Existing law, with certain exceptions, requires a tissue bank operating in California to have a current valid license issued by the State Department of Public Health. Existing law defines a tissue bank as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Existing law defines tissue to include human bodily fluids, and defines transplantation to include by ingestion. The department may suspend or revoke a tissue bank license for specified reasons. A violation of the provisions regulating tissue banks is a misdemeanor.

This bill would define a human milk tissue bank as a tissue bank that provides financial compensation to a participating mother for procuring human milk for the purpose of human consumption, and would define a participating mother as a woman who provides her human milk to a human milk tissue bank in exchange for financial compensation. The bill would require a human milk tissue bank licensed by the department that collects, processes, stores, or distributes human milk to, among other things, work with lactation support groups to provide breastfeeding education and lactation support for a participating mother, from whom the tissue bank procures human milk, as provided. The bill would prohibit a human milk these tissue bank banks from, among other things, procuring human milk from providing payment to a mother for human milk the tissue bank procures from her within her first 180 90 days postpartum. The bill would require the department to adopt, on or before January 1, 2018, rules and regulations governing a human milk these tissue bank banks that, at a minimum, are substantially based upon the guidelines of the Human Milk Banking Association of North America for safely procuring, processing, storing, and distributing human milk, and would require a human milk these tissue bank banks to comply with the latter guidelines until the department adopts those rules and regulations. The bill would provide that a violation of its provisions is not punishable as a misdemeanor under existing law. The bill would provide that its provisions remain in effect only until January 1, 2022.

Existing law, with certain exceptions, requires a tissue bank operating in California to have a current valid license issued by the State Department of Public Health. Existing law defines a tissue bank as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Existing law defines tissue to include human bodily fluids, and defines transplantation to include by ingestion. The department may suspend or revoke a tissue bank license for specified reasons. A violation of the provisions regulating tissue banks is a misdemeanor.

This bill would define a human milk tissue bank as a tissue bank that provides financial compensation to a participating mother for procuring human milk for the purpose of human consumption, and would define a participating mother as a woman who provides her human milk to a human milk tissue bank in exchange for financial compensation. The bill would require a human milk tissue bank to, among other things, work with lactation support groups to provide breastfeeding education and lactation support for a participating mother, as provided. The bill would prohibit a human milk tissue bank from, among other things, procuring human milk from a mother within her first 180 days postpartum. The bill would require the department to adopt, on or before January 1, 2018, rules and regulations governing a human milk tissue bank substantially based upon the guidelines of the Human Milk Banking Association of North America for safely procuring, processing, storing, and distributing human milk, and would require a human milk tissue bank to comply with the latter guidelines until the department adopts those rules and regulations. The bill would provide that a violation of its provisions is not punishable as a misdemeanor under existing law.

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 1316 (Wolk) - Tissue banks: human milk

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

SB 1316 would place specific regulatory requirements on tissue banks that collect, process, store, or distribute human milk.

Fiscal Impact:

Ongoing costs of $150,000 per year for the Department of Public Health to develop and adopt regulations and to license and enforce licensing requirements on those banks that manage human milk (Tissue Bank Special Fund).

Background:

Under current law, tissue banks are licensed by the Department of Public Health. Any facility that collects, processes, stores, or distributes tissues requires a license. “Tissue” is defined to include cells, blood, bodily fluids (including breast milk) and other tissues. Under current law, there are 95 tissue banks in the state that include human milk among their transplantable tissues. Most of those licensees are hospital-based tissue banks. There are also five tissue banks that collect and process human milk, one that collects unprocessed milk, and two that collect and store unprocessed milk.

There is a national umbrella group of non-profit organizations that collect and distribute donated human milk. This group, the Human Milk Banking Association of North America (HMBANA) has developed voluntary guidelines for human milk banks. Those guidelines include requirements for safe handling of human milk and restrictions on donors (for example, excluding donors based on drug or alcohol use). HMBANA members are non-profit entities that rely on donated human milk.

Proposed Law:

SB 1316 would place specific regulatory requirements on tissue banks that collect, process, store, or distribute human milk.

