BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
SB 1316 (Wolk) - Tissue banks: human milk
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|Version: April 14, 2016 |Policy Vote: HEALTH 7 - 2 |
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|Urgency: No |Mandate: No |
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|Hearing Date: May 2, 2016 |Consultant: Brendan McCarthy |
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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
SB 1316 (Wolk) Page 1 of
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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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