BILL ANALYSIS �
AB 2356
Page 1
Date of Hearing: April 10, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 2356 (Skinner) - As Amended: March 29, 2012
SUBJECT : Tissue Donation.
SUMMARY : Exempts sperm donated by a sexually intimate partner
of the recipient for reproductive use from the requirement that
all tissues transferred into the body of another person be
screened and found nonreactive by laboratory tests for evidence
of infection with human immunodeficiency virus (HIV), agents of
viral hepatitis (HBV and HCV), syphilis, and human T
lymphotrophic virus (HTLV), as specified. Specifically, this
bill :
1)Exempts sperm donated by a sexually intimate partner of the
recipient for reproductive use from current requirements that
prohibits the transfer of any tissues into the body of another
person unless the donor has been screened and found
nonreactive of infection with HIV, HBV and HCV, syphilis, and
HTLV, as specified.
2)Defines sexually intimate partner of the recipient as a donor
to whose sperm the recipient has previously been exposed in a
nonmedical setting in an attempt to conceive.
3)Specifies numerous findings and declarations, including the
following:
a) Single women and same-sex female couples using a known
donor are unable to access the same fertility services as
women seeking to conceive using a male partner.
b) Federal Food and Drug Administration (FDA) regulations
require extensive testing, except when the donor is a
"sexually intimate partner." This term is not defined in
regulations, but its explicit purpose is to allow donation
without testing when the recipient has already been
exposed. Thus, this term can be interpreted to include
women who have already attempted at-home inseminations with
their donors' sperm because they have already been exposed
through these attempts.
4)States that until the term sexually intimate partner is
AB 2356
Page 2
explicitly defined by the FDA, it is the intent of the
Legislature to provide a clarification that, for the purposes
of tissues donated for reproductive use, a "sexually intimate
partner" includes any woman who has been exposed to the
donor's sperm outside of a medical setting.
5)Limits the definition of "sexually intimate partner" to this
bill and is not intended to have any effect on any provision
of the Family Code, including the definition of a "donor" for
purposes of determining legal parentage of a child.
6)Makes other technical, non-substantive, and conforming
changes.
EXISTING FEDERAL LAW:
1)Establishes the FDA, to among other functions, regulate and
inspect fertility centers. Requires fertility centers to
register with the FDA and comply with specified FDA fertility
center regulations.
2)Sets requirements for determining donor-eligibility, including
screening and testing, for donors of human cells, tissues, and
cellular-and tissue-based products (HCT/Ps). Specifies that
the screening and testing includes screening and testing for
specified communicable disease agents and diseases, including
HIV, HBV, HCV, and HTLV, as specified.
3)Defines HCT/Ps as articles containing or consisting of human
cells or tissues that are intended for implantation,
transplantation, infusion, or transfer into a human recipient.
States that examples of HCT/Ps include, but are not limited
to, bone, ligament, skin, dura mater, heart valve, cornea,
hematopoietic stem/progenitor cells derived from peripheral
and cord blood, manipulated autologous chondrocytes,
epithelial cells on a synthetic matrix, and semen or other
reproductive tissue.
4)Provides an exemption for donor-eligibility determination or
donor screening or testing for: a) cells and tissues for
autologous use; b) reproductive cells or tissue donated by a
sexually intimate partner of the recipient for reproductive
use; or, c) cryopreserved cells or tissue for reproductive
use, as specified.
5)Requires HCT/Ps to be quarantined until completion of the
donor-eligibility requirements. Defines quarantine as the
AB 2356
Page 3
storage or identification of an HCT/P, to prevent improper
release, in a physically separate area clearly identified for
such use, or through use of other procedures, such as
automated designation.
EXISTING STATE LAW :
1)Establishes the Department of Public Health (DPH) to, among
other functions, regulate the transfer of tissue into the body
of another person.
2)Prohibits the transfer of any tissue into the body of another
person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory
tests for evidence of infection with HIV, HBV and HCV virus,
and syphilis. Requires, for tissues that are rich in viable
leukocytes, the tissue to be tested for evidence of infection
with HTLV and found nonreactive.
3)Authorizes DPH to adopt regulations requiring additional
screening tests of donors of tissues when, in the opinion of
DPH, the action is necessary for the protection of the public,
donors, or recipients.