Specific provisions of the bill would:

• Require licensed tissue banks that collect, process, store, or distribute human milk to comply with the guidelines developed by the Human Milk Banking Association of North America until the Department of Public Health adopts regulations;
• Require tissue banks to work with lactation support groups to provide lactation support to a mother who provides human milk to a tissue bank;
• Require tissue banks to disclose the intended purposes of the procured milk to the mother;
• Prohibit tissue banks from providing payment to a mother for human milk within 90 days postpartum;
• Prohibit tissue banks that provide compensation to mothers from using the term “community benefit”;
• Require the Department of Public Health to adopt regulations governing tissue banks that are substantially based on the guidelines of the Human Milk Banking Association of North America;
• Include a January 1, 2022 sunset date on the bill’s requirements.

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SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 1316

SUBJECT: Tissue banks: human milk

SUMMARY:

Requires a “human milk tissue bank,” as defined, to comply with specified nationally recognized guidelines, and the Department of Public Health to adopt rules and regulations, for the safe procuring, processing, storing, and distributing of human milk that is collected from a “participating mother,” as defined.

Existing law:

1. Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the Department of Public Health (DPH), with the following exceptions:
   1. Licensed blood banks;
   2. Entities collecting, processing, storing or distributing tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation where transplantation of the tissue is not intended;
   3. A licensed physician and surgeon collecting tissue from his or her patient, or the implantation of tissue into his or her patient. This exemption does not apply to any processing or storage of the tissue, except for the processing and storage of semen collected from a semen donor or obtained from a licensed tissue bank;
   4. The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus;
   5. The collection, processing, storage or distribution by an organ procurement organization;
   6. The storage of prepackaged, freeze-dried bone by a general acute care hospital;
   7. The storage of freeze-dried bone and dermis by a licensed dentist, provided that it has been obtained from a licensed tissue bank and stored in accordance to the manufacturers' instructions and is used for the express purpose of implantation into a patient; and,
   8. The storage of a human cell, tissue, or cellular- or tissue-based product that is either a medical device approved by the federal Food and Drug Administration (FDA), or that is a biologic product approved under the federal Public Health Service Act by a licensed physician or podiatrist. The medical device or biologic product must have been obtained from a licensed tissue bank, been stored in accordance with the device's or product's package insert and any other manufacturer instruction, and be used solely for the use of direct implantation into or application on the practitioner's own patient.
2. Defines “tissue” as a human cell, group of cells, including the cornea, sclera, or vitreous humor and other segments of, or the whole eye, bones, skin, arteries, sperm, blood, other fluids (including breast milk), and any other portion of a human body.
3. Defines “tissue bank” as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Defines “transplantation” as the act or process of transferring tissue, including by ingestion, from a donor to the body of the donor or another human being.

This bill:

