BILL ANALYSIS �
Senate Appropriations Committee Fiscal Summary
Senator Christine Kehoe, Chair
SB 1267 (Padilla) - Genetic Information Privacy Act.
Amended: May 1, 2012 Policy Vote: Judiciary 3-2
Urgency: No Mandate: Yes
Hearing Date: May 14, 2012 Consultant: Jolie Onodera
This bill meets the criteria for referral to the Suspense File.
Bill Summary: SB 1267 would enact the Genetic Information
Privacy Act, which would prohibit any person, as defined, from
obtaining, analyzing, retaining, or disclosing genetic
information without the written authorization of the individual
to whom the information pertains, as specified. This bill would
specify the information that must be included in the
authorization. This bill would also establish civil and criminal
penalties for violations of the bill's provisions, as specified.
This bill would provide for the exemption of certain individuals
from the aforementioned prohibitions and penalties.
Fiscal Impact:
Increased central research administrative personnel
costs of $285,000 to $594,000 (General Fund) per year to
the University of California (UC) system. Increased
operational costs and potential loss of research funding of
an unknown, but potentially significant amount in the
millions of dollars annually.
Annual costs of $350,000 to $400,000 (General Fund) to
the California Correctional Health Care Services for
increased administrative workload.
Potential annual costs in the range of $25,000 to
$75,000 (General Fund) to the Judicial Branch for an
increase of 50 limited or unlimited civil filings per year
for violations of the Act.
Potential costs of $25,000 (General Fund) to the
Judicial Branch for 50 new misdemeanor fillings per year
for violations of the Act.
Non-reimbursable local costs for enforcement offset to a
degree by fine revenue.
Background: Existing federal and state laws offer various
protections for genetic testing. However, in recent years,
SB 1267 (Padilla)
Page 1
concerns have been raised over direct-to-consumer (DTC) genetic
testing that allows consumers to submit genetic samples in order
to test for genetic disorders, identify ancestral links, or
participate in research studies.
A 2010 report by the U.S. Government Accountability Office (GAO)
entitled "Direct-to-Consumer Genetic Tests: Misleading Test
Results are Further Complicated by Deceptive Marketing and Other
Questionable Practices," identified 10 egregious examples of
deceptive marketing, including claims made by four companies
that a consumer's DNA could be used to create personalized
supplements to cure diseases. Further, GAO's fictitious
consumers received test results that were misleading and of
little or no practical use. For example, GAO's donors often
received disease risk predictions that varied across the four
companies, indicating that identical DNA samples yielded
contradictory results.
Proposed Law: This bill would establish the Genetic Information
Privacy Act, as follows:
Provides that genetic information is protected by the right of
privacy pursuant to Article I of Section I of the California
Constitution.
Prohibits any person from obtaining, analyzing, retaining, or
disclosing without the written authorization of the individual
to whom the information pertains.
Provides that a separate written authorization is required for
each separate disclosure of an individual's genetic
information.
Sets forth both civil and criminal penalties, as follows:
o Any person who negligently violates these provisions
shall be assessed a civil penalty not to exceed $1,000
plus court costs, as determined by the court, to be paid
to the individual.
o Any person who willfully violates these provisions
shall be assessed a civil penalty of $1,000 to $5,000
plus court costs, as determined by the court, to be paid
to the individual.
o Any person who willfully or negligently violates
these provisions and the violation results in economic,
bodily, or emotional harm to the individual, is guilty of
a misdemeanor punishable by a fine not to exceed $10,000.
o In addition to any assessed civil penalties, a
person who commits a violation of these provisions shall
SB 1267 (Padilla)
Page 2
be liable to the person for all actual damages, including
damages for economic, bodily, or emotional harm which is
proximately caused by the act.
o Provides that each violation is a separate and
actionable offense.
Requires the written authorization to satisfy all of the
following requirements:
o Written in plain language and be in a typeface no
smaller than 14-point type.
o Shall be dated and signed by the individual to whom
the information pertains or a person authorized to act on
behalf of the individual.
o Shall be a separate document, not attached to any
other document, and shall not be more than one page.
o Prescribes the specific written form to obtain the
authorization of the individual.
