BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 486|
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UNFINISHED BUSINESS
Bill No: SB 486
Author: Simitian (D)
Amended: 8/31/09
Vote: 21
SENATE ENV. QUALITY COMMITTEE : 7-0, 4/27/09
AYES: Simitian, Runner, Ashburn, Corbett, Hancock,
Lowenthal, Pavley
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SENATE FLOOR : 32-4, 5/14/09
AYES: Aanestad, Alquist, Ashburn, Calderon, Cogdill,
Corbett, Correa, Cox, DeSaulnier, Ducheny, Dutton,
Florez, Hancock, Harman, Huff, Kehoe, Leno, Liu,
Lowenthal, Maldonado, Negrete McLeod, Padilla, Pavley,
Romero, Runner, Simitian, Steinberg, Strickland, Wiggins,
Wolk, Wright, Yee
NOES: Benoit, Denham, Hollingsworth, Walters
NO VOTE RECORDED: Cedillo, Oropeza, Wyland, Vacancy
ASSEMBLY FLOOR : 46-22, 9/2/09 - See last page for vote
SUBJECT : Medical waste: sharps waste
SOURCE : Author
DIGEST : This bill requires a pharmaceutical manufacturer
that sells or distributes a medication that is
self-injected at home through the use of a hypodermic
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needle, pen needle, intravenous needle, or any other
similar devices to submit to the California Integrated
Waste Management Board, or its successor agency, a plan
that describes how the manufacturer supports the safe
collection and destruction of home-generated sharps waste.
Assembly Amendments make clarifying changes.
ANALYSIS :
Existing Law
1.Under the Health and Safety Code:
A. Defines "Home-generated sharps waste" to mean
hypodermic needles, pen needles, intravenous needles,
lancets, and other devices that are used to penetrate
the skin for the delivery of medications derived from
a household, including a multifamily residence or
household. (Health and Safety Code Section 117671.)
B. Prohibits the disposal of home-generated sharps
waste in the solid waste or recycling streams.
(Health and Safety Code Section 118286.)
C. Permits hospitals and other health facilities,
pharmacies, fire stations, and existing city and
county household hazardous waste programs to accept
home-generated sharps for disposal. (Health and
Safety Code Section 118147.)
2.Under the Integrated Waste Management Act:
A. Authorizes local jurisdictions to include in the
Household Hazardous Waste Elements, a program for the
safe management of sharps waste.
B. Requires the California Integrated Waste
Management Board (CIWMB) to develop model plans for
the management of waste drugs generated from
household.
This bill:
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1.Requires a pharmaceutical manufacturer, on or before July
1, 2010, that sells or distributes a medication in
California that is self-injected at home through the use
of a hypodermic needle, pen needle, intravenous needle,
or any other similar device to submit to the CIWMB a plan
that describes how the manufacturer supports the safe
collection and destruction of the home-generated waste
devices.
2.Requires that the report be submitted annually after the
initial date of July 1, 2010.
3.Requires the plan to include, at a minimum, a description
of the actions taken by the manufacturer to do all of the
following:
A. Provide for the safe collection and destruction of
the home-generated sharps waste generated by its
customers.
B. Educate consumers about safe management and
collection opportunities.
C. Support efforts by retailers, pharmaceutical
distributors, manufacturers of injection devices and
other partners including local governments, health
care organizations, public health officers, solid
waste service providers and other groups with
interest in protecting public health and safety
through the safe collection and destruction of
home-generated sharps waste.
4.Requires the manufacturer to post and maintain a copy of
the plan on its Internet web site.
5.Requires the CIWMB to post and maintain copies of the
plans submitted by the manufacturers on its Internet web
site.
Status of the Issue . While disposal of sharps is illegal,
there is no statutory program in place to require the
management of sharps by manufacturers, pharmaceutical
companies, pharmacies or others. The Health and Safety
Code allows for a streamlined oversight structure for those
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that do wish to provide a safe disposal for sharps to their
customers or the general public, but there is no mandate
for them to do so. Some pharmacies and health care
providers have developed programs as a way to assist their
customers and have reported great success. Many local
governments also provide some level of service. However,
these programs do not compose an effective-statewide
network to handle the number of sharps generated. They are
also often funded through local governments, and with the
budget issues, some are in danger of postponing service.
Extended Producer Responsibility (EPR)/Product Stewardship .
These policy ideas are often used interchangeably but the
common goal is to develop new policies on product design
and management. The CIWMB defines EPR as a strategy to
place a shared responsibility for end-of-life product
management on the producers, and all entities involved in
the product chain, instead of the general public; while
encouraging product design changes that minimize a negative
impact on human health and the environment at every state
of the product's lifecycle. The CIWMB developed an EPR
Framework in January 2008. The Framework is intended to
guide proposals to seek statutory changes that would
provide the CIWMB with the authority to identify and bring
products into an EPR program.
Groups such as the California Product Stewardship Council,
who are working with a wide variety of stakeholders on the
policy platform that producers have the primary
responsibility to establish, fund, and manage end-of-life
systems for their products with government setting the
performance goals and ensuring accountability and
transparency.
Many local government have joined this effort to shift
California's product waste management system from one
focused on government funded and ratepayer financed waste
diversion to one that relies on producer responsibility in
order to reduce public costs and drive improvements in
product design that promote environmental sustainability.
