BILL NUMBER: SB 975	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Price

                        FEBRUARY 8, 2010

   An act 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 introduced, 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 as published by the
American Association of Tissue Banks, and would require future
amendments of these standards to be adopted 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.
   Because the bill would make changes to the definition of a crime,
it constitutes 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 1639.01 of the Health and Safety Code is
repealed. 
   1639.01.  (a)  Notwithstanding Section 1639, the state department
shall adopt, on or before July 1, 2004, rules and regulations
governing licensed tissue banks engaged in the collection of human
musculoskeletal tissue, skin, and veins for transplantation in
humans. The regulations shall be substantially based upon the
criteria used by tissue bank trade associations in their respective
accreditation processes including, but not limited to, those of the
Eye Bank Association of America and the American Association of
Tissue Banks, and the scientific and technical data submitted by
individual tissue banks.
   (b)  Regulations adopted by the state department, pursuant to
subdivision (a), shall include minimum standards for all of the
following:
   (1)  Safe preservation, transportation, storage, and handling of
tissue acquired or used for transplantation.
   (2)  Testing of donors to determine compatibility when
appropriate.
   (3)  Testing or assessment of donors to prevent the spread of
disease through transplantation.
   (4)  Equipment.
   (5)  Methods.
   (6)  Personnel qualifications.
   (7)  Any other area concerning the operation or maintenance of a
tissue bank, not inconsistent with this chapter, as may be necessary
to carry out this chapter.
   (c)  On or before July 1, 2003, the department shall report to the
appropriate policy and fiscal committees of the Legislature
regarding the status of the proposed regulations. 
  SEC. 2.  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 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.
  SEC. 3.  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.  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.