BILL ANALYSIS �
AB 403
Page 1
Date of Hearing: April 16, 2013
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Luis Alejo, Chair
AB 403 (Stone) - As Amended: : April 8, 2013
As Proposed To Be Amended
SUBJECT : Home-generated medical sharps.
SUMMARY: Requires businesses that sell medial sharps to
establish a product stewardship plan for the end of life
management of home-generated medial sharps. Specifically, this
bill :
1) Establishes a new chapter in the Public Resources Code that
establishes a product stewardship program for home generated
hypodermic needles, syringes with needles attached, pen
needles, intravenous needles, or any other similar device
intended to self-inject medication at home.
2) Requires medical sharps producers to develop and implement a
program to collect transport and process home generated
medical sharps to be overseen by the Department of Resource
Recovery and Recycling (DRRR).
3) Requires, on or before April 1, 2015, medical sharps
producers or a stewardship organization designated by medical
sharps producers to submit a medical sharps stewardship plan
to DRRR. Specifies that the medical sharps stewardship plan
do all of the following:
a) Include the development and implementation of a
recovery program to reduce the generation and manage the
collection, transporting, processing, disposal of home
generated medical sharps;
b) Include provisions to meet collection rates of 25% and
20% to be met in 2016, and 2017 respectively. In
subsequent years, the plans will be required to meet
collection rates established by DRRR;
c) Include a funding mechanism to provide sufficient
funding to carry out the program;
d) Include education and outreach for consumers, the
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medical community, and retailers that would promote the
collection of home-generated sharps. Authorize this
information to include, but is not be limited to,
developing, and updating as necessary, educational and
other outreach materials aimed at all retailers and
distributors of home-generated sharps:
e) Provides for a home-generated sharps collection point
to be established in every county in the state, and that
the number of home-generated sharps collection points is
equal to at least one for every 25,000 people in the
state;
f) Requires that the funding mechanism be an amount that
cumulatively will adequately fund the program; and,
g) Requires that home-generated medical sharps producers,
and not consumers, are responsible for implementing the
home-generated sharps stewardship program.
4) Requires DRRR, within 90 days of receipt of a plan, to
determine if a plan is complete and to notify the submitter
of its determination. Requires, if it is not complete, the
submitter to revise and resubmit the plan within 90 days.
5) Allows medical sharp producers to join a stewardship
organization to jointly prepare and execute the medical
sharps stewardship plan. Provides that the stewardship
organization is a non-profit organization created by one or
more producers with at least four additional participants
from local government, medical sharps distributor, a waste
hauler, and consumer health organization.
6) Requires on or before July 1, 2017, and each year thereafter,
producer or product stewardship organization to submit a
report, to include:
a) The number of home-generated sharps collected by the
program in the previous calendar year and the collection
rate achieved in the previous calendar year;
b) The total sales data for sharps sold to distributors in
the state for the previous calendar year;
c) A report on the feedback from a stakeholders' meeting
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that shall be hosted by the producers subject to the plan
and made available by Webcast, prior to submittal of the
annual report;
d) Independently audited financial statements that detail
the financing method selected to sustainably fund the
implementation of the plan to achieve the minimum
collection rates described in the plan;
e) Examples and descriptions of educational materials
distributed to various stakeholders aimed at increasing
collection;
f) An evaluation of the effectiveness of the program,
specific to collection, public awareness, convenience, and
reduced improper disposal associated with both legal and
illegal drug use;
g) Any programmatic changes the producer or the
stewardship organization recommends based on new data
provided in the report; and
h) The location, hours, and contact information for all
home-generated sharps collection points established
pursuant to the plan.
7) Requires the producer or product stewardship organization to
submit to DRRR an annual administrative fee, to be
established by DRRR in an amount adequate to cover the full
costs of administering and enforcing this bill.
8) Establishes administrative civil penalties for any person who
violates the requirement of this act of $1,000 per violation
and $10,000 per violation if the violation is intentional,
knowing, or negligent.
9) Allows home-generated sharps waste be transported and managed
at a facility or other home-generated sharps collection point
operated pursuant to an approved home-generated sharps
stewardship plan.
EXISTING LAW
1)Prohibits the disposal of home-generated sharps waste in solid
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waste or recycling streams.
2)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
3)Requires pharmaceutical manufacturers that sell or distribute
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
DRRR a plan that describes what actions, if any, the
manufacturer supports for the safe management of sharps waste.
4)Requires that the safe management plan be submitted annually
after the initial date of July 1, 2010, and be posted on
DRRR's website as well as the manufacturer's website.
FISCAL EFFECT : Unknown
COMMENTS :
1)Need for the bill. According to California Product
Stewardship Council, the sponsors of AB 403, "Sharps in the
trash pose serious health risks to sanitation workers, water
treatment facility operators and the general public. In
addition to the immediate risk of a needle stick injury,
sharps put individuals at risk of acquiring blood borne
infectious diseases, such as hepatitis or HIV. Individuals
who suffer a needle stick injury must receive immediate
treatment and follow up care, including multiple lab tests and
medications.
While the state banned needles from trash disposal in 2008,
there is still no consistent, statewide program that is
sustainably funded or has high levels of effectiveness at
collecting the majority of sharps disposed each year in
California. This bill attempts to address the frustration
that people have trying to find affordable and convenient
sharps collection opportunities, which will in turn ensure
more needles do not end up improperly managed."
2)Medical sharps : An estimated one million Californians inject
medications outside traditional health care facilities, which
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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.
California was one of the first states to address the problems
of sharps with the passage of SB 1305 (Figueroa, Chapter 64,
Statutes of 2006) to prohibit the disposal of medical sharps
in California's landfills. 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.
3)Product stewardship : This is a waste management concept that
addresses the challenges of managing consumer products, like
household batteries, that pose costly and problematic issues
at end-of-life. According to the California Product
Stewardship Council, "Product stewardship involves consumers,
government agencies and product manufacturers sharing the
responsibility of reducing the impact of product waste on
public health, the environment, and the economy. Extended
Producer Responsibility (EPR) is 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.
This allows the costs of treatment and disposal to be
incorporated into the total cost of a product. It places
primary responsibility on the producer, or brand owner, who
makes design and marketing decisions. It also creates a
setting for markets to emerge that truly reflect the
environmental impacts of a product, and to which producers and
consumers respond."
REGISTERED SUPPORT / OPPOSITION :
Support
California Product Stewardship Council (sponsor)
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Blue Line Transfer, Inc.
Californians Against Waste
California Refuse Recycling Council/North/South
California State Association of Counties
City of Covina
City of Monterey
City of Roseville
City of Sacramento
City of San Diego
City of Sunnyvale
City of Torrance
Clean Water Action
Contra Costa Clean Waste Program
Sierra Club California
Contra Costa Clean Water Program
County of Santa Barbara
County of Sonoma
County of Yolo Waste Advisory Committee
GreenWaste Recovery Inc.
Los Angeles County Solid Waste Management Committee/ Integrated
Waste Management Task Force
Marin County Hazardous & Solid Waste Management Joint Powers
Authority
Monterey Regional Waste Management District
Napa Recycling & Waste Services
Republic Services
Rural County Representatives of California
Waste Management
Solid Waste Association of North America
Sonoma County Waste Management Agency
South San Francisco Scavenger Company, Inc.
Tamalpais Community Services District
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Ultimed Incorporated
Opposition
AdvaMed
BayBio
BIOCOM
California Healthcare Institute
PhRMA
Silicon Valley Leadership Group
TechNet
Analysis Prepared by : Bob Fredenburg / E.S. & T.M. / (916)
319-3965