4)Exempts the following from the screening specified in 2)
above:
a) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of
that donor if the recipient is informed of the requirements
for testing donors, as specified, and signs a written
waiver.
b) A recipient of sperm may consent to therapeutic
insemination of sperm or use of sperm in other advanced
reproductive technologies even if the sperm donor is found
reactive for HBV, HCV, syphilis, HIV, or HTLV if the sperm
donor is the spouse of, partner of, or designated donor for
that recipient. Requires the physician providing
insemination or advanced reproductive technology services
to advise the donor and recipient of the potential medical
risks associated with receiving sperm from a reactive
donor. Requires the donor and the recipient to sign a
document affirming that each comprehends the potential
medical risks of using sperm from a reactive donor for the
proposed procedure and that each consents to it.
AB 2356
Page 4
c) Sperm whose donor has tested reactive for syphilis, HBV,
HIV, or HTLV may be used for the purposes of insemination
or advanced reproductive technology only after certain
requirements are met.
5)Requires DPH, no later than January 1, 2014, to adopt
regulations for facilities that perform sperm processing, as
specified. Specifies that until DPH adopts these regulations,
facilities that perform sperm processing must follow facility
and sperm processing guidelines for the reduction of viral
transmission developed by the American Society of Reproductive
Medicine.
6)Defines the following terms for purposes of tissue transfer:
a) Tissue means a human cell, group of cells, 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.
b) Tissue bank means a place, establishment, or institution
that collects, processes, stores, or distributes tissue for
transplantation into human beings.
c) Transplantation means the act or process of transferring
tissue, including by ingestion, from a donor to the body of
the donor or another human being.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . Equality California and the National
Center for Lesbian Rights are the sponsors of this measure.
According to the sponsors, this bill would provide same-sex
female couples or single women seeking to conceive using a
known sperm donor access to certain fertility services on the
same terms as different-sex couples. According to the author,
a woman who receives fertility services with a male partner is
able to use fresh sperm for insemination, greatly increasing
the likelihood of the woman conceiving. However, a woman who
receives fertility services with a known male donor can only
receive frozen sperm, reducing her chances of conceiving.
Women using a known donor for an at home insemination attempt
have already been exposed to the donor's semen, the same way
AB 2356
Page 5
women with a male partner have been exposed. However, due to
ambiguity in the law, physicians will only inseminate women
using a known donor with frozen sperm after the donor has been
screened for sexually transmitted diseases. Typically, for
these women sperm must be quarantined for six months and
re-screened before insemination. Not only is frozen sperm
less effective, but the six months waiting period can reduce
the chances of becoming pregnant for women over forty.
Insemination with frozen sperm is also significantly more
expensive than insemination with fresh sperm.
2)BACKGROUND .
a) Assisted Reproductive Technology (ART) . According to
the CDC, ART includes all fertility treatments in which
both eggs and sperm are handled. In general, ART
procedures involve surgically removing eggs from a woman's
ovaries, combining them with sperm in the laboratory, and
returning them to the woman's body or donating them to
another woman. CDC points out that of the approximately 62
million women of reproductive age in 2002, about 1.2
million, or 2%, had an infertility-related medical
appointment within the previous year, and 8% had an
infertility-related medical visit at some point in the
past. Infertility services include medical tests to
diagnose infertility, medical advice and treatments to help
a woman become pregnant, and services other than routine
prenatal care to prevent miscarriage. CDC also states that
the number of infants born after ART doubled in the United
States from 1996-2004, and in 2005, more than 134,000 ART
procedures were performed and approximately 52,000 infants
were born as a result of these procedures. According to a
CDC 2008 report, infants conceived with ART are two to four
times more likely to have certain types of birth defects
than children conceived naturally. CDC points out that ART
has been used in the United States since 1981 to help women
become pregnant, most commonly through the transfer of
fertilized human eggs into a woman's uterus (in vitro
fertilization or IVF). All fertility centers are required
to register with the FDA as an ART facility. The FDA is
also responsible for inspecting these facilities to ensure
compliance with FDA regulations.
b) Guidelines for Gamete and Embryo Donation: A Practice
Committee Report. Currently, there are two organizations
AB 2356
Page 6
to which physicians who practice reproductive medicine
generally belong. One is the American Society for
Reproductive Medicine (ASRM) and the other is the Society
for Reproductive Technology, an affiliate of ASRM.
