BILL ANALYSIS
------------------------------------------------------------
|SENATE RULES COMMITTEE | AB 52|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
THIRD READING
Bill No: AB 52
Author: Portantino (D)
Amended: 8/30/10 in Senate
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE : 5-3, 8/11/10
AYES: Alquist, Strickland, Leno, Negrete McLeod, Pavley
NOES: Aanestad, Cedillo, Romero
NO VOTE RECORDED: Vacancy
ASSEMBLY FLOOR : 68-8, 6/2/09 - See last page for vote
SUBJECT : Umbilical Cord Blood Collection Program
SOURCE : American College of Obstetricians and
Gynecologists,
IX/CA
DIGEST : This bill requests the University of California
(UC) to develop a plan to establish and administer the
Umbilical Cord Blood Collection Program (UCBCP) for the
purpose of collecting units of umbilical cord blood for
public use, as specified, increases the fee for birth
certificate copies by $2 to provide funds to implement the
UCBCP, and requires the UC to implement the plan,
contingent on an unspecified amount of funds being
available in the UCBCP Fund (Fund).
ANALYSIS : Existing federal law establishes a national
umbilical cord blood network and authorizes funding to
CONTINUED
AB 52
Page
2
collect and maintain human cord blood stem cells for the
treatment of patients and for research and also includes
directives for umbilical cord blood donation, education and
advocacy.
Existing state law:
1. Requires the Department of Public Health (DPH), until
January 1, 2015, to establish the UCBCP for the purpose
of increasing the amount of umbilical cord blood that is
donated in the state and added to the national umbilical
cord blood inventory.
2. Authorizes the UCBCP, to the extent private or public
funds are identified and secured for these purposes, to
identify and provide funds for grants or contracts with
qualified blood banks that are licensed and accredited
to collect and store umbilical cord blood for public
transplantation purposes.
3. Permits DPH to implement any additional standards for
blood banks, to collect and store umbilical cord blood,
through the adoption of regulations.
4. Establishes the Umbilical Cord Blood Collection Program
Fund (Fund), consisting of federal, state, and private
funds made available for purposes of the program.
5. Requires DPH, contingent upon private funding, to
conduct the Umbilical Cord Blood Community Awareness
Campaign to provide awareness, assistance, and
information regarding umbilical cord blood banking
options using brochures, television, print media, radio,
the Internet, outdoor advertising, and other media;
establish an Internet Web site with specified
information; and, undertake public education activities
related to umbilical cord blood donation to targeted
populations, as appropriate.
6. Requires DPH to provide umbilical cord blood samples to
the Birth Defect Monitoring Program, for storage and
research, as specified.
This bill:
CONTINUED
AB 52
Page
3
1. Requests UC, by July 1, 2011, to develop a plan to
establish and administer the UCBCP for the purpose of
collecting units of umbilical cord blood for public use
as specified, and deletes DPH's responsibility for
administering the program.
2. Expresses intent that UC submit the plan to the health
and fiscal committees of the Legislature.
3. Adds $2 to the current fee for certified copies of birth
certificates and requires the additional $2 to be paid
into the Fund for support of the UCBCP.
4. Provides that funds shall be appropriated for the UCBCP
to the extent the plan and implementation of the program
are consistent with the goals and intent of the bill.
5. Provides that moneys appropriated for the UCBCP shall be
available for encumbrance or expenditure for three
fiscal years following the appropriation of the funds.
6. Defines public use of umbilical cord blood as blood
units from genetically diverse donors that will be owned
by the UC.
7. Requires the inventory to be accessible by the National
Registry and other qualified registries and transplant
centers, as specified, for transplantation and research
uses.
8. Permits UC, for the purpose of implementing cord blood
collection goals of the program, to contract with one or
more entities that are in compliance with federal
guidelines and regulations.
9. Permits UC to use a competitive process to select
entities to administer the collection and research
objectives of the program, if the UC chooses not to
undertake these activities itself.
10.Requires entities selected to bank, bank cord blood
units to have, at minimum, an investigational new drug
exemption or a biological license from the Federal Drug
CONTINUED
AB 52
Page
4
Administration.
11.Establishes qualifications for an entity to receive
umbilical cord blood units for research, and requires a
medical provider or research facility to comply with all
applicable state and federal laws with respect to
personally identifiable information contained in the
inventory.
