Kristen Bishop MSN, RN, NE-BC, CPPS, OCN

Introduction/Problem Statement

What action should Pennsylvania take to improve access to human breast milk for infants who do not have access to their birthmother’s milk? 

Background

Breast milk is the only natural food source for human infants. Present day alternatives to breast milk include artificial infant formula and animal milk. Until the modernization of infant feeding nipples, bottles, formula, and refrigeration, the sharing of breast milk through wet nursing was the preferred option for feeding infants who could not be breastfed by their own birthmother (Stevens, Patrick, & Pickler, 2009). The older term “wet nurse” describes a woman who breastfed another woman’s child. The practice of hiring women to breastfeed an infant is no longer mainstream practice in US culture, but there is a growing movement of women sharing excess breastmilk with other mothers, referred to as “casual sharing”. 

There are many reasons infants may be unable to breastfeed. Infants who are orphaned during childbirth or who are adopted at birth do not have the opportunity to obtain breastmilk from their birthmother. Infants who are born premature or with oral motor issues may be physically unable to participate in breastfeeding. Additionally, there are clinical and ethical contraindications to breastfeeding an infant such as when a mother is capable of transmitting a disease.

Current clinical guidelines and research acknowledge that breastmilk is beneficial to human growth and development, but available resources and support are aimed solely at the birthmother-infant dyad. Resources and support for obtaining breastmilk have not been fully addressed for mothers who are unable to lactate, or infants without access to their birthmother. The American Academy of Pediatrics (AAP) proposes that infant nutrition should be viewed as a public health issue and not as a lifestyle choice (2012). The stakeholders who may be impacted by this discussion of access to human breast milk are infants, families of infants, legislators, public health entities, physicians, health care providers, human milk banks, and infant formula manufacturers.

Discussion

Current Infant Feeding Options: At the beginning of the twentieth century, artificial infant formula was marketed solely to physicians who had assumed the responsibility for approving the quality and safety of formulas through the American Medical Association (Stevens, Patrick, & Pickler, 2009). The Infant Formula Act of 1980 gave the Food and Drug Administration (FDA) oversight of infant formula, which led formula manufacturers to switch from marketing solely to physicians, to marketing to the public, Id.

Today’s infant formula industry is a $70 billion business and is made and marketed through a global industry system which is not regulated or monitored at the international level. The nutritional requirements of infant formula is guided by the global Codex Standard for Infant Formula resulting in a relatively uniform product, however manufacturers have great discretion on how they market the product. Some manufacturers have been found to market formulas differently in different countries, by claiming the benefits of a specific ingredient in one country but removing the same ingredient for health benefits in other countries (Changingmarkets, 2018). Formula manufacturers are accused of unethical marketing trends which include promoting formula as a premium product by adding unnecessary ingredients, promoting formula as a convenience, and lobbying against breastfeeding initiatives and legislation, Id. Because infant formula is classified as a food instead of a medicine, manufacturers are not required to offer information regarding the risks or side effects of use as they would be if formula were considered a pharmaceutical (Kent, 2015). In addition, most states do not have restrictions on infant formula manufacturers promoting their products to hospitals and new mothers. The success of aggressive marketing tactics by infant formula manufactures is one factor that has affected the decrease in breastfeeding rates in developed countries, dropping from 70% in the 1930’s to 14% in the 1970’s (Willumson, 2013). The World Health Organization advocates for the support of breastfeeding through restrictions placed on marketing of infant formula, Id. Other factors that have contributed to the decrease in breastfeeding are lack of community support, insufficient knowledge among health care professionals, cultural attitudes and workforce trends (USDA, 2001). 

Although modern formula provides adequate nutrition to sustain life, it is not a perfect replacement for human breast milk. The AAP recommends that infants consume breast milk exclusively for the first six months of life, and continue to at least one year of age as foods are introduced (2012). In addition, The American College of Obstetricians and Gynecologists, The American Academy of Family Physicians and The World Health Organization all recommend breastfeeding (Stuebe, 2009). 