According to the ASRM, sexually transmitted infections are
of major concern to reproductive specialists, most
importantly HIV types 1 and 2, HBV, and HCV viruses. These
pathogens, which may cause incurable, often fatal
infections have been transmitted through ART and
insemination procedures and can be transmitted from
infected mothers to the fetus or newborn. Other common
sexually transmissible viruses include HTLV, and several
members of the herpes virus family. The ASRM indicated
that sexually transmitted viruses can cause chronic
lifelong infections but recognizes that fertility services
cannot be withheld ethically from individuals with chronic
viral infections, if a treatment center has the resources
or facilities necessary to manage such patients. ASRM
currently provides guidelines on requirements for
treatment, facilities, sperm wash methods, and
virus-specific risk reduction strategies for all the
viruses.
In "2008 Guidelines for Gamete and Embryo Donation: A
Practice Committee Report" (Guidelines), the ASRM laid out
various recommendations or guidelines for potential sperm,
oocyte, and embryo donors. The Guidelines incorporate FDA
requirements and recent information about optimal screening
and testing for sexually transmitted infections, genetic
diseases, and psychological assessments. Generally,
physicians who are members of ASRM adhere to these
guidelines as the standard in the practice.
The Guidelines for sperm donation include recommendations on
the evaluation of the male and female partner, specifically
requiring HIV testing for both partners. Additionally, the
following are recommended in the screening and testing of
donors: examination of several samples before proceeding
with a more extensive evaluation; genetic evaluation,
extensive review of medical history, physical examinations,
including a physical examination before acceptance, and
every 6 months while remaining an active donor; laboratory
testing, including testing for HIV, HBV, HCV, syphilis, and
HTLV, consistent with FDA requirements. After donation,
anonymous donor specimens must be quarantined for a minimum
of 180 days and the donor must be retested after the
AB 2356
Page 7
required quarantine interval, and specimens may be released
only if the results of repeat testing are negative. The
Guidelines recommend that for directed (non-anonymous or
known donors), the same screening and testing must apply as
anonymous donors. The Guidelines also state that although
current FDA guidelines exempt directed donor specimens from
the quarantine requirements, as specified, the ASRM
recommends that directed donor specimens should be treated
in the same manner as anonymous donor specimens.
For sexually intimate couples, the Guidelines indicate that
although there is no FDA or legal requirement for viral
testing of sexually intimate partners undergoing fertility
treatment, such testing can help ensure that appropriate
precautions are taken to minimize risk of viral
transmission to partners and offspring.
The Guidelines for oocyte donation apply many of the
recommendations for sperm donation, including an evaluation
of the oocyte recipient and the partner of the oocyte
recipient, selection of donors, screening and testing of
oocyte donors, laboratory testing for specified
communicable diseases and agents, and management of
laboratory results.
ASRM also opines that the use of fresh semen can be justified
only for sexually intimate couples. It states that it is
possible for HIV and other infectious organisms to be
transmitted by fresh donor semen before the donor has
become seropositive (showing positive results), and the
potential for transmission of infections cannot be
eliminated. The ASRM also recommends that all frozen
specimens should be quarantined for a minimum of 180 days,
and the donor retested after the quarantine period.
c) Recent Case Involving Sperm Donation . Last year, the
FDA served an order to an individual in Fremont, California
to cease manufacturing or giving away his fresh semen to
women hoping to conceive. Several Bay Area newspapers,
including the San Francisco Chronicle and the San Jose
Mercury News, indicate that the FDA's Center for Biologics
Evaluation and Research inspected this individual's home
and found him in violation of numerous regulations,
including failing to properly protect himself against
communicable diseases. At the heart of the dispute is
whether this individual is a sexually intimate partner to
AB 2356
Page 8
women he donates his sperm to, and, therefore would exempt
him from regulatory requirements. The case is pending and
the individual faces potential financial penalties and jail
time. The FDA has not indicated whether it will clarify
the terms sexually intimate partner for purposes of this
case and future cases.
