Actors with a vested interest in PAMS policy include, are not limited to, and listed in no particular order of efficacy are PAMS donors and recipient families, recipient infants, professional organizations of health care providers, state and federal departments of public health, state and federal legislators, state and federal food safety departments, researchers in the field of lactation, the Human Milk Banking Association of North America (HMBANA), for profit milk banks and cooperatives, lactation freedom and rights activists, the media, and private sellers of breastmilk. Discussing the level of involvement and impact of each of these actors is beyond the scope of this blog, but I will offer a few thoughts concerning the media, research, and milk banks/cooperatives (HMBANA, Prolacta Bio Sciences, and Mother’s Milk Cooperative). Inaccurate interchange of PAMS and private sale of milk intentionally or out of ignorance found everywhere from the blogging community to well respected research journals, to intended legislation (Geraghty et al., 2011, Keim et al., 2013a; Keim et al., 2013b; Assembly Bill 1857), fuels confusion and reduces efficacy of dialog surrounding PAMS.
The media has a delicate place in PAMS policy. In the short history of PAMS, it has been labeled as risky (“Milk Sharing for Babies Risky, FDA Says”, “ Booming Demand For Donated Breast Milk Raises Safety Issues”, “Websites for Sharing Breast Milk Raise Concerns About Health Risks”) or sensationalized for the potential involvement of lactophiles. Attempts to discuss milk-sharing risks in context are not well received. The role of the media in matters of lactation in general is not a positive one. Breastfeeding rarely appears in modern television. Predatory advertisement by formula companies airs frequently. Unfortunately, this type of media attention creates great difficulty in beginning dialog which would be conducive to an informed and activated public, and responsive political representatives (Kingdon, 2003).
As a researcher involved in an area facing questions of policy, I have a bit of a bias as to how important research should be in making policy. The nature of breastmilk as a biological resource, source of nourishment, and commodity makes a brief discussion of the role of research difficult. With respect to PAMS in the current environment, the role of research comes down to a few key need-to-knows-
- What is PAMS?
- Who is participating in PAMS, how are they participating, and what impact is PAMS milk having on infant feeding practices?
- What precautions are being taken in screening of participants and handling of milk to mitigate risks to participants and recipient infants?
- What does the practice of PAMS mean for families involved?
- What are the potential and probable health impacts of PAMS in the context of the current extent of involvement of the child rearing community?
The answers to these questions will make it possible to determine the urgency of policy and potential regulation, as well as the most effective means to reach participants and providers to facilitate infant safety without alienating a sub-culture or infringing on the rights of families.
Milk banks associated with HMBANA are currently the only recommended source of obtaining breastmilk outside the breastfeeding dyad in the United States (FDA, AAP, CDC, etc). These 11 banks are not capable of consistently meeting the needs of the hospitalized infants that make up the primary recipients of their milk, let alone providing milk for otherwise healthy infants. Availability from cooperative sources or from for-profit banks has not been documented. The restrictions placed on donors by these centralized organizations are many. These restrictions create a lack of available donors meeting acceptance criteria. Not all of the restriction to donation, such as history of residence in the United Kingdom, are particularly well grounded in evidence. These restrictions create a forced shortage of an already precious commodity. It is not surprising then that HMBANA would seek, even in light of there being no evidence of significant overlap of the donor populations of the bank v. PAMS to date (Gribble, 2013), to discourage the practice –
The practice of casual sharing of milk or procuring milk from any source other than an
established donor human milk bank operating under HMBANA Guidelines, or similar guidelines
established in other countries, has potential risks for both the recipient and the donor or her
child. HMBANA does not endorse the practice of selling or purchasing human milk, human milk components or human milk by-products.
Again, note the incorrect assumption that PAMS = selling milk. Also note the language of exclusion in assuming that the practice of distributing breastmilk is solely the undertaking of women, presumed to be the mothers.
