Bill Text: CA SB975 | 2009-2010 | Regular Session | Amended
Bill Title: Tissue bank licensing. [Track Bill]
Status: 2010-04-14 - Set, second hearing. Hearing canceled at the request of author. [SB975 Detail]
Download: California-2009-SB975-Amended.html
BILL NUMBER: SB 975 AMENDED
BILL TEXT
AMENDED IN SENATE MARCH 17, 2010
INTRODUCED BY Senator Price
FEBRUARY 8, 2010
An act to amend Section 1635 of, to add Section 1643.3
to, and to repeal and add Section 1639.01 of, the Health and Safety
Code, relating to tissue banks.
LEGISLATIVE COUNSEL'S DIGEST
SB 975, as amended, Price. Tissue bank licensing.
Existing law requires the State Department of Public Health to
establish regulations, as specified, governing the operation and
maintenance of tissue banks licensed in California. Existing law
allows for the revocation or suspension of a tissue bank's license
for specified reasons. Violation of these provisions is a
misdemeanor.
This bill would require the collection, processing, storage, or
distribution of human tissue for use in California to comply with the
12th edition of Standards for Tissue Banking
in effect on January 1, 2011, as published by the American
Association of Tissue Banks, and would require the department to
evaluate future amendments of these standards to be
adopted determine which changes to adopt as
regulations , if approved by the department . This
bill would also allow the department to impose on licensed tissue
banks, as an alternative to suspension or revocation of a tissue bank'
s license, a civil administrative penalty of $100 per day of
noncompliance per violation not to exceed an aggregate of $3,000
per day .
Existing law defines "tissue" as any human cell, group of cells,
tissue, or organ, giving specific examples.
This bill would delete organ from this definition.
Because the bill would make changes to the definition of a crime,
it constitutes would impose a
state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1635 of the Health
and Safety Code is amended to read:
1635. (a) "Donor" is an individual, living or deceased, from whom
tissue is removed.
(b) "Person" is an individual, corporation, business trust, estate
trust, partnership, association, state or local government, or
subdivision or agency thereof, or any other legal entity.
(c) "Tissue" is any human cell, group of cells, tissue or
organ or tissue including the cornea, sclera,
or vitreous humor and other segments of, or the whole eye, bones,
skin, arteries, sperm, blood, other fluids, and any other portion of
a human body.
(d) "Tissue bank" is any place, establishment, or institution that
collects, processes, stores, or distributes tissue for
transplantation into human beings.
(e) "Transplantation" is the act or process of transferring
tissue, including by ingestion, from a donor to the body of the donor
or another human being.
(f) "State department" is the State Department of Public
Health Services .
SECTION 1. SEC. 2. Section 1639.01
of the Health and Safety Code is repealed.
SEC. 2. SEC. 3. Section 1639.01 is
added to the Health and Safety Code, to read:
1639.01. (a) Notwithstanding Section 1639, no person shall engage
in the collection, processing, storage, or distribution of human
tissue unless the tissue is collected, prepared, labeled, stored, and
distributed in accordance with the standards set forth in the
12th edition of Standards for Tissue Banking
in effect on January 1, 2011, as published by the American
Association of Tissue Banks and in effect on May 1, 2008
.
(b) Amendments to, or later editions of, the Standards for Tissue
Banking shall be adopted as regulations, upon approval of the
department, not later than 90 days after publication. This section
shall not be subject to the rulemaking requirements of Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code.
(b) Consistent with the purposes of this chapter, the department
shall evaluate amendments to the standards made in subsequent
editions by the American Association of Tissue Banks to determine
which changes to adopt as revised regulations. Proposed changes to
the regulations shall be posted on the department's Internet Web site
at least 45 days prior to their adoption. Public comment shall be
accepted by the department for at least 30 days after each posting.
If a member of the public requests a public hearing during the
30-day-posting period, the hearing shall be held prior to the
adoption of the proposed changes. Comments received shall be
considered prior to the posting of final changes. Adoption of changes
by the department pursuant to this section shall, notwithstanding
any other provision of law, not be subject to the rulemaking
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code and written
responses to public comments shall not be required.
SEC. 3. SEC. 4. Section 1643.3 is
added to the Health and Safety Code, to read:
1643.3. As an alternative to revocation or suspension of a
license issued under this chapter, the department may impose an
alternative civil administrative penalty of one hundred dollars
($100) per day of noncompliance per violation, including an immediate
jeopardy violation, except that the aggregate penalty per
day shall not exceed three thousand dollars ($3,000). This
penalty may be imposed only after notice and an opportunity to
respond in accordance with Section 100171.
SEC. 4. SEC. 5. No reimbursement is
required by this act pursuant to Section 6 of Article XIII B of the
California Constitution because the only costs that may be incurred
by a local agency or school district will be incurred because this
act creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction, within
the meaning of Section 17556 of the Government Code, or changes the
definition of a crime within the meaning of Section 6 of Article XIII
B of the California Constitution.