While clinical guidelines and professional organizations all advocate that breastfeeding is the best option, research has shown that public perception in the U.S. views formula feeding as the norm (Stuebe, 2009). Research has also shown that exposure to infant formula marketing campaigns does influence a mother’s intention to use formula instead of breastfeeding (Zhang et al., 2013). 

Because breastfeeding promotion focuses solely on the birthmother-infant dyad, healthcare professionals are not trained to provide support services on all available alternative feeding options. Currently, most hospitals provide lactation consultant nurses to assist new mothers who have difficulties lactating, or whose infants have difficulty latching on to the breast or feeding. Lactation consultants may not provide support to mothers who are not lactating, even when an infant will not latch onto a bottle and is at risk for under-nutrition. It is possible to stimulate lactation in a woman who has not given birth both with and without medication, and to simulate breastfeeding using a dispensing device and donor milk yet neither of these options are being discussed or promoted in the U.S. healthcare industry. 

Breastmilk Research: Human breast milk is a complicated substance comprised of numerous cells which include proteins, stem cells and immune cells (Lonnderdal, 2003). Breast milk has been shown to change in response to the needs of the infant or mother, resulting in a product which is more than a food. Research shows that the white blood cell response in breast milk is stimulated by an infection in both the infant and the mother (Hassioutou et al., 2013). Research also shows that consumption of breast milk promotes infant brain development, with increases in both brain matter and cognitive ability (Isaacs et al., 2010). In addition, infants who are breastfed have lower incidences of ear infections, asthma, diabetes, sudden infant death syndrome and an overall decrease in infant mortality compared to formula fed infants (Stuebe, 2009). Stuebe also argues that breastfeeding reduces medical risks for both infant and mother, making it a modifiable risk factor for disease (2009). Mothers who do not breastfeed have a higher incidence of premenopausal breast cancer, ovarian cancer, weight gain, diabetes and myocardial infarction, Id.

Although breastmilk is the ideal source of nutrition for an infant, it is also a human body fluid which can transmit disease and drugs to an infant. Viruses such as Cytolomegalovirus (CMV) and Human Immunodeficiency Virus (HIV) can be transmitted through breast milk, and both prescription and street drugs such as cannabis or cocaine can be detected in breast milk (AAP, 2012). Because there is not enough research on the transmission of drugs through breastmilk, the FDA recommends lactating women and their physicians discuss the risks versus benefits of the use of drugs while breastfeeding (FDA, 2005). 

Researchers also argue that infant formula is nutritionally inadequate when considering it’s long term impact. Although most formula will not cause illness immediately, it is inferior to breastmilk in preventing major illnesses such as diabetes and asthma over the lifespan (Kent, 2015). 

Casual Sharing Movement: Today, women have the ability to quickly and easily express excess breast milk into storage containers for future use or sharing. Excess breast milk that is expressed can be stored in a freezer for up to 12 months (Office of Women’s Health, 2018). The current costs associated with breastmilk sharing are minimal, including the time for expression, the cost of supplies and refrigeration. The Human Milk Bank Association of North America (HMBANA) currently sets the standards for human milk donation process, pasteurization and dispensing in the U.S. HMBANA adopted it’s guidelines for screening, processing and dispensing human milk in collaboration with the Centers for Disease Control, (HMBANA, 2018). HMBANA also offers accreditation for non-profit milk banks, Id. Currently, there are 26 accredited milk banks in the United States making it a growing industry. Human milk which is donated to a bank is dispensed according to infant acuity, with medically fragile infants receiving available supply first. 

Because human milk sharing is not regulated, HMBANA and milk banks have implemented their own policies regarding milk processing, distribution and pricing. By requiring a physician prescription and using medical criteria to dispense, the system creates a limited use product and disparity for some infants. Mother’s who donate their breast milk do not participate in the distribution process, nor are they compensated. Mother’s and infants with a physician who is agreeable to providing a prescription may be able to obtain donor milk that is covered by insurance or Medicaid. But mother’s and infants who want donor milk that falls outside of the current medical criteria determined by the industry must pay out of pocket at rates set by the industry, and may have to wait for supply.