Requires any person who obtains, analyzes, retains, or
discloses the genetic information to comply with the
following:
o The person may not use the genetic information for
any purpose other than the purpose authorized by the
individual to whom the information pertains.
o Once the purpose authorized has been fulfilled, the
individual's genetic information and DNA sample shall be
destroyed.
o The person shall permit an individual to limit
access to his or her genetic information to a certain
person(s).
o The person shall permit an individual to revoke an
authorization signed at any time.
o The person shall provide an individual who has
signed an authorization with a copy of that authorization
upon request.
Provides that genetic information may be obtained, analyzed,
retained, or disclosed without authorization for the following
cases provided the information is only for the specified
purposes indicated, and any other use would be subject to the
authorization:
o A law enforcement official in the execution of his
or her official duties consistent with existing law.
o A hospital, laboratory, or physician carrying out
court-ordered tests for genetic information.
o A licensed health care professional, as defined.
o A coroner or medical examiner in the execution of
SB 1267 (Padilla)
Page 3
his or her official duties consistent with existing law.
o Any screening of newborn infants required by state
or federal law.
Disaggregated and anonymized data collected before the
enactment of the act may be obtained, analyzed, retained, or
disclosed without the authorization provided in this bill.
Disaggregated and anonymized data may be obtained, analyzed,
retained, or disclosed if written authorization is obtained
and the data is used for a purpose authorized by the
individual to whom the information pertains.
Prior Legislation: SB 559 (Padilla) Chapter 261/2011 prohibits
discrimination under the Unruh Civil Rights Act and Fair
Employment and Housing Act on the basis of genetic information.
SB 482 (Padilla) 2009 would have specifically provided that
companies providing direct-to-consumer genetic testing are not
clinical laboratories and are therefore not subject to
requirements for those entities. This bill was referred but not
heard in the Senate Committee on Judiciary.
Staff Comments: The University of California (UC) conservatively
estimates the provisions of this bill could increase central
research administrative personnel costs by $285,000 to $594,000
(General Fund) per year. These costs would result from the
increased staffing workload associated with the collection,
storage, and monitoring of compliance with the separate
authorization forms the UC would be required to obtain from any
research participant whose genetic information would be
obtained, analyzed, retained, or disclosed.
Representatives from UC also indicated concern that the
provisions of this bill could place UC at a competitive
disadvantage for public and private research grants. UC received
$5.4 billion in research awards from public and private funding
sources in Fiscal Year 2011. To the extent the provisions of
this bill result in even a small percentage reduction in these
awards, a loss of millions of dollars in research funding
brought into the state could result.
This bill could also significantly increase UC hospital patient
recordkeeping costs. To the extent this bill would affect UC's
records of patient family health history on every patient,
increased costs to UC operations could be significant, likely in
SB 1267 (Padilla)
Page 4
the hundreds of thousands of dollars annually.
The California Correctional Health Care Services (CCHCS) has
also indicated the provisions of this bill will result in
increased administrative workload associated with reviewing
inmate medical records prior to disclosure to outside providers
for the purpose of diagnosis and treatment of inmates, and for
obtaining separate written authorizations from the inmates for
each disclosure.
This bill establishes both civil and criminal penalties for
violations of the written authorization requirements of the
bill. The Judicial Council indicates it cannot precisely
determine the level of increased workload and costs to the
courts resulting from the establishment of these new crimes but
provides a potential range of costs.
Based on information from the GAO report, genetic tests range
from $299 to $999 per test. As a result, it is assumed that most
filings would be limited civil filings (claims under $25,000),
however, to the extent the bill provides for the payment of
damages for economic, bodily, or emotional harm, in addition to
the fine, the number of unlimited civil filings could also
increase. The cost for 50 new limited or unlimited civil filings
would increase costs to the courts in the range of $25,000 to
$75,000 (General Fund) per year. Assuming 50 new misdemeanor
filings per year (which equates to less than one filing per
county per year), would increase court costs by approximately
$25,000 (General Fund) per year.