BILL ANALYSIS �
AB 1893
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Date of Hearing: April 29, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1893 (Stone and Eggman) - As Amended: March 28, 2014
SUBJECT : Sharps waste.
SUMMARY : Requires the sale of an approved, labeled sharps
disposal container with the sale of medical sharps for
self-injection. Specifically, this bill :
1)Requires a sharps waste container, as approved by Department
of Public Health (DPH) container to be sold with medical
sharps.
2)Requires the container to include a label or insert that
provides directions for safe disposal of sharps waste, as
described, and a reference to the Department of Resources
Recycling and Recovery's (CalRecycle) Internet Website on
home-generated sharps waste disposals.
3)Allows manufacturers, sellers, or distributors to implement
voluntary take-back or mail-back programs.
4)Specifies that this bill does not preempt local ordinances
that establish mandatory take-back or collection systems for
waste disposal.
5)Encourages the Department of Industrial Relations (DIR),
Division of Workers' Compensation (DWC) to collect data
specific to puncture wounds caused by sharps waste in
non-health care occupations.
EXISTING STATE LAW :
1)Defines "home-generated sharps waste" to mean hypodermic
needles, pen needles, intravenous needles, lancets, and other
devices used to penetrate the skin for the delivery of
medications derived from a household, including a multifamily
residence or household.
2)Prohibits the disposal of home-generated sharps waste in solid
waste or recycling streams.
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3)Requires home-generated sharps waste be transported only in a
sharps container or other container approved by the applicable
enforcement agency and specifies disposal can only occur at
household hazardous waste facilities, at specified sharps
consolidation points, the facilities of medical waste
generators, or by the use of approved medical waste mail-back
containers.
4)Defines a sharps disposal container as a rigid
puncture-resistant container that, when sealed, is leak
resistant and cannot be reopened without great difficulty.
5)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
CalRecycle a plan that describes what actions, if any, the
manufacturer supports for the safe management of sharps waste.
6)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.
7)Authorizes local jurisdictions to include in their Household
Hazardous Waste Elements, a program for the safe management of
sharps waste.
8)Requires pharmacies that furnish nonprescription syringes to
provide written information or verbal counseling to consumers
at the time of furnishing or sale on, among other things, how
to safely dispose of sharps waste.
EXISTING FEDERAL LAW regulates sharps containers as medical
devices by the U.S. Food and Drug Administration (FDA).
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
intended to reduce cost to taxpayers, reduce needlestick
injuries, and help sharps users comply with current disposal
laws by ensuring that sharps users have proper disposal
containers, and are more informed of how to dispose of them.
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Even though it is illegal under current law to dispose of
home-generated sharps into regular trash or recycling, the
author states that most people who use sharps at home don't
know what do with their used sharps so they throw them in the
trash or flush them. As a result, thousands of pounds of
illegally disposed sharps enter the municipal waste stream
each year. It is the responsibility of individual sharps
consumers to comply with the law regarding containerization
and transportation of home-generated sharps to approved
locations.
The author states that in order to help consumers more easily
comply with current law, it would be useful and worthwhile to
provide consumers with a container and with the CalRecycle
Website address that so that they can easily look up where to
drop off their filled containers. Additionally, the author
states that this bill seeks to improve data collection to
ascertain the impact and risk of non-healthcare needles-tick
injuries by encouraging the DIR to collect data on the extent
of unintended needle stick injuries.
2)BACKGROUND . An estimated one million Californians inject
medications outside health care facilities using syringes,
lancets, pen needles, and other devices, collectively known as
"sharps". It is estimated that these generate 390 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 inject at home include
multiple sclerosis, infertility, migraines, allergies,
hemophilia, and medications for pets.
Once used, these sharps are regulated medical waste.
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, which prohibited the disposal of medical
sharps in California's landfills. Since 2008, it has been
illegal in California for sharps consumers to throw away their
home generated sharps in the general waste or recycling
stream. Home-generated sharps waste is required to be put
into an approved sharps container before being transported out
of the home to an approved drop-off location or via mail-back
program. CalRecycle maintains the Facility Information
Toolbox (FacIT) Website, which currently lists over 600
facilities where residents can take their home-generated
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sharps such as hospitals, pharmacies, or household hazardous
waste (HHW) facilities.
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. Current law 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 have reported great success.
Pharmaceutical manufacturers and distributors are required to
submit to CalRecycle a plan that describes what actions, if
any, the manufacturer supports for the safe management of
sharps waste.
3)CURRENT PRACTICE . In assessing barriers to proper disposal
performed by CalRecycle (then California Integrated Waste
Management Board) found that 14% of respondents reported
throwing sharps waste directly into trash, 34% put them in a
strong container and then into the trash, and 31% dispose of
them at a hospital, pharmacy HHW facility, mail-back program,
or other take-back method. According to the Coalition for
Safe Community Needle Disposal, 86% of self-injection sharps
are used for prescription purposes, while 14% are used by
illicit drug users.
