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SB-975 Tissue bank licensing.(2009-2010)

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SB975:v98#DOCUMENT

Amended  IN  Senate  March 17, 2010

CALIFORNIA LEGISLATURE— 2009–2010 REGULAR SESSION

Senate Bill
No. 975

Introduced  by  Senator Price

February 08, 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   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.