BILL NUMBER: AB 995	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MAY 5, 2009
	AMENDED IN ASSEMBLY  APRIL 13, 2009

INTRODUCED BY   Assembly Member Block

                        FEBRUARY 27, 2009

   An act to amend Section 1639.01 of, and to add Section 1643.3 to,
the Health and Safety Code, relating to tissue banks.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 995, as amended, Block. 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 by licensed tissue banks and 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   evaluated
and considered for adoption  by the department  pursuant to
a specified process  . 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
amended 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. These shall
be the standards for all licensed tissue banks operating in
California or providing tissue to be used in California. 
   (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 by the
association. This section 
    (b)    Consistent with the purposes of this
chapter, the department shall evaluate updates to the standards made
by the American Association of Tissue Banks, including later
editions, to determine which changes to incorporate into the
regulations. Proposed changes to the standards 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 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
subdivision  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  and written responses to
public comments shall not be required  .
  SEC. 2.  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. 3.  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.