4)LOCAL SOLUTIONS PATCHY . Many local governments provide some
level of service such as free sharps containers or free
mail-back kits for sharps. For example, the City of San Dimas
offers free or subsidized mail back sharps containers to
residents. The City of San Francisco has, since 1990,
operated the Safe Needle Disposal Program which is funded
through residential trash ratepayers. This program supplies
free sharps containers and free take-back through Walgreens
Pharmacy.
5)PUBLIC HEALTH RISKS . Municipal waste facilities report
finding thousands of pounds of illegally dumped sharps waste
in the waste stream each year. As regulated biohazard waste,
these needles post a significant health risk to the public due
to potential blood-borne pathogens, including HIV, Hepatitis
B, and Hepatitis C. Regardless of whether the sharp was
obtained for prescription or illegal drug use, any improperly
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disposed needle found in the waste stream must be considered
as potentially dangerous infectious material. Any needlestick
injury of unknown origin must be treated with full
prophylactic measures, which can range in cost from $400 to
$6000 per person.
6)NEED FOR DATA COLLECTION . In previous discussions of product
stewardship for sharps, some debate has focused on the lack of
data on needlestick injuries outside of the healthcare
workforce. A 2008 study titled, "Characteristics of persons
and jobs with needlestick injuries in a national data set,"
(JP Leigh, et.al) suggested that nationwide each year 25% or
roughly 150,000 to 200,000 needlesticks occurred outside the
health services industry for a cost of $38 million. Within
California, DWC collects data on all workers compensation
claims, but does not specifically separate or compile reports
on needlestick injuries in the waste collection work force.
This information would be useful have a more accurate
understanding of taxpayer costs incurred by illegally dumped
sharps.
7)SUPPORT . According to municipalities and solid waste
handlers, a large number of sharps are still being disposed of
in trash and recycling containers, which presents a dangerous
dilemma for thousands of workers every day. They argue
statewide efforts to hold producers responsible for sharps
waste management costs are needed. Republic Services states
that although their facilities have the capacity to deal with
illegally disposed sharps, the costs (which are ultimately
borne by ratepayers) are driven up by the unlawful disposal of
sharps. The City of Sunnyvale writes that needlestick
injuries drive up health costs and also that major equipment
downtime represents a high cost to the plant. When sharps are
found on the sorting line, the entire line needs to be shut
down to carefully find and remove them. UltiMed, Inc., a
syringe manufacturer, supports this bill because they are
concerned about accidental needle sticks caused by the
products they produce. UltiMed argues that the use of sharps
containers by self-injectors is a key component for every
known successful sharps disposal program.
8)OPPOSITION . Opponents, including many biotechnology firms,
argue this bill is premature as it burdens patients with a one
size fits all approach to sharps containment before the data
required in the bill is collected and analyzed. They also
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argue the approach in the bill is environmentally unsound as
it fails to recognize other effective sharps disposal
technologies currently on the market and patients should be
given choices of disposal technologies to best suit their
needs. Diabetes patient advocacy groups and pharmaceutical
manufacturers write that this bill has a potential to create
barriers to treatment. In addition, they argue people with
diabetes and other chronic conditions are the ones most likely
to remain responsible when it comes to disposing of sharps and
there is ample evidence that those who use IV drugs are much
less likely to dispose of syringes in the correct manner.
Novo Nordisk writes that this mandate could have devastating
health and fiscal consequences by interfering with a patient's
ability to purchase life-saving medication legally prescribed
to them by a physician by requiring patients to purchase a
product unrelated to their immediate health care needs. They
argue this bill unnecessarily punishes patients as there are
many free sharps disposal options available today. The
American Association of Diabetes Educators asserts that this
would place an unrealistic and less-than-feasible burden on
diabetic patients. They point out that a typical sharps
container can last well over a month, while a person may need
to buy needles, syringes, or lancets more often.
9)INFORMATIONAL HEARING . There will be a joint informational
hearing of the Assembly Health and Assembly Labor and
Employment Committees on May 13, 2014 entitled, "Worker Safety
and Sharps Waste in Non-Healthcare Occupations".
10)RELATED LEGISLATION .
a) AB 1743 (Ting) deletes the limit on the number of
syringes a pharmacist or physician can sell to an adult
without a prescription and deletes the sunset date of
January 1, 2015, that would end the statewide authorization
to sell syringes without a prescription. AB 1743 is in the
Senate Health Committee.
b) AB 2371 (Mullin) requires local governments to update
Household Hazardous Waste Management Element (HHWME) to
include consideration of the convenience of waste
collection. AB 2371 is pending in Assembly Local
Government Committee.
c) AB 403 (Stone and Eggman) of 2013 would have required
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manufacturers that sell medical sharps to establish a
product stewardship plan for home-generated medical waste.