12.Subjects these entities to existing penalties for
violations.
13.Expresses the intent of the Legislature that UC limit
fees for access to cord blood units to the reasonable
and actual costs of storage, handling, and providing
units, as well as for related services, as specified.
14.Expresses the intent of the Legislature that UC:
A. Develop a strategy to increase voluntary
participation by hospitals in the collection and
storage of umbilical cord blood and identify
funding sources to offset the financial impact on
hospitals.
B. Consider a medical contingency response program
to prepare for and respond effectively to
biological, chemical, or radiological attacks,
accidents, and other public health emergencies
where victims potentially benefit from treatment.
C. Explore the feasibility of operating the program
as a self-funding program, including the potential
of charging users a reimbursement fee.
15.Permits UC to deny further access to any confidential
information maintained by the UC to any person who
violates its policies to maintain confidentiality of
information, and subject them to a civil penalty of up
to $1,000.
16.Sunsets the UCBCP and the $2 additional birth
certificate fee on January 1, 2018.
CONTINUED
AB 52
Page
5
Background
Umbilical cord blood . Umbilical cord blood refers to the
blood that remains in the umbilical cord and placenta
following birth. It is one of three sources of cells used
in transplants, along with bone marrow and peripheral blood
stem cells. According to a July 2002 fact sheet by the
March of Dimes, blood retrieved from the umbilical cord is
a rich source of stem cells that can be used to treat
various genetic disorders that affect the blood and immune
system, leukemia and certain cancers, some inherited
disorders of body chemistry, and other life-threatening
diseases. Stem cells from umbilical cord blood offer some
advantages over those retrieved from bone marrow.
Umbilical cord blood stem cells are much easier to obtain;
a broader range of recipients may benefit from them; and, a
potentially fatal complication called graft versus host
disease, in which donor cells can attack the recipient's
tissues, appears to occur less frequently with umbilical
cord blood than with bone marrow. Stem cells from
umbilical cord blood have proven in many instances to be
superior to traditional bone marrow transplants because
they require a less perfect match than bone marrow
transplants, thus making it more likely to find a suitable
donor, especially among minority populations.
The National Marrow Donor Program (NMDP) estimates that on
any given day, more than 6,000 patients around the world
are searching the NMDPs registry for a matching bone marrow
or umbilical cord blood donor. The NMDP states that since
umbilical cord blood is stored, ready to use and does not
require a perfect donor match, it is especially useful for
patients who need a transplant quickly, patients who have
difficulty finding a matched bone marrow donor, and
patients from racially diverse communities who often have
uncommon tissue types. Patients are more likely to match
someone who shares their racial and ethnic heritage. The
NMDP reports that, in 2008, 36 percent of the 90,000 cord
blood units in its registry went to patients from racially
or ethnically diverse communities and the need for cord
blood donations from these populations remain high.
Umbilical cord blood banking for personal use . In January
2007, the American Academy of Pediatrics (AAP) issued an
CONTINUED
AB 52
Page
6
updated policy statement on umbilical cord blood banking
for potential future transplantation. The AAP estimates
that the chances of a child needing his or her own cord
blood stem cells in the future range from 1 in 1,000 to 1
in 200,000. In the event that a child requires a stem cell
transplant, the AAP indicates that it is unlikely that the
child's own cord blood would be the desired source of stem
cells, because the cells would reintroduce the disease into
the child's body. In these cases, a sibling donor is ideal
as a donor. AAP states that storing a child's cord blood
is only worthwhile when there is a sibling with a disease
who can be treated by a transplant. Under these
circumstances, there is a one-in-four chance that the new
baby will be a match for his or her sibling. Given that
the probability of using one's own cord blood in the first
20 years of life is very small, the AAP does not favor
storage of cord blood for personal use and instead
encourages families to donate their newborn's cord blood to
public banks, if accessible in their area, for use by other
individuals in need.
Umbilical cord blood banks (Banks) . Public and private
Banks provide for the collection and storage of cord blood.
Public banks promote both related and unrelated donation,
similar to the current collection of whole blood units in
the U.S., for transplantation or research purposes.
