BILL ANALYSIS Ó
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Wieckowski, Chair
2015 - 2016 Regular
Bill No: AB 45
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|Author: |Mullin |
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|Version: |1/21/2016 |Hearing |6/29/2016 |
| | |Date: | |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant:|Rachel Machi Wagoner |
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SUBJECT: Household hazardous waste.
ANALYSIS:
Existing federal law:
1) Under the Food, Drug, and Cosmetic Act, the Food and Drug
Administration (FDA) is authorized to oversee the safety of
food, drugs, and cosmetic products.
2) Under the Resource Conservation and Recovery Act (RCRA) of
1976, the management of solid and hazardous wastes is
regulated. In the context of pharmaceuticals, RCRA imposes
strict protocols for the collection of controlled substances.
3) The Secure and Responsible Drug Act specifies handling for
controlled substances, amendments made in 2014 ease the
restrictions on the collection of controlled substances.
Existing state law:
1) Under the California Hazardous Waste Control Act (HWCA), the
Department of Toxic Substances Control (DTSC) is authorized to
regulate hazardous materials and wastes in accordance with
RCRA and HWCA.
2) Under the California Integrated Waste Management Act:
a) Requires the Department of Resources Recycling and
Recovery (CalRecycle) to implement a statewide household
