Use of Banked Human Breastmilk in the WIC Program

The purpose of this memorandum is to clarify FNS policy regarding breast milk from a human milk bank as an allowable substitute for WIC-eligible formulas. In the past, FNS has authorized BBM on a case by case basis. However, because quality and safety standards for human breast milk banks vary and are unregulated, FNS will no longer authorize BBM as a WIC-eligible formula.

Recognizing that no federal health and safety standards exist governing the operation of milk banks, which potentially places WIC participants at risk from contaminated or otherwise unsafe breast milk, FNS has decided to discontinue its authorization. In addition, provision for mandatory pathogen, drug, toxin and allergen screening are lacking. Further, BBM must be pasteurized which may cause it to lose some of its intrinsic nutritive value.

It is not possible to protect FNS from liability if a WIC participant who is authorized BBM is harmed from contaminated or otherwise unsafe breast milk. FNS does not have the statutory authority to promulgate, evaluate, or approve health and safety standards for human breast milk storage facilities. As such, to protect the well being of infant participants in the WIC program and to avoid placing FNS and WIC state agencies in a vulnerable position concerning the liability aspects of providing BBM, we have determined that BBM should no longer be authorized as an allowable substitute for WIC-eligible formulas.

PATRICIA N. DANIELS
Director
Supplemental Food Programs Division