d) DPH regulations on facilities that perform sperm
processing . Current law requires DPH, no later than
January 1, 2014, to adopt regulations regulating facilities
that perform sperm processing, that prescribe standards for
the handling and storage of sperm samples of carriers of
HIV, HTLV, and any other virus as deemed appropriate by
DPH. It also states that DPH may propose to adopt, as
initial regulations, the recommendations made within the
"Guidelines for Reducing Risk of Viral Transmission During
Fertility Treatment," as developed by the ASRM. Until DPH
adopts these regulations, facilities that perform sperm
processing must follow these guidelines. According to
DPH, it plans to adopt the recommendations made within the
Guidelines as regulations with an expected publication in
2013. DPH also points out that the regulations would also
recommend sexually transmitted diseases testing for couples
at risk for infection and all women receiving treatments
from sperm donors.
3)SUPPORT . Supporters such as API Equality, Colage, Rainbow
Flag Health Services and Sperm Bank, and Tres Lunas Midwifery
all state that this bill would provide lesbian, bisexual, and
transgender people and single women seeking to conceive using
a known sperm donor access to certain fertility services on
the same terms as different-sex couples. They state that a
disparity arises between different-sex couples and other women
using known donors when they may need to seek fertility
services in a medical setting after failed attempts to
conceive at home. Whereas different-sex couples are permitted
to use fresh sperm to inseminate when using fertility
services, all other women must typically have their donor's
sperm frozen and quarantined for up to six months to allow for
repeated donor screening for sexually transmitted diseases.
Yet, women who have attempted to inseminate at home with a
designated donor are exposed to exactly the same risk of
disease transmission as women who have intercourse with male
partners to conceive. They state that the process of freezing
and quarantining sperm significantly reduces the chances of
achieving pregnancy and often means that conception is not
AB 2356
Page 9
possible without much more expensive procedures. Supporters
claim that all donors will continue to be tested for sexually
transmitted diseases initially, and this bill only addresses
requirements for repeated testing.
4)SUPPORT IF AMENDED . The California Medical Association (CMA)
has taken a support if amended position on this bill. CMA
states that many of its members remain uncertain how this
bill, if enacted, would correlate with existing FDA
regulations, which many physicians use as guidance when
performing fertility treatment. CMA is requesting that the
author consider amendments that would help protect physicians
from liability for their actions, including the recipient
receiving informed consent and an assumption of the risk.
5)OPPOSE UNLESS AMENDED . The American College of Obstetricians
and Gynecologists (ACOG) has taken an oppose unless amended
position on this bill. ACOG states that this bill is
attempting to change a definition of federal law in state law
relative to how the FDA would determine "sexually intimate"
partners for purposes of a known sperm donor providing sperm
to a woman who has already been exposed to the sperm in a
nonmedical setting. ACOG states that attempting to create a
definition at the state level of a national regulation could
invite confusion and chaos when a physician is unclear which
law or guideline should be used. Additionally, ACOG points
out that there may be some medical professionals willing to
take the risk of proceeding to use a known sperm donor to
whose sperm the woman has already been exposed in a nonmedical
setting. As such, if it is clear that a physician is immune
from liability for their actions, including allowing a
recipient to receive informed consent and an assumption of
risk, ACOG will not oppose this measure.
6)OPPOSITION . The California Right to Life Committee, Inc
states that this measure is not good public health policy and
sets a precedent for other exemptions in the future which
might be deleterious to women.
7)PREVIOUS LEGISLATION .
a) AB 1487 (Hill), Chapter 444, Statutes of 2010, among
other provisions, required testing for HTLV infections and
extends until January 1, 2014, the date for DPH to adopt
regulations for facilities that perform sperm processing.