In addition to donor milk banks, casual sharing internet communities have become popular for connecting lactating women who want to share breastmilk with women who need breastmilk. Because casual sharing is a social community practice women rely on trust and social connections. One of the largest social sharing networks is Human Milk 4 Human Babies (HM4HB) which has a global network that connects mothers in over 50 countries (HM4HB, 2018). Within casual sharing communities, women with milk decide who they want to donate to and women who need milk decide who they want to receive from. The community does not allow milk to be sold, but does permit recipients to replace supplies. The exchange of breast milk happens in an agreed upon location such as a home or parking lot, and women rely on their own instincts to ascertain the health of the donor mother. As with all private ventures, there is fraudulent and unsafe activity which occurs, which can be harmful in the case of breastmilk sharing. Fraudulent activity includes diluting human breast milk with water or cows milk to increase the volume, which occurs when milk is being sold instead of donated (Dawson, D.S., 2011). Unsafe activity involves lack of sanitary processes in collecting, storing and transporting milk and sharing milk that has not been screened for disease or drugs, Id. 

National Landscape: Current legislation and support services at the federal level in the United States focus on promoting breastfeeding for the birthmother-infant dyad, and ensuring the rights of a mother to obtain protected work time and breastfeed in public. Absent from breastfeeding advocacy is the subject of access to breast milk for infants that cannot obtain it from their own birthmother, or support services for caregivers who are not lactating.

Currently, the FDA regulates scientific studies using breastmilk but does not regulate breast milk sharing, and recommends against using shared milk because of concerns with a lack of screening, processing and storing (FDA, 22 March 2018). There are no federal laws requiring donors or milk to be screened prior to sharing, and no laws prohibiting the sale of breastmilk. There are also no laws regarding the processing, storage or labeling of human milk. In addition, while the FDA regulates the donation of human tissue, cells, and cell/tissue based products intended to be transferred into a human, it specifically excludes human milk from the requirements which results in human milk being classified as a food (21 CFR Part 1270). When viewed as a food, USDA regulations under 21 CFR 110 apply, requiring that ingredients should not contain microorganisms that may produce food poisoning or should be pasteurized. It also specifies adequate manufacturing practices including pasteurization, handling and distribution to prevent food adulteration (Anderson, n.d.).

Because the federal government has chosen not to regulate breast milk donation, the issue is left to the states. The current question surrounding state regulation of human breast milk is whether to classify it as a food, medicine, or tissue (Campbell, 2016). New York, Maryland and California have chosen to classify human milk as a tissue, requiring donor banks to be regulated. Choosing to cIassify human milk as a tissue does have funding implications since foods can be charged to a hospital’s room and board, but tissue is billed to insurance (Campbell, 2016). In an outpatient setting, insurance companies do not cover foods, but will cover medicines.

Pennsylvania Landscape: In Pennsylvania, the only codified legislation related to breastfeeding is Senate Bill 34, permitting mothers to breastfeed in public (Pa. Cons. Stat. tit. 35 34 § 636.1). In June of 2018, legislators introduced the Keystone Mothers Milk Bank Act (House Bill 2516) to require milk banks in PA to be licensed through the Department of Health. The bill is currently tabled in the House of Representatives (PA General Assembly, 2018). It is important to note the language of the bill focuses on access to breast milk for “medically fragile” children only, and would not impact casual milk sharing between private parties (PA General Assembly, 2018). House Bill 2516 is written to license milk banks in Pennsylvania under similar requirements to blood banks. The regulations provide provisions for donor identification and screening, the collection, processing, storage and distribution of milk, and record retention regarding pasteurization, Id. The regulations also would require certification by HMBANA and the presence of a licensed director. 

In fiscal year 2017, 80.3% of WIC infant participants in Pennsylvania were fully formula fed (USDA, August 2018). The PA WIC program acknowledges that there is no better infant food than breastmilk. However, there is room for improvement in how WIC distributes food resources and promotes breastfeeding. The PA WIC website advertises that mother-infant dyads that fully breastfeed will receive more WIC foods than mother-infant dyads that formula feed only (Pennsylvania WIC, 2018). The PA Breastfeeding Referral Guide published by PA WIC and the PA Bureau of Family Health does not include resources related to donor milk or milk banking (PA Dept. of Health, 2014). The PA WIC Dietary Questionnaire for Infants under age one asks if babies are formula or breastfed, but does not include questions regarding the ability to breastfeed or access or need for breastmilk (PA WIC, 2015). 