1. Defines “human milk tissue bank” as a tissue bank that provides a participating mother with financial compensation for procuring human milk for the purpose of human consumption. Defines “participating mother” as a woman who provides her human milk to a human milk tissue bank in exchange for financial compensation.
2. Requires a human milk tissue bank to do all of the following:
   1. Comply with the Human Milk Banking Association of North America (HMBANA) guidelines for safely procuring, processing, storing, and distributing human milk until DPH adopts rules and regulations, as specified;
   2. Work with local, community-based or hospital-based lactation support groups to provide ongoing breastfeeding education and lactation support for a participating mother to ensure that her nursing children are adequately nourished by her human milk; and,
   3. Disclose to a prospective participating mother the purposes for which the procured milk is used.
3. Prohibits a human milk tissue bank from doing any of the following:
   1. Procuring human milk from a mother within her first 180 days postpartum;
   2. Using the term “donor” to describe a participating mother; and,
   3. Using the term “community benefit” to describe itself or its activities.
4. Requires DPH to adopt, on or before January 18, 2018, rules and regulations governing a human milk tissue bank substantially based upon HMBANA guidelines for safely procuring, processing, storing, and distributing human milk.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, human milk is the standard food for infants and young children—including premature and sick newborns. As research evidence continues to strengthen the case for exclusive human milk feeding for neonatal intensive care unit (NICU) infants, there has been increasing interest by pharmaceutical companies to develop human milk-based products. For the past 40 years, a non-profit, grassroots system of milk banking has supplied donated human milk to California maternity hospitals, with quality standards set by HMBANA. Despite addressing different feeding needs, for-profit companies and non-profit HMBANA members rely on the same source for their products: breastfeeding mothers. This competition for human milk has created ethically troubling situations. Safeguards established by this bill would allow for-profit companies to continue to operate, while protecting the non-profit milk banks’ supply of donor milk. These guidelines would also ensure the protection of breastfeeding mothers who have excess milk whether they choose to donate or sell it.
2. Breastfeeding and human milk benefits. According to the Center for Disease Control and Prevention’s Web site, one of the most highly effective preventive measures a mother can take to protect the health of her infant is to breastfeed. However, in the United States, although most mothers hope to breastfeed, and 79% of babies start out being breastfed, only 19% are exclusively breastfed six months later. Rates are significantly lower for African-American infants. An article in the Journal of Midwifery & Women’s Health lists the benefits of breastfeeding as decreased rates of sepsis, necrotizing enterocolitis, allergies, diabetes, obesity, and sudden infant death syndrome; increased tolerance for feedings; higher IQ; and improved general health.
3. Tissue bank licensure. To date, only four states (California, Texas, Maryland, and New York) formally regulate milk banks. The FDA states on its Web site that it has not been involved in establishing voluntary guidelines or state standards for milk banks. According to information provided by DPH to committee staff, DPH requires tissue bank applicants to provide policies and procedures for any process used to show that the applicant can ensure the safe collection, preservation, transportation, storage, and handling of the tissue, and to show that potential tissue donors have been tested or assessed for the transmission of disease through transplantation. Tissue banks are also required to explain how they are preventing the transmission of potential disease to the tissue recipient. For human breast milk, DPH prohibits donations for human ingestion from those who test reactive for agents of viral hepatitis (HBV and HCV), HTVL 1 & 2, HIV 1 & 2, or syphilis. Each licensed tissue bank follows its own policies and procedures, which DPH reviews prior to licensure. The quality of breast milk is not regulated except as it applies to microbial contamination. DPH currently licenses 95 tissue banks that include milk as a transplantable tissue: five that qualify potential tissue donors, collect, process, store, and distribute human milk; one that qualifies potential donors and collects unprocessed milk; two that collect and store unprocessed milk; and 87 hospital-based tissue banks that store processed human milk for patients’ prescription use. DPH does not distinguish between for-profit and non-profit human milk tissue banks when issuing licenses.
4. HMBANA. According to its Web site, HMBANA is a professional association for supporters of non-profit donor human milk banking and promotes the health of babies and mothers through the provision of safe pasteurized donor milk and support of breastfeeding. HMBANA is the only professional membership association for milk banks in Canada and the United States, and its guidelines are used globally as a standard for donor milk banking. Each HMBANA member milk bank is assessed yearly and required to provide evidence of adherence to the most recent edition of guidelines for the establishment and operation of a donor human milk bank. As part of the screening process, HMBANA guidelines exclude donors based on a number of clinical issues unique to human milk and infants, including: excessive alcohol consumption; use of marijuana, either medically or casually; use of tobacco or nicotine products, including casually and occasionally; those exposed to second-hand smoke; vegetarians and vegans who do not supplement their diets with Vitamin B12; and those who have used illegal drugs within the past 12 months.

According to HMBANA, the tissue processing fees charged by its member milk banks helps defray the cost of donor screening, milk processing, record keeping, donor recruitment, and dispensing of pasteurized milk. HMBANA states that it does not condone the practice of buying and selling human milk as a commodity (and the guidelines specifically prohibit remuneration for the donation of human milk), as introducing a profit motive could put the infant of the lactating mother at risk if she were to feel pressure to provide a certain volume of milk to a bank or a recipient, rather than feeding her own infant. HMBANA also states that a medical institution that is given incentives to provide a specific volume of milk may pressure mothers to become donors regardless of their own infants’ needs, and that the recipient is also potentially at risk if this perceived pressure motivates a donor to adulterate her milk to increase volume.

