BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1316
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|AUTHOR: |Wolk |
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|VERSION: |February 19, 2016 |
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|HEARING DATE: |April 6, 2016 | | |
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|CONSULTANT: |Reyes Diaz |
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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:
a) Licensed blood banks;
b) 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;
c) 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;
d) The collection, processing, storage, or
distribution of fetal tissue or tissue derived from a
human embryo or fetus;
e) The collection, processing, storage or
distribution by an organ procurement organization;
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f) The storage of prepackaged, freeze-dried bone
by a general acute care hospital;
g) 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,
h) 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:
a) Comply with the Human Milk Banking Association
of North America (HMBANA) guidelines for safely
SB 1316 (Wolk) Page 3 of ?
procuring, processing, storing, and distributing human
milk until DPH adopts rules and regulations, as
specified;
b) 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,
c) 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:
a) Procuring human milk from a mother within her
first 180 days postpartum;
b) Using the term "donor" to describe a
participating mother; and,
c) 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
SB 1316 (Wolk) Page 4 of ?
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
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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.
5)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
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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.
6)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
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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.'"
7)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
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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.
8)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.
9)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
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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.
10)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.
11)Policy comments.
a) 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
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wish to clarify this.
b) 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.
c) 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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