In Pennsylvania, there are currently two accredited milk banks. The Mid-Atlantic Mothers Milk Bank accepts donations and distributes donor milk to medical facilities and the public with a physician’s prescription. The milk bank charges $3.95 an ounce to cover the cost of screening, supplies, and storage (Mid-Atlantic Mothers Milk Bank, 2018). CHOP Mothers Milk Bank is a part of Children’s Hospital of Philadelphia. The milk bank receives donations and dispenses donor milk only to patients of the hospital.

Fiscal Considerations: The Affordable Care Act requires marketplace plans to cover breastfeeding supplies, counseling and services both before and after birth. Plans must cover the cost of a breast pump and may cover other medically necessary services as recommended by the physician (Centers for Medicare & Medicaid Services, 2018). 

In addition, the federal government provides federal grants to states to operate the Women, Infant & Children (WIC) program which provides supplemental foods, education and health referrals to low income pregnant women, breast feeding and non-breastfeeding postpartum women and infants and children up to age five (USDA, 2018). In fiscal year 2018, Pennsylvania received $178,733,002 in WIC grant funding from the federal government (USDA, September 30, 2018). The federal WIC program supports breastfeeding by collecting and monitoring participant data regarding state breastfeeding and formula feeding. WIC provides state agency bonuses for breastfeeding performance measures. 

In 2017, the PA Department of Human Services approved Medicaid reimbursement for human milk banks, physicians, and hospitals that prescribe or provide donor breast milk for high risk infants (PA Dept. Human Services, 2017). It is important to note that these services are only focused on infants with specific medical conditions, and for situations where third party payment is involved.

For parents with out of pocket expenses, most generic formula has an average cost of $0.25 an ounce. Compare this to $3.45 an ounce for donor milk form the Keystone Milk Bank. An infant who consumes 25 ounces a day would incur costs of $6.25 a day for formula or $86.25 a day for donor milk. It is easy to see why parents, physicians and WIC choose formula over donor milk when cost is a factor. 

There are numerous grant opportunities which could be used to fund expanding the support services and access to breastmilk. Medela, W.K. Kellog Foundation, Aetna, USDA, and the United States Breastfeeding Committee are a few of the organizations that provide grants for research and support services for breastmilk and access to breastmilk. By increasing the donor pool for breastmilk sharing, applying for grants, and using rate caps the price of donor milk can become more attainable for more infants in Pennsylvania. 

Options

The issues surrounding the promotion of breastfeeding and access to breastmilk are multi-factorial, allowing room for multiple improvement approaches to how Pennsylvania designs support services for infants and mothers. As a modifiable risk factor for disease, breastfeeding promotion through the use of donor milk can help decrease health disparities and mortality and should have a larger focus within public health campaigns and support services being offered in Pennsylvania. The goal of any regulation should be to support and encourage infant consumption of breastmilk in a safe manner.

Option 1:  Regulate the Exchange of Human Milk As a Pharmaceutical of Tissue

While breastmilk has been used and shown to improve and prevent neonatal illness such as Necrotizing Enterocolitis, classifying breastmilk as a pharmaceutical or tissue may initially place a burden on donors, recipients and providers.  Currently, milk banks in Pennsylvania do not dispense donor milk without a physician prescription so that they can receive payment from insurance companies and Medicaid. Regulations would need to be adopted or amended related to prescribing, storage, dispensing, use, and insurance coverage. Requiring a physician prescription for all milk sharing may prevent recipients from participating in seeking donor breastmilk. 

Breastmilk has not been shown to have any substances that cause compatibility issues when shared, such as in the case of blood types. Therefore, donors and recipients do not need to be matched. Breastmilk will only need to be screened for disease and drugs, and pasteurized for storage. 

Option 2: Regulate the Exchange of Human Milk as a Food

If classified as a food for regulatory purposes, human milk processing should meet all regulations required for food processors under PA law. While classified as a food, human milk would not require a physician prescription and it would be able to be dispensed without using medical acuity guidelines. As a food it also would not require screening for disease, but not doing so would be unethical and unsafe.  