1. Rising concerns over the commercialization of human milk. Donor human milk bank experts and health care providers are concerned about the emerging business of financially compensating lactating women and selling their human-milk based products at a much higher price than donor human milk banks do, as well as creating competition for a scarce resource. A March 2015 article in The New York Times, “Breast Milk Becomes a Commodity, With Mothers Caught Up in Debate,” cites the differences in the amount of human milk produced in a year: Prolacta, a for-profit milk bank based in California, processed 2.4 million ounces of milk in 2014 and aimed to do 3.4 million in 2015. In comparison, all 18 non-profit banks nationwide that are HMBANA members dispensed 3.1 million ounces in 2013. HMBANA milk banks charge hospitals a few dollars an ounce to cover the cost of screening donors and pasteurizing the donated milk, which it says does not always cover its costs. Prolacta’s fortifier, which is used in combination with donor human milk, contains higher levels of protein, fats, and minerals and can cost about $180 an ounce. Prolacta launched the Tiny Treasures Milk Bank in 2014, which pays $1 per ounce either directly to the donor or to the charity of her choice. A typical baby consumes about $10,000 worth of Prolacta’s product over several weeks, and the cost is generally paid for by hospitals or insurers, not parents, according to The New York Times article.

Prolacta’s product is intended for extremely premature infants who weigh less than 2.76 pounds at birth. Prolacta states that the high cost is attributed to a higher screening level than HMBANA guidelines require, including lab tests to check for adulteration, ensuring DNA of the human milk matches the donor, and ensuring that the nutritional standard for the product is 20 calories per fluid ounce, in addition to many of the same screenings that HMBANA guidelines require. The founder of Prolacta left the company in 2009 and started another for-profit human milk bank, Medolac, based in Oregon, which produces sterilized donor human milk that does not require freezing or refrigeration. Other companies are also in the process of entering the human milk market.

1. Creating economic opportunities or exploitation? The article in The New York Times and another in Newsweek, “The Booming Market for Breast Milk,” quote lactating mothers who were able to make extra income from selling their breast milk. The women state that they produced extra milk and adequately fed their babies before donating. The Newsweek article states, “This free-market model [of selling human milk unregulated over the Internet at any price] has wedged itself between traditional non-profit human milk banks, neighborhood milk-swapping sites, and the newest bio-science companies looking to make a killing” from breast milk. A January 2015 article in The Detroit News, “Detroit groups question pitch for breast milk,” cites backlash that Medolac received when it planned to pay Detroit mothers for donated breast milk. A coalition of organizations accused Medolac of targeting low-income black women in a city with the highest infant mortality in the nation. Medolac’s initiative was included in the Clinton Global Initiative’s Web site as a co-op campaign to increase breastfeeding in urban areas while injecting nearly $6.57 million into urban communities by providing a source of income for breastfeeding women, as well as helping to raise breastfeeding rates for black infants, which are about 50% lower than for white infants at birth, age six months, and age 12 months, even when controlling for the family’s income or education level, according to The Detroit News. Non-profit human milk banks fear that paying women for donating breast milk can lead to women selling their breast milk while relying on formula to feed their babies. In a 2011 article published in Wired Magazine, Prolacta stated that it did not compensate donors for fear that financial incentive would attract women desperate enough to work the system. Prolacta’s CEO was quoted as saying, “We have to make it altruistic. Otherwise, there’ll be a picture of a mom on the front page of The New York Times saying, ‘I sold my milk for crack.’”
2. Prior legislation. SB 246 (Figueroa, Chapter 480, Statutes of 2006), required a hospital that collects, processes, stores, or distributes human milk collected from a mother exclusively for her own child to comply with HMBANA standards until or unless DPH approved alternative standards; exempted a hospital from the tissue bank licensure and regulation requirements for the purpose of collecting, processing, storing, or distributing human milk collected from a mother exclusively for her own child; exempted from any screening test requirement human milk collected from a mother exclusively for her own child; and specified that the provisions in this bill do not apply to any hospital that collects, processes, stores, or distributes milk from human milk banks or other outside sources.

SB 1785 (Figueroa, of 2006), was identical to SB 246. SB 1785 was held under submission in the Senate Appropriations Committee.

AB 532 (Lempert, Chapter 87, Statutes of 1999), made the procurement, processing, distribution, or use of human milk for the purpose of human consumption the rendition of a service rather than the sale of a product.