AB 403 was held in the Assembly Appropriations Committee.
11)PREVIOUS LEGISLATION .
a) SB 419 (Simitian) of 2012 would have required
pharmaceutical manufacturers to provide their reports to
CalRecycle electronically and make them readily accessible
on their Websites. Governor Brown vetoed SB 419, stating
that the matter could be handled administratively.
b) SB 41 (Yee), Chapter 738, Statutes of 2011, among other
things, requires pharmacies to provide consumers with
prescribed options for consumer disposal of hypodermic
needles and syringes.
c) SB 486 (Simitian), Chapter 591, Statutes of 2009,
requires pharmaceutical manufacturers who sell medications
that are routinely injected at home to submit annual plans
to CalRecycle describing how they support and provide safe
sharps collection and disposal programs.
d) SB 1305 (Figueroa), Chapter 64, Statutes of 2006,
prohibits the disposal of home-generated sharps waste in
solid waste or recycling streams.
12)POLICY COMMENTS
a) Current language is unclear whether the sharps and the
container must be sold together or if they will be sold
separately as a condition of the sale of sharps. Is the
manufacturer or pharmacy being required to package the
sharp and disposal container together as one sale? This
ambiguity makes it unclear where the cost burden will fall.
Is the manufacturer, pharmacy, insurance company, or
patient the one paying for the sharps container? The
author may wish to clarify in the future who is responsible
for pairing the purchase of sharps and container.
b) There is wide variety among prescriptions and sharps
usage. Some diabetics test their blood sugar using a small
lancet daily, and will take months or years to fill a
sharps container. Some patients need to inject medication
with a syringe daily, and therefore will fill a sharps
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container more frequently. Mandating a container purchase
with every sale poses logistical questions the author may
wish to address in the future.
c) Although approved sharps containers are relatively
inexpensive ($3-$10 range for a small home container),
mandating the purchase could provide financial hardship for
some individuals. A few private insurance companies cover
sharps containers, but Medi-Cal and Medicare do not.
Additionally, it is likely that conditioning the sale of a
non-prescription item on the sale of a prescription is in
conflict with federal Medicaid law. Therefore, this bill
provisions may not be applicable to Medi-Cal beneficiaries.
The author may wish to address whether it is an undue
financial hardship to mandate the purchase of a
non-prescription item each time a patient makes a
prescription purchase.
d) Current law requires that sharps be disposed of in a
container approved by the local enforcement authority.
Some local take-back programs will accept sharps in rigid
containers other than FDA-approved models. This bill would
require consumers to purchase a sharps container that may
not be required by their take-back facility.
13)SUGGESTED AMENDMENTS . Technical amendment: Line 8 of the
bill specifies a container "that is approved by the
department". Currently, DPH does not approve sharps
containers. The FDA regulates sharps containers as medical
devices. Consider instead a container "that meets applicable
state and federal standards for collection and disposal of
medical sharps waste".
REGISTERED SUPPORT / OPPOSITION :
Support
California Product Stewardship Council (cosponsor)
California Refuse Recycling Council (cosponsor)
Alameda County Board of Supervisors
California Hepatitis C Task Force
California Labor Federation
California Resource Recovery Association
California State Association of Counties
California Teamster Public Affairs Council
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Californians Against Waste
City of Riverside Public Works Department
City of Roseville
City of Sacramento
City of Sunnyvale
City of Torrance
Clean Water Action
County of Sacramento
County of Santa Cruz
GreenWaste Recovery Inc.
Los Angeles County Solid Waste Management Committee/Integrated
Waste Management Task Force
Marin County Hazardous and Solid Waste Management JPA
Marin Sanitary Service
Mojave Desert and Mountain Recycling Authority
Napa Recycling & Waste Services
Republic Services
Russian River Watershed Association
Rural County Representatives of California
San Diego County Board of Supervisors
Solid Waste Association of North America
Sonoma County Waste Management Agency
UltiMed, Inc
Waste Management
Opposition
Advanced Medical Technology Association (unless amended)
American Association of Diabetes Educators
BayBio (unless amended)
BIOCOM (unless amended)
Biotechnology Industry Organization (unless amended)
California Healthcare Institute (unless amended)
Diabetes Hands Foundation
National Diabetes Volunteer Leadership Council (unless amended)
Novo Nordisk
Students with Diabetes
Taking Control of Your Diabetes
The diaTribe Foundation (unless amended)
The MAGIC Foundation (unless amended)
Six individuals
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Analysis Prepared by : Dharia McGrew / HEALTH / (916) 319-2097