BILL NUMBER: AB 995	AMENDED
	BILL TEXT

	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  Care Services  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 by the department
 . This bill would also allow the department to impose on
licensed  and unlicensed  tissue banks, as an
alternative to suspension or revocation of a tissue bank's license, a
civil administrative penalty of  up to  $100 per
 infraction or immediate jeopardy, up to a maximum amount of
$3,050   day of noncompliance per violation not to
exceed an aggregate of $3,000  per day  of noncompliance
 .
   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 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. 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  up to 
one hundred dollars ($100) per  infraction or  
day of noncompliance per violation, including an  immediate
jeopardy,  up to a maximum amount of three thousand fifty
dollars ($3,050) per day of noncompliance.   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 and may also be imposed upon nonlicensed
tissue banks.   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.