AB 2356
Page 10
b) AB 1397 (Hill) of 2009 was nearly identical to the
provisions of AB 1487. AB 1397 was vetoed by the Governor
with the message: "While I support the intent of this
bill, some provisions inappropriately restrict the
administrative and regulatory authority of the Department
of Public Health for adopting or modifying the American
Society for Reproductive Medicine guidelines. I would be
willing to reconsider a bill that does not infringe on the
Department's regulatory authority."
c) SB 1184 (Kuehl), Chapter 347, Statutes of 2008, requires
each clinical laboratory to report all CD4+ T-Cell test
results to the local health officer within seven days of
the completion of the test. If a CD4+ T-Cell test result
is related to a case of HIV infection, the local health
officer would be required to report the case of HIV
infection or AIDS to the department within 45 days of
receipt of the laboratory report. Also requires a
physician providing insemination or advanced reproductive
technologies to, among other things, verify, and document
in the recipient's medical record, that the donor of sperm
who tests reactive for HIV or HTLV-1 is under the care of a
physician managing the HIV or HTLV-1 to minimize the risk
of transmission during the course of insemination or
advanced reproductive technology services.
d) SB 443 (Migden), Chapter 207, Statutes of 2007,
authorizes the use of sperm whose donor has tested reactive
for HIV or HTLV-1 for the purposes of insemination or
advanced reproductive technology only after the donor's
sperm has been effectively processed to minimize the
infectiousness of the sperm for that specific donation, and
where informed and mutual consent has occurred. Requires
DPH to adopt regulations by January 1, 2010, regulating
facilities that perform sperm processing pursuant to
specified provisions. Requires a physician providing
insemination or advanced reproductive technologies to
provide prophylactic treatments, including, antiretroviral
treatments, to the recipient to reduce the risk of
acquiring infection during and subsequent to insemination,
and to perform appropriate follow-up testing of the
recipient for HIV or HTLV-1 following the insemination or
other advanced reproductive technology.
e) AB 441 (Mazzoni/Richter), Chapter 511, Statutes of 1997,
AB 2356
Page 11
creates an exception to the prohibition of the transfer of
any tissues, as defined, into the body of another person
unless the donor of the tissues has been screened and found
nonreactive for evidence of infection with HIV, HBV, HCV,
HTLV, and syphilis. AB 441 also authorizes a recipient of
sperm to consent to therapeutic insemination of sperm or
other reproductive use of sperm even if the donor of the
sperm is found reactive for hepatitis B, hepatitis C, or
syphilis, if the sperm donor is the spouse, partner, or
designated donor, of the recipient and if certain other
conditions are met.
f) AB 525 (Speier), Chapter 659, Statutes of 1993,
authorized the recipient of sperm, from a donor known to
the recipient, to waive a second or repeat screening of
that donor if the recipient is informed of the requirements
for testing donors under California law and signs a written
waiver. Revised the definition of "transplantation" to
include the transfer of tissue from a donor to the body of
another human being.
8)COMMENTS .
a) Definition of "Sexually Intimate Partner ." Since
federal regulations have not explicitly defined what
constitutes "sexually intimate partner" for purposes of
exemption from reproductive tissue screening and testing,
it is unclear if including a definition in state law is
sufficient to guarantee the exemption. In light of the
pending case, described above, against the Fremont
individual where the definition of sexually intimate
partner is at the center of the dispute, will the FDA be
bound by this measure's definition and no longer take any
enforcement action against individuals or establishments in
the same situation? Additionally, will this measure give
consumers and establishments the impression that because
California has defined the terms sexually intimate partner,
that the FDA will no longer take enforcement action against
them for deemed violations?
b) Physician Immunity from Liability . As indicated above,
CMA and ACOG are proposing to support or not oppose this
measure if physicians are immune from liability for their
actions, including allowing a recipient receiving informed
consent and an assumption of risk. Although the details of
this proposed immunity are not defined at this time,
AB 2356
Page 12
because the FDA has regulatory authority over fertility
centers, which are mostly physician-owned and operated,
will a state-granted immunity protect physicians from
enforcement actions by the FDA?
REGISTERED SUPPORT / OPPOSITION :
Support
Betty T. Yee, Member, First District, State Board of
Equalization
American Civil Liberties Union
API Equality - Northern California
Asian & Pacific Islander Wellness Center
American Federation of State, County and Municipal Employees,
AFL-CIO
At Home Fertility
California Fertility Partners
Colage
GroundSpark
Our Family Coalition
Rainbow Flag Health Services and Sperm Bank
Somos Familia
Tres Lunas Midwifery
Several individuals
Opposition
California Right to Life Committee, Inc
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097