products.

2.13 Milk Sharing--The practice of one mother giving her milk to another person without payment.

2.14 Processing--The use of evidence-based methodologies, including pasteurization, to prepare safe milk for recipients.

2.15 Processing Fees--Fees assessed by the donor milk bank to offset the cost of donor screening, milk processing, storing, distribution, and record keeping.

2.16 Product Recall--The formal process of recalling all dispensed milk within a batch or batches that are suspected may potentially cause harm.

2.17 Product Replacement--The process of dispensing additional milk to a recipient or recipients after the initial dispensed milk has been identified as unacceptable, but not unsafe.

2.18 Quality Control Operation--A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the Code of Federal Regulations, Title 21, reserved for rules of the U.S. Food and Drug Administration.

2.19 Sanitize--Reduce microbial load to increase safety and decrease risk of contamination without adversely affecting the product or its safety for the consumer. An example of a sanitizing agent is 70% or higher isopropyl alcohol.

2.20 Sterilize--Destroy all microorganisms, including spores, via autoclave or other method(s) of sterilization.