1. Support. Supporters, largely health providers and advocates, argue that California has significant disparities in pre-term birth rates, particularly among the low-income population, and ensuring they get the best possible nutrition is a health equity priority. Supporters state that they are seeing efforts to pay women to harvest mothers’ milk for use in synthesized human milk products, which are not widely used for all premature infants and meant for distribution largely outside of the region. Supporters state we must ensure that for-profit synthesized human milk products do not undermine the supply of evidence-based, pasteurized donor human milk for medically fragile infants in the state. The American Academy of Pediatrics argues that the commercialization of human milk is concerning to pediatricians because of its negative impact on low-income mothers and children, and has led to a decrease in donations to non-profit milk banks, which distribute milk regardless of ability to pay. Mother’s Milk Bank states that their community outreach increasingly finds that breastfeeding mothers are growing more confused by the different venues for milk collection, and by where and how their milk is ultimately used. Supporters state that this bill will require for-profit milk banks to accurately characterize their transactions with participating mothers.
2. Letters of concern. Prolacta expresses concerns with this bill. Prolacta states that they are the only company that makes clinically proven, high-value nutritional products derived from human milk, which have been proven to prevent debilitating illnesses unique to vulnerable babies. Prolacta states that the provisions in this bill would significantly inhibit their ability to successfully practice in their own state, and that prohibiting them from collecting milk from women before 180 days postpartum is illogical when they currently require a physician’s note every four months that states the mother is healthy and the baby is receiving all of the milk they require for their growth and development. Prolacta states that this safeguard prevents moms from donating their milk to the company instead of feeding their own children. Prolacta also states that they strongly advocate for the regulation of the human milk industry and are currently leading a federal effort to have the FDA adopt safety regulations. Prolacta states that this bill will not only stifle innovation and impede significant scientific research but will also jeopardize the milk supply for babies who need the company’s specialty lifesaving formulas. One individual writes with concerns that are substantially similar to Prolacta’s, including the prohibition of for-profits to use of the term “donor” when referencing participating mothers and the requirement to comply with HMBANA guidelines. The individual suggests amendments to this bill that would a) prohibit all milk banks from accepting milk from mothers within the 180-day postpartum period, unless a physician’s authorization is given; b) strike language that prohibits for-profits from referring to mothers as “donors” if they are compensated; and c) require all milk banks to test for nicotine and drugs of common abuse, and to test finished milk products for diseases and viruses.
3. Opposition. The National Coalition for Infant Health (NCfIH) argues that this bill will have unintended consequences of reducing the supply of human breast milk donations and production of a critical breastmilk supply for premature babies. NCfIH states that the prohibition to receive milk from mothers who are within the 180-day postpartum period is not evidence based, and that only for-profit companies manufacture the human milk-based supplements that help premature babies. Other opponents, comprised of four donating mothers, argue that their ability to donate extra milk, rather than throw it away, has enabled them to earn extra income to support their families while continuing to provide breast milk to their babies and help other babies in need. They argue that the organizations to which they donate have always made it clear to them how the donated milk is being used and have required rigorous screening before being able to donate.
4. Policy comments.
   1. The author of this bill states that the safeguards contained in this bill will allow for-profits to continue to operate. For-profits would be allowed to receive donated milk from women within the 180-day postpartum period, but they just would not be allowed to financially compensate donors during that time period. What is unclear is whether a for-profit would be required to obtain two separate licensure types: the current license for a “tissue bank” and an additional license for the new definition of “human milk tissue bank.” The author may wish to clarify this.
   2. It is unclear how DPH would track if a human milk tissue bank is providing compensation. The author may wish to clarify that DPH, when developing rules and regulations, is required to create a mechanism for tracking if a tissue bank is providing compensation.
   3. This bill requires DPH to develop rules and regulations governing a human milk tissue bank substantially based upon the HMBANA guidelines. While non-profit milk banks comply with HMBANA guidelines, nothing in current statute requires them to. The author may wish to amend language to require both for-profit and non-profit milk banks to comply with rules and regulations developed by DPH that, at a minimum, are substantially based upon HMBANA guidelines for safely procuring, processing, storing, and distributing human milk.

SUPPORT AND OPPOSITION:

Support: American Academy of Pediatrics

California Breastfeeding Coalition

California Center for Public Health Advocacy

California Conference of Local Health Department Nutritionists

California WIC Association

March of Dimes

Monterey County Nutrition Programs

Mother’s Milk Bank of San Jose

NEC Society

UC Davis Foods for Health Institute

Four individuals

Oppose: National Coalition for Infant Health

Four individuals

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