BILL ANALYSIS
SB 486
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2009-2010 Regular Session
BILL NO: SB 486
AUTHOR: Simitian
AMENDED: April 2, 2009
FISCAL: Yes HEARING DATE: April 27, 2009
URGENCY: No CONSULTANT: Caroll
Mortensen
SUBJECT : HOME-GENERATED SHARPS WASTE
SUMMARY :
Existing law :
1) Under the Health and Safety Code (HSC):
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 (HSC 117671).
b) Prohibits the disposal of home-generated sharps waste
in the solid waste or recycling streams (HSC 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 (HSC 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 Integrated Waste Management Board to
develop model plans for the management of waste drugs
generated from households.
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This bill :
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 Integrated Waste
Management Board (IWMB) a plan that describes how the
manufacturer supports the safe collection and destruction
of the home-generated sharps waste, as defined in Section
117671 of the Health and Safety Code.
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 IWMB to post and maintain copies of the plans
submitted by the manufacturers on its Internet Web site.
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COMMENTS :
1) Purpose of Bill . According to the author, with the
prohibition of disposal of sharps in the waste stream and
no convenient, cost effective method of management
identified, it is time to take steps to find a solution to
the problem. The first step to that is to identify what
the companies that manufacturer the medicines that are
dispensed through a 'sharp' are doing to help their
customers address the disposal ban issue.
2) Background . Nationally, there are more than 3 billion
sharps generated annually. Approximately 3% of the U.S.
population self-injects; this means approximately 8% 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 (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 1 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 it to manage diabetes. Other
reasons to home-inject include multiple sclerosis,
infertility, migraines, allergies, hemophilia and
medications for pets.
3) 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 HSC allows for a
streamlined oversight structure for those 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
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have reported great success. Many local governments also
provide some level of service. However, these programs do
not compose an effective state-wide network to handle
number of sharps generated. They are also often funded
through local governments, and with budget issues, some are
in danger of postponing service.
4) 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 IWMB 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 stage
of the product's lifecycle. The IWMB developed an EPR
Framework in January 2008. The Framework is intended to
guide proposals to seek statutory changes that would
provide the IWMB 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 governments 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 policies in a voluntary
manner.
SB 486 represents a first step toward developing an EPR
approach to the management of sharps. This bill provides a
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way to determine what the pharmaceutical industry is doing
to assist with the effort to manage sharps.
5) Related Legislation . Last session, AB 501 (Swanson)
required a pharmaceutical manufacturer, upon request of a
consumer who has been dispensed a prefilled injection
device for home administration (such as a prefilled
syringe), to arrange to provide the consumer with a sharps
container, a coupon for a sharps container or a toll-free
telephone number or web site on the device package that
directs the patient to a sharps container supplier. This
bill was vetoed by the Governor.
AB 283 (Chesbro) would establish an extended producer
responsibility framework that would be overseen and
implemented by the IWMB.
SOURCE : Senator Simitian
SUPPORT : Alameda County Board of Supervisors
Arthritis Foundation, California Chapters
California Labor Federation
California Product Stewardship Council
California Retailers Association
California Sharps Coalition
Californians Against Waste
National Multiple Sclerosis Society, Northern
California Chapter
National Multiple Sclerosis Society, California
Action Network
Sierra Club California
The Teamsters
UNITE HERE!
Waste Management, Inc.
OPPOSITION : None on file