Regulation and Statute of Human Milk
David (2011) describes the current statute and regulation of selling milk in the United States regarding potential for litigation. In short –
- The National Organ Transplant Act and state interpretations of it does not cover the sale [or sharing] and transportation of breastmilk, semen, hair and other replenishing body fluids.
- Criminal liability could be sued on the grounds of having knowingly sold [or shared] breastmilk when the donor has tuberculosis, syphilis, HIV, or other infectious disease which may be transmitted in breastmilk. Federal jurisdiction over shipping an infectious fluid may be arguable in these circumstances as well.
- Tax law could be used to hold sellers responsible for profits of milk sales.
- Laws in Texas, California, and New York regarding sale [or sharing] of human milk only apply to licensed donor banks.
In 2010, a bill was introduced in Tennessee that would have made selling human milk a misdemeanor. It did not pass committee. In 2013, a bill was passed in the New Jersey State Assembly to create a public health education campaign regarding the dangers of PAMS and of private sale of human milk. This bill was not voted on by the state Senate. In 2014, this bill was renamed and reintroduced for consideration by committee.
Commentary regarding the safety of PAMS in comparison to HMBANA banks reference the standards of screening and handling which are assumed to be exceptional, and the regulation of the banks. HMBANA is a professional organization which acts as a liason between member banks and federal agencies of potential oversight and regulation. Regulation of HMBANA does not exist beyond the legislation in California, Texas, and New York regarding donor recruitment and milk sales practices. In the case of California and Texas, the standards set by HMBANA for their own processing are the standards used in the legislation (FDA, 2010). Contrary to the assertions of many authors, adherence to HMBANA standards is NOT compulsory, even for member banks (FDA, 2010). By contrast, as a for-profit entity, Prolacta Biosciences is subject not only to the standards of HMBANA by proxy of those being the regulatory standards legislated in California, but by direct oversight of the FDA (Prolacta, 2013). As a result of the increased scrutiny Prolacta operates under, additional safety and accountability measures (such as DNA matching received serum samples to the accompanying milk) are undertaken (Prolacta, 2013). Mother’s Milk Cooperative was founded by former associates of Prolacta, and operates with greater attention to control and assessment of milk quality than HMBANA. It should be noted that the additional scrutiny in milk banking is not supported by evidence, as there have been no reports of infant illness or death attributed to milk obtained from milk banks in the United states.
There are many actors involved in the pending process of health policy making concerning PAMS and the distinct but related practice of private milk selling. Some actors have a vested interest in discouraging the practice, potentially to the extent of seeking to outlaw it. The differential of power and motivation of all actors has yet to be explored with respect to policy making. Current policy regarding regulation of milk banking, its application to PAMS, and even its efficacy for milk banks is ambiguous. This shaky foundation and lack of clear definition of actors and statute create unique challenges to expediency and opportunities for closing gaps in consistent application of health policy regarding human milk.
A.R. 1857, 216th Legislature (New Jersey 2014).
David, S. D. (2011). Legal commentary on the internet sale of human milk. Public Health Reports (Washington, D.C. : 1974), 126(2), 165-166.
Food and Drug Administration. (2010). Banked Human Milk Backgrounder.
Gribble, K. D., & Hausman, B. L. (2012). Milk sharing and formula feeding: Infant feeding risks in comparative perspective? The Australasian Medical Journal, 5(5), 275-283.
H.R. 3704, 106th General Assembly (Tennessee 2010).
Keim SA, McNamara KA, Jayadeva CM, Braun AC, Dillon CE, Geraghty SR. (2013) Breast milk sharing via the Internet: the practice and health and safety considerations. Maternal Child Health.
Kingdon, J. W. (2003). Agendas, alternatives, and public policies. New York: Longman.
Prolacta Biosciences. (2013). Prolacta’s state-of-the-art testing, screening, and standardized production process. Retrieved from http://www.prolacta.com/quality/
Sakamoto, P. (2010). Human milk banking association of North America. Brief for the United States Food and Drug Administration.