Option 3: Expand Education and Support Services Already in Place to Support Alternative Infant Feeding Options

Currently, breastfeeding support services in Pennsylvania are designed around the birthmother-infant dyad, and infant feeding options are viewed solely as bottle or breast. Expanding breastfeeding resources to include support for alternative feeding options will allow more infants to benefit from access to human milk and alternative feeding options. 

In addition, the donor milk banking industry is new and focused on a very narrow population of infants. Increasing advocacy and educational efforts around milk sharing will increase the pool of donors and milk supply. Expanding WIC coverage to include the cost of donor human milk will help decrease overall consumption of formula. 

Conclusion / Recommendation

A combination of Option 1 and Option 3 will best meet the needs of Pennsylvania residents. House Bill 2516 should be amended to classify breastmilk as a tissue, and require appropriate licensing, screening, collection, storage, and dispensing as such. In addition, the sale of breastmilk among private parties should be prohibited. Regulations should allow donor breastmilk to be available for any need specified by a physician, and not restricted to medical acuity or specific diagnoses. In order to do this, donors and donor milk reserves will need to increase substantially which will require the expansion of current education and support services being offered. The following are some specific recommendations to support this effort. 

Require all licensed health care facilities and providers that provide maternity, prenatal, or newborn services to have an infant feeding consultant available to provide information and resources regarding breastfeeding, donor milk banking and alternative feeding options.

Require infant feeding assessments, education, and resources be provided for all new mothers and newborn caregivers at the time of birth, regardless of lactation ability. Include education on how non-lactating women can stimulate breastmilk production.

Create an electronic database to track donors and recipients based on location. Recipients and donors should have the ability to update their profile as circumstances change, resulting in a real time picture of availability and need. 

Require hospitals and birth centers to provide information on donor eligibility at the time of birth. Because women who give birth under medical supervision are already being medically screened, presenting the option to join the registry at birth could increase donor pools exponentially. 

Place restrictions on formula manufacturers marketing to hospitals and birth centers in Pennsylvania.

Expand WIC support to include donor milk. 

Monitor the price of donor breastmilk and take measures to ensure out of pocket cost is capped. 

Department of Health and WIC can participate in more grant funding opportunities focused on donor milk sharing. 

Require milk banks to provide education to the public and all healthcare providers in Pennsylvania, not just hospitals. 

Endnotes

21 CFR § 1270.3 (1997) Human Tissue Intended for Transplantation. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1270

The American Academy of Pediatrics. (2012) Breastfeeding and the use of human milk. Retrieved from http://pediatrics.aappublications.org/content/129/3/e827.full#content-block

Anderson, N. (n.d.) FDA Regulations and Process Validation Considerations. Retrieved from http://www.nifa.usda.gov/sites/default/files/resource/Overview%20of%20FDA%20Regulations%20And%Process%20Validation%20Considerations.pdf

Campbell, O. (2016) When babies need donated breast milk, should states pay? Retrieved from https://www.scientificamerican.com/article/when-babies-need-donated-breast-milk-should-states-pay/

Centers for Medicare & Medicaid Services (2018) Breastfeeding benefits. Retrieved from https://www.healthcare.gov/coverage/breast-feeding-benefits/

Changing Markets Foundation (2017). Milking It. Retrieved from https://changingmarkets.org/wp-content/uploads/2017/10/Milking-it-Final-report-CM.pdf

Council of State Governments (CSG). (2014) Policy & Research. Retrieved from https://www.csgmidwest.org/policyresearch/qom-1214.aspx

Dawson, D.S. (2011) Legal Commentary on the Internet Sale of Human Milk. Public Health Reports. 126(2): 165-166. 

Food and Drug Administration. (2005) Guidance for industry-clinical lactation studies. 

