SB 1316, as amended, Wolk. Tissue banks: human milk.
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 wouldbegin delete 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 wouldend delete require abegin delete human milkend delete tissue bankbegin insert licensed by the department thatend insertbegin insert collects, processes, stores, or distributes human milkend insert to, among other things, work with lactation support groups to provide breastfeeding education and lactation support for abegin delete participatingend delete mother,begin insert from whom the tissue bank procures human milk,end insert
as provided. The bill would prohibitbegin delete a human milkend deletebegin insert theseend insert tissuebegin delete bankend deletebegin insert banksend insert from, among other things,begin delete procuring human milk fromend deletebegin insert providing payment toend insert a motherbegin insert for human milk the tissue bank procures from herend insert within her firstbegin delete 180end deletebegin insert
90end insert days postpartum. The bill would require the department to adopt, on or before January 1, 2018, rules and regulations governingbegin delete a human milkend deletebegin insert theseend insert tissuebegin delete bankend deletebegin insert banks that, at a minimum, areend insert 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 requirebegin delete a human milkend deletebegin insert theseend insert tissuebegin delete bankend deletebegin insert
banksend insert 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.begin insert The bill would provide that its provisions remain in effect only until January 1, 2022.end insert
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 1635 of the Health and Safety Code is
2amended to read:
(a) “Donor” means an individual, living or deceased,
4from whom tissue is removed.
5(b) “Person” means an individual, corporation, business trust,
6estate trust, partnership, association, state or local government, or
7subdivision or agency thereof, or any other legal entity.
8(c) “Tissue” means a human cell, group of cells, including the
9cornea, sclera, or vitreous humor and other segments of, or the
10whole eye, bones, skin, arteries, sperm, blood, other fluids, and
11any other portion of a human body.
12(d) “Tissue bank” means a place, establishment, or institution
13that
collects, processes, stores, or distributes tissue for
14transplantation into human beings.
15(e) “Transplantation” means the act or process of transferring
16tissue, including by ingestion, from a donor to the body of the
17donor or another human being.
18(f) “Department” means the State Department of Public Health.
P3 1(g) “Human milk tissue bank” means a tissue bank that provides
2a participating mother with financial compensation for procuring
3human milk for the purpose of human consumption.
4(h) “Participating mother” means a woman who provides her
5human milk to a human milk tissue bank in exchange for financial
6compensation.
Article 2.5 (commencing with Section 1642) is
9added to Chapter 4.1 of Division 2 of the Health and Safety Code,
10to read:
11
Abegin delete human milkend delete tissue bankbegin insert licensed by the department
15that collects, processes, stores, or distributes human milkend insert shall do
16all of the following:
17(a) Comply with the Human Milk Banking Association of North
18America guidelines for safely procuring, processing, storing, and
19distributing human milk, until the department adopts rules and
20regulations pursuant to Section 1642.4.
21(b) Work with local, community-based or hospital-based
22lactation support groups to provide ongoing
breastfeeding
23education and lactation support for abegin delete participatingend delete motherbegin insert from
24whom the tissue bank procures human milkend insert to ensure that her
25nursing children are adequately nourished by her human milk.
26(c) Disclose to abegin delete prospective participatingend delete motherbegin insert who is
27considering providing human milk to the tissue bankend insert the purposes
28for which the procured milk is used.
begin insert(a)end insertbegin insert end insert Abegin delete human milkend delete tissue bankbegin insert that collects, processes,
30stores, or distributes human milkend insert shall notbegin delete do any of the following:end delete
31begin delete(a)end deletebegin delete end deletebegin deleteProcureend deletebegin insert
provide payment to a mother forend insert human milk
32begin insert
procuredend insert frombegin delete a motherend deletebegin insert herend insert within her firstbegin delete 180end deletebegin insert 90end insert days
33postpartum.
34(b) Use the term “donor” to describe a participating mother.
end delete35(c) Use
end delete
36begin insert(b)end insertbegin insert end insertbegin insertA tissue bank that provides payment to a mother for human
37milk shall not useend insert the term “community benefit” to describe itself
38or its activities.
Notwithstanding Section 1639, the department shall
40adopt, on or before January 1, 2018, rules and regulations
P4 1governing abegin delete human milkend delete tissue bankbegin insert licensed by the department
2that collects, processes, stores, or distributes human milk that are,
3at a minimum,end insert substantially based upon the guidelines of the
4Human Milk Banking Association of North America for safely
5procuring, processing, storing, and distributing human milk.
A violation of this article does not constitute a
7misdemeanor punishable pursuant to Section 1641.
This article shall remain in effect only until January
91, 2022, and as of that date is repealed, unless a later enacted
10statute, that is enacted before January 1, 2022, deletes or extends
11that date.
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