It is hoped that the EPR approach would at some point not
have to be a mandated program, but that product
manufacturers would adopt these polices in a voluntary
manner.
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FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Assembly Appropriations Committee, this
bill will result in annual costs of approximately $150,000
to the CIWMB to receive reports from manufacturers and to
post them on its web site.
SUPPORT : (Verified 5/5/09)
Alameda Alliance of Health
Alameda County Board of Supervisors
Alameda County Waste Management Authority
Amylin Pharmaceuticals
Arthritis Foundation, California Chapters
Berkeley United Pharmacy
California Hepatitis C Task Force
California Labor Federation
California Narcotics Officers' Association
California NeuroAlliance
California Nurses Association
California Primary Care Association
California Product Stewardship Council
California Retailers Association
California Sharps Coalition
California State Association of Counties
California Teamsters Public Affairs Council
Californians Against Waste
City Council of Oakland
Central Contra Costa Solid Waste Authority
Genentech
HIV Education and Prevention Project of Alameda County
Los Angeles County Solid Waste Management Committee
National Multiple Sclerosis Society
National Multiple Sclerosis Society, California Action
Network
National Multiple Sclerosis Society, Northern California
Chapter
National Multiple Sclerosis Society, Pacific South Chapter
Republic Services, Inc.
San Diego County Board of Supervisors
San Francisco Recycling and Disposal
Santa Clara County Board of Supervisors
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Service Employees International Union
Sierra Club California
UCLA School of Nursing
UNITE HERE!
Waste Management, Inc.
OPPOSITION : (Verified 9/3/09)
Amylin Pharmaceuticals, Inc.
Pharmaceutical Research and Manufacturers of America
Sanofi-Aventis US
ARGUMENTS IN SUPPORT : According to the author's office,
with the prohibition of disposal of sharps in the waste
stream and no convenient, cost effect method of management
identified, it is time to take steps to find a solution of
the problem. The first step to that is to identify what
the companies that manufacture the medicines that are
dispensed through a "sharp" are doing to help their
customers address the disposal ban issue.
Nationally, there are more than three billion sharps
generated annually. Approximately three percent of the
U.S. population self-injects; this means approximately
eight percent of homes in the U.S. include people who
self-inject some type of medication. The need to keep the
growing number of sharps out of the municipal waste stream
has gained serious attention. California was one of the
fore-runners in that policy shift with the passage of SB
1305 (Figueroa), Chapter 64, Statutes of 2006. Although
illegal, most of these used needles still end up in
household trash and pose a significant risk of injury
and/or infection to children, custodial workers and solid
waste employees.
An estimated one million Californians inject medications
outside traditional health care facilities, which generate
approximately 389 million sharps each year. The numbers of
patients using injectable medications will continue to grow
because it is an effective delivery method. The most
common home use of sharps is to manage diabetes. Other
reasons to home-inject include multiple sclerosis,
infertility, migraines, allergies, hemophilia and
medications for pets.
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The author's office believes that this bill represents a
first step toward developing an EPR approach to the
management of sharps, and provides a way to determine what
the pharmaceutical industry is doing to assist with the
effort to manage sharps.
ARGUMENTS IN OPPOSITION : The opposition argues that
"[t]he issues around safe disposal and the duty to comply
with the state law rest with the consumer. It is their
affirmative duty t dispose of the hypodermic needles,
prefilled syringes and pens property both to comply with
the law and to ensure the safety of their families,
neighbors and community." The opposition contends that
"the reporting requirements of the bill [should be]
broadened to include all sharps, not just a specified
number of limited devices, and apply equal reporting
requirements on the waste industry in an attempt to gain a
full understanding of the depth of illegally disposed
sharps in the waste stream." The opposition contends that
this "only seems reasonable if the state wishes to
understand the disposal methods being offered and the
problems with the improper disposal of sharps."
ASSEMBLY FLOOR :
AYES: Adams, Arambula, Beall, Bill Berryhill, Block,
Blumenfield, Brownley, Caballero, Charles Calderon,
Carter, Chesbro, Cook, Coto, Davis, De La Torre, De Leon,
Eng, Evans, Feuer, Fong, Furutani, Galgiani, Hayashi,
Hernandez, Huber, Huffman, Jones, Krekorian, Lieu, Bonnie
Lowenthal, Mendoza, Miller, Monning, Nava, John A. Perez,
V. Manuel Perez, Ruskin, Salas, Saldana, Skinner,
Swanson, Torlakson, Torres, Torrico, Yamada, Bass
NOES: Anderson, Tom Berryhill, Blakeslee, Conway, DeVore,
Duvall, Fletcher, Fuller, Gaines, Garrick, Gilmore,
Hagman, Harkey, Hill, Knight, Logue, Niello, Nielsen,
Silva, Smyth, Audra Strickland, Tran
NO VOTE RECORDED: Ammiano, Buchanan, Emmerson, Fuentes,
Hall, Jeffries, Ma, Nestande, Portantino, Solorio,
Villines, Vacancy
TSM:cm 9/3/09 Senate Floor Analyses
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SUPPORT/OPPOSITION: SEE ABOVE
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