Retrieved from https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127505.pdf

Food & Drug Administration. (22 March 2018) Use of Donor Human Milk. Retrieved from  https://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/ucm235203.htm

Hassioutou, F., Hepworth, A.R., Metzger, P., Tat Lai, C., Trengove, N., Hartmann, P.E. and Filguerria, L. (2013). Maternal and infant infections stimulate a rapid leukocyte response in breastmilk. Clinical Translational Immunology. (2)4:e. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25505951

Human Milk 4 Human Babies. (2018) About Us. Retrieved from http://hm4hb.net/about-us/

Human Milk Bank Association of North America (2018) Our Work. Retrieved from https://www.hmbana.org/our-work/

Isaacs EB, Fischl BR, Quinn BT, Chong WK, Gadian DG, Lucas A. Impact of breast milk on intelligence quotient, brain size, and white matter development. Pediatr Res. 2010;67(4):357–362pmid:20035247. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2939272/

Kent, G. (2015) Global infant formula: Monitoring and regulating the impacts to protect human health. International Breastfeeding Journal. 10:6. Published online at www.ncbi.nlm.nih.gov/pmc/articles/PMC4362817/

Khazan, O. (2018) The epic battle between breast milk and infant formula companies. Retrieved from www.theatlantic.com/health/archive/2018/07/the-epic-battle-between-breast-milk-and-infant-formula-companies/564782/

Lonnerdal, B. (2003). Nutritional and physiological significance of human milk proteins. American Journal of Clinical Nutrtition. 77(6): 1537-1543. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/12812151

Mid-Atlantic Mothers Milk Bank (2018) Ordering. Retrieved from https://midatlanticmilkbank.org/order/

Office of Women’s Health (2018) Pumping and storing breast milk. Retrieved from https://www.womenshealth.gov/breastfeeding/pumping-and-storing-breastmilk

Pa. Cons. Stat. tit. 35 § 636.1 et seq. (2007) Freedom to Breastfeed Act. Retrieved from https://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=HTM&sessYr=2007&sessInd=0&billBody=S&billTyp=B&billNbr=0034&pn=1045

Pa. Department of Health (2014) Pennsylvania Breastfeeding Referral Guide. Retrieved from https://www.pawic.com/documents/PA%20Breastfeeding%20Referral%20Guide.pdf

Pa. Department of Human Services. (August 7, 2017) Medical Assistance Bulletin. Retrieved from http://www.dhs.pa.gov/cs/groups/webcontent/documents/bulletin_admin/c_264241.pdf

Pa. General Assembly. (September 25, 2018) House Bill 2516. Retrieved from https://www.legis.state.pa.us/cfdocs/billInfo/bill_history.cfm?syear=2017&sind=0&body=H&type=B&bn=2516

Pennsylvania  WIC (2015) Dietary Questionnaire for Infants. Retrieved from https://www.pawic.com/documents/PAWIC-dietary-questionnaire-infants.pdf

Pennsylvania WIC. (2018) How WIC Promotes Breastfeeding. Retrieved from https://www.pawic.com/HowWicPromotesBreastfeeding.aspx

Stevens, E.E., Patrick, T.E., & Pickler, R. (2009) A history of infant feeding. Journal of Perinatal Education. 18(2): 32-39. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684040/

Stuebe, A. (2009) The risks of not breastfeeding for mothers and infants. Reviews in Obstetrics and Gynecology. 2(4): 222-231.

United States Department of Agriculture (USDA). (2018, September 30) FY2018 WIC Grants. Retrieved from https://www.fns.usda.gov/wic/wic-funding-and-program-data

United States Department of Agriculture (USDA). (2018). Women, Infants, and Children(WIC). Retrieved from https://www.fns.usda.gov/wic/women-infants-and-children-wic

United States Department of Agriculture (USDA). (2001). The Economic Benefits of Breastfeeding: A Review and Analysis. Retrieved from http://www.aeped.es/sites/default/files/6-economic_benefits.pdf

Willumson, J. (2013). Regulation of marketing breastmilk substitutes. Retrieved from https://www.who.int/elena/bbc/regulation_breast-milk_substitutes/en/

Zhang, Y., Carlton, E. & Fein, SB. The association of prenatal media marketing exposure recall with breastfeeding intentions, initiation, and duration. Journal of Human Lactation. 29(4): 500-9.