Private Banks store umbilical cord blood from an individual
for subsequent use by the same individual or his or her
family members, should the need arise. Private Banks
typically charge between $1,000 and $2,000 in collection
fees and between $50 and $150 annually for storage. Public
Banks do not charge for cord blood that is donated for
public use. The American Association of Blood Banks (AABB)
and the Foundation for the Accreditation of Cellular
Therapy (FACT) provide voluntary accreditation of cord
blood banks and establish standards governing all aspects
of operation, including collection, processing, and
transplantation. According to their respective Web sites,
27 facilities nationwide are currently accredited by the
AABB and 17 currently have FACT accreditation.
California banks and collection facilities . According to
the NMDP, there are currently two participating public
banks in California, StemCyte International Cord Blood
CONTINUED
AB 52
Page
7
Center in West Covina, which provides both public and
private banking services, and Children's Hospital of Orange
County Cord Blood Bank. Another public bank in San Diego,
the Ashley Ross Cord Blood Program, participates in the
NMDP, but it is not actively collecting cord blood at this
time due to funding shortages. According to the nonprofit
Parent's Guide to Cord Blood Foundation, there are
additionally four private banks operating in the state:
CordBancUSA in Monterey, Cord Blood America and FamilyCord,
both based in Los Angeles, and Cord Blood Registry in San
Bruno.
The Laboratory Field Services Branch of DPH regulates
umbilical cord blood banks in California. An umbilical
cord blood bank that operates within California, accepts
collections from California, or releases cord blood units
to California, is required to obtain a biologics license
from DPH, which must be renewed annually. DPH requires
applicants to comply with specific requirements relating to
personnel, relevant business permits, standard operating
procedures, informed consent, laboratory testing,
equipment, safety manuals and emergency plans, supplier and
vendor information, quality control, and records.
Generally, DPH requires facilities to be inspected prior to
approving a license but will accept accreditation by AABB
in lieu of an inspection in limited cases.
According to the NMDP, because cord blood donation is only
beginning to grow in prevalence, not all hospitals
currently collect cord blood donations. The NMDP's
registry is the largest listing of cord blood in the world
(over 190,000 units), and includes banks outside of the
U.S. In the U.S., NMDP has 14 cord blood banks with more
than 46,000 cord blood units. In 2005, more than 250 cord
blood units were provided for transplant, 29 percent of
which went to racial and ethnic minorities. Forty percent
of the cord blood units listed by NMDP are from minority
racial and ethnic donors.
Children's Hospital Oakland Research Institute operates a
Sibling Donor Cord Blood Program for families who have a
child with a transplant-treatable condition, and who are
expecting a baby who is a full sibling of the affected
child. UCLA operated a cord blood bank which originated
CONTINUED
AB 52
Page
8
with National Institutes of Health grants, but could not
continue due to a lack of funding. The Ashley Ross Cord
Blood Bank in San Diego has collected 2,300 cord blood
units but is now releasing only one unit per month and is
not accepting new donors as a result of lack of funding.
One public and private bank in Florida, Cryobanks
International, will accept and process donated cord blood
units from anywhere in the United States.
Marrow and umbilical cord blood matching . According to
NMDP, marrow and cord blood transplants require matching
certain tissue traits of the donor and patient. Because
these traits are inherited, a patient's most likely match
is someone of the same heritage. American Indian, Alaska
Native, Asian, African-American, Latino, Native Hawaiian
and other Pacific Islander, and multiple-race patients face
a greater challenge in finding matched donors or cord blood
than white patients. NMDP and other organizations, such as
the National Cord Blood Program, are working to raise
awareness and recruit more cord blood donors in
underrepresented communities. In 2006, 26 percent of all
recipients from minority racial and ethnic groups received
cord blood transplants. Even with more than 50,000 cord
blood units listed under NMDP, some patients were unable to
find a match because of the rarity of their tissue traits.
National Cord Blood Inventory . The National Cord Blood
Inventory (NCBI), administered by the federal Health
Resources and Services Administration (HRSA), was formed in
2006 to build a genetically and ethnically diverse
inventory of 150,000 new units of high-quality umbilical
cord blood for transplantation and to make these cord blood
units available to physicians and patients for blood stem
cell transplants, and for research focusing on cord blood
stem cell biology. The NCBI works to achieve these goals
by providing funds to eight participating cord blood banks
nationwide. HRSA requested nearly $12 million in funding
for the NCBI in 2009 to add approximately 8,650 new units
of cord blood, and has collected a total of approximately
37,280 units collected to date.
