Safety of Donor Human Milk in Canada

Health Canada advises Canadians to be aware of the potential health risks associated with consuming human breast milk obtained through the Internet or directly from individuals.

There is a potential risk that the milk may be contaminated with viruses such as HIV or bacteria which can cause food poisoning. In addition, traces of substances such as prescription and non-prescription drugs can be transmitted through human milk. Improper hygiene when expressing the milk, as well as improper storage and handling, could also cause the milk to spoil or be contaminated with bacteria and/or viruses that may cause illness.

Health Canada recommends that Canadians consult their health care professional should they have questions about breastfeeding or if they are considering purchasing donor human milk.

Questions and Answers

What is donor human milk?

Breastfeeding provides nutritional, immunological, and emotional benefits to infants and young children. Health Canada and healthcare professionals promote breastfeeding as the normal method for feeding infants and it is recognised internationally ( WHO/ UNICEF). For selected infants whose mothers are not able to provide a full volume of breastmilk, donor human milk (DHM) may be an alternative nutrition source. Such milk should be obtained from a reliable source such as a recognized human milk bank.

Who most often requires DHM?

Mothers of preterm infants face challenges in providing sufficient milk for their infant during hospitalization. This is for a variety of reasons, including immaturity of the mammary glands as well as maternal illness. Typically, these infants are in neonatal intensive care units (NICUs).

Why is the sharing or use of DHM under scrutiny? Is consumption of DHM a risk for illness or disease?

In Canada, milk banks are now operating in Calgary, Montreal, Toronto and Vancouver. It should be noted that milk from these banks is only available in limited quantities. In fact, DHM from these banks is prioritized to high risk infants in the NICU. Therefore, many mothers have turned to private individuals or to the Internet to obtain milk, sometimes as part of a sharing program.  The safety of milk from these sources is questionable, as these sources are not known to have undergone any form of oversight of the screening, processing, storage of DHM or medical history and screening of the donor.

There is a potential risk that DHM may be contaminated with harmful substances. Microbial hazards include viruses such as HIV, hepatitis B and C, cytomegalovirus and human T cell leukemia virus and/or bacteria such as E. coli, Salmonella or Staphylococcus aureus. There is also the potential for chemical contamination. Traces of substances such as prescription and non-prescription drugs, among other contaminants, can be transmitted through human milk. Improper hygiene when expressing the milk, as well as improper storage and handling, could also cause the milk to spoil or be contaminated with bacteria and/or viruses that are human health hazards. There is also a potential for adulteration (i.e., substitution with diluted cow's milk, etc.) when obtaining human milk from the Internet and from individuals.

What is the opinion of the Canadian Paediatric Society on the use of DHM?

The Canadian Paediatric Society (CPS) recommends against the sharing of unprocessed human milk ( Kim et al., 2010). The preferred nutrition for the infant is his/her own mother's milk. When the latter is not available or is limited, pasteurised DHM is one of the recommended alternatives for hospitalised neonates due to the limited quantity presently available. CPS represents over 2500 specialists including paediatricians, and agrees with Health Canada's recommendations on the use of donor human milk.

What is Health Canada's position on the sharing or use of unprocessed DHM?

Health Canada recommends against the consumption of unprocessed DHM obtained from private sources such as the Internet or from private individuals.  Health Canada recommends that Canadians consult their health care professional, should they have questions about breastfeeding or if they are considering obtaining human milk from an alternative source to determine if it is the best and safest option for their infant.

What is the role of Health Canada in regulating DHM?

When intended for consumption as a food, the sale and distribution of DHM is considered a food and therefore, the sale or distribution of DHM in Canada is regulated under the  Food and Drugs Act and  Regulations. As a food, DHM must meet all provisions in the Food and Drugs Act and Regulations. The Canadian Food Inspection Agency is responsible for enforcing all provisions of the Food and Drugs Act with respect to food, as well as the associated policies established by Health Canada. DHM must adhere to sections 4 and 7 of the Food and Drugs Act. DHM bank facilities may be inspected by the CFIA to ensure safety.

What action has Health Canada taken to inform the public about the risks associated with DHM?

Health Canada has issued an information update to Canadians regarding the purchase of human milk obtained from the Internet; milk sharing programs; or purchasing from private individuals. Health Canada is committed to maintaining and improving the health and well-being of Canadians and therefore aims to ensure that parents are aware of the potential health and safety risks associated with consuming unprocessed DHM obtained through alternative sources.

Where is human milk officially banked in Canada?

There are currently four human milk banks in Canada operating in Calgary, Montreal, Toronto, and Vancouver. These milk banks abide by strict operating procedures, which include donor screening, medical supervision, bacteriological testing, pasteurisation, storage, and distribution. DHM from the milk banks in Canada is only available by prescription and according to a specified need.

What are the safe practices used by donor human milk banks?

Human milk banks are not for profit organizations. Donor mothers donate their milk for philanthropic reasons and are never paid for their donation. There is a rigorous screening procedure that takes place prior to donating milk, including a comprehensive medical and lifestyle interview, approval from a physician and serological testing for several diseases. This testing is repeated on a semi-annual basis. Exclusion factors include taking prescription drugs, chronic infections and smoking. After passing all of the strict screening procedures, donor mothers are educated on safe handling and storage techniques. The expressed milk is frozen, stored and transported to the milk bank for further processing (Human Milk Banking Association of North America, 2013).

When DHM reaches the milk bank, it is thawed, cultured to determine the bacterial content and pooled to blend for constituent variation. Pooled DHM that meets the standard is pasteurized using the Holder method (62.5°C for 30 minutes), which achieves the equivalent level of microbiological safety required for other commercial liquid milk sold in Canada. After pasteurization, another microbial screening is performed to ensure the absence of all microorganisms. The milk is then frozen and stored.

What action has been taken internationally to promote infant/consumer safety with respect to unprocessed DHM?

The United States and France have similar positions on unprocessed DHM. The safety of unprocessed DHM was discussed by the US Food and Drug Administration (FDA) who  recommended against its use. France has also  issued similar warnings against the sharing and use of unprocessed DHM. La Leche League International also issued  guidance on the human milk sharing, however, they do not provide guidance on the handling and storage of DHM.

References

• Human Milk Banking Association of North America. Guidelines for the Establishment and Operation of Donor Human Milk Bank. 2013.