Donated breast milk, known as donor human milk, is a feeding option for vulnerable infants whose mothers cannot provide their own milk. This milk is primarily processed and distributed through non-profit human milk banks, such as those accredited by the Human Milk Banking Association of North America (HMBANA). The safety of this milk is ensured through a highly regulated, multi-step process. This comprehensive regulation creates a significant distinction between formally donated milk and milk shared informally between individuals.
Rigorous Donor Screening in Milk Banking
Safety begins with a rigorous screening process focused entirely on the prospective donor. Milk banks only accept volunteer donors who are healthy, lactating mothers with a surplus of milk, eliminating any financial incentive for dishonest reporting. Every potential donor must complete a comprehensive medical and lifestyle history questionnaire.
This detailed assessment screens for potential risks such as smoking, daily alcohol consumption, and the use of unapproved medications or herbal supplements. A medical release is obtained from the donor’s healthcare provider to confirm their overall health status. Mandatory blood testing screens the donor’s serum for infectious diseases that could be transmitted through milk.
The required serological tests include screening for Human Immunodeficiency Virus (HIV-1 and HIV-2), Human T-cell Lymphotropic Virus (HTLV-1 and HTLV-2), Hepatitis B and C, and Syphilis. Donors are disqualified if any of these tests return a positive result or if they have certain risk factors, such as a partner at risk for HIV. This multi-layered screening process ensures the milk collected is from a low-risk source.
Pasteurization and Quality Testing Procedures
After collection, the raw donor milk undergoes a specific heat treatment and testing protocol to neutralize potential pathogens while preserving much of its nutritional content. Milk from multiple qualified donors is often pooled to ensure a consistent nutritional and caloric content across the batch. This pooled milk is then transferred into bottles for pasteurization.
The standard treatment method used by HMBANA-accredited banks is Holder Pasteurization. This gentle process involves heating the milk to 62.5°C (144.5°F) and maintaining that temperature for exactly 30 minutes. This combination is designed to inactivate bacteria and viruses, including HIV, while minimally impacting the milk’s beneficial components. Following the heat treatment, the milk is rapidly cooled to preserve its quality.
The final step is post-pasteurization microbiological testing before any milk is dispensed. A sample from each processed batch is sent to an independent, accredited laboratory to be cultured for bacterial growth. Only batches that demonstrate a negative culture, confirming the absence of harmful bacteria, are approved for use. This combination of donor screening, heat treatment, and post-processing culture provides assurance regarding the milk’s sterility and safety.
Why Informal Milk Sharing Carries Risks
The rigorous safety standards of non-profit milk banks stand in stark contrast to the unregulated practice of informal milk sharing, which often occurs peer-to-peer or through online platforms. Informal sharing bypasses the safety protection tiers that formal milk banks implement. The most significant risk is the lack of mandatory donor blood screening for infectious diseases such as HIV and Hepatitis, meaning the recipient has no guarantee of the donor’s health status.
Milk acquired through these informal channels may contain drug residues, alcohol, or nicotine, as the donor’s lifestyle is not formally verified. The milk’s safety is also compromised by the potential for bacterial contamination due to improper collection, handling, or storage conditions. Variations in freezer temperature or the use of unsterile containers can allow harmful bacteria to proliferate.
Informal sharing lacks the necessary post-collection heat treatment, meaning that any pathogens or bacteria present in the raw milk are not neutralized. The U.S. Food and Drug Administration and major medical organizations actively discourage unregulated milk sharing because the safety cannot be definitively answered. Without the oversight of a milk bank, the recipient is solely responsible for evaluating the unknown risks, including exposure to infectious agents and environmental contaminants.
Medical Need and Access for Recipients
Donated human milk is recognized as the second-best feeding option after a mother’s own milk, especially for vulnerable infants. The primary recipients are extremely premature infants who are at high risk for serious complications. Human milk provides unique immunological components that offer protection against necrotizing enterocolitis (NEC).
Studies have consistently shown that feeding premature infants human milk significantly lowers the incidence of NEC compared to formula feeding. Donor milk is also administered to infants whose mothers have a medical condition preventing them from providing their milk or those who have an insufficient supply. Access to pasteurized donor human milk typically requires a prescription from a healthcare provider. The milk is most often administered in a hospital setting, particularly in Neonatal Intensive Care Units (NICUs), where it is integrated into the care plan for these fragile patients.