In November 2006, HRSA awarded $12 million to six
institutions in California, Colorado, New York, North
Carolina, Texas, and Washington to begin collections for
CONTINUED
AB 52
Page
9
the NCBI. According to HRSA, NCBI will collect and
maintain high-quality cord blood units and make them
available for transplantation through the newly created
C.W. Bill Young Cell Transplantation Program. The NCBI
target is 150,000 new units of high-quality cord blood
collected from diverse populations, including those that
have historically been the least able to find a suitable
adult bone marrow donor match. The targeted demographics
for the initial cord blood collections are: 19 percent
African-American; 26 percent Latino; 6.5 percent Asian;
37.5 percent Caucasian; 10 percent multi-race; and, one
percent other underrepresented populations. HRSA undertook
a second cycle of competitive contracts to increase the
NCBI early in federal fiscal year 2007.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 9/14/10)
American College of Obstetricians and Gynecologists, IX/CA
(source)
African American Blood Drive and Bone Marrow Registry for
Sickle Cell Disease Awareness
American Federation of State, County, and Municipal
Employees
Association of Northern California Oncologists
Blood Centers of California
California Catholic Conference
California Communities United Institute
California Hospital Association
California Medical Association
California Nurses Association
California Nurse-Midwives Association
California State University, Long Beach, Nursing Students
City of Hope
City of Los Angeles
Commission on the Status of Women
Joanne Pang Foundation
Kaiser Permanente Medical Care Program
March of Dimes
Medical Oncology Association of Southern California
Planned Parenthood Affiliates of California, Inc.
Project RACE
CONTINUED
AB 52
Page
10
University of California
OPPOSITION : (Verified 9/14/10)
Child Abuse Prevention Center
ARGUMENTS IN SUPPORT : UC states that by promoting public
cord blood collection in one of the most ethnically diverse
states in the nation, this bill expands the number of
specific ethnic and multicultural cord blood units in the
national inventory and increase the chance of a suitable
match for Californians in need of a transplant.
Writing on a previous version of the bill, the American
College of Obstetricians and Gynecologists states that due
to the high cost of testing and storing umbilical cord
blood, it is reasonable to fund cord blood banking efforts
with public dollars in order to increase the inventory of
usable cord blood units.
ARGUMENTS IN OPPOSITION : The Child Abuse Prevention
Center (CAP Center) states that it opposes this bill unless
amended to remove the increase in birth certificate fees as
a funding source for the UCBCP. CAP Center states that
birth certificate fees have long been a source of funding
for child abuse prevention and intervention programs, and
that adding to the fees for other purposes may make it less
feasible to further raise them in the future for child
abuse prevention. CAP argues that, given that fees for
death certificates are lower than those for birth
certificates, an increase in death certificate fees would
be a more appropriate funding source for the bill.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Anderson, Arambula, Beall, Tom
Berryhill, Blakeslee, Blumenfield, Brownley, Buchanan,
Caballero, Charles Calderon, Carter, Chesbro, Cook, Coto,
Davis, De La Torre, De Leon, DeVore, Emmerson, Eng,
Evans, Feuer, Fletcher, Fong, Fuentes, Furutani,
Galgiani, Garrick, Gilmore, Hall, Harkey, Hayashi,
Hernandez, Hill, Huber, Huffman, Jeffries, Jones,
Krekorian, Lieu, Bonnie Lowenthal, Ma, Mendoza, Miller,
Monning, Nava, Nestande, Nielsen, John A. Perez, V.
Manuel Perez, Portantino, Price, Ruskin, Salas, Saldana,
CONTINUED
AB 52
Page
11
Skinner, Smyth, Solorio, Swanson, Torlakson, Torres,
Torrico, Tran, Villines, Yamada, Bass
NOES: Fuller, Gaines, Hagman, Knight, Logue, Niello, Silva,
Audra Strickland
NO VOTE RECORDED: Bill Berryhill, Block, Conway, Duvall
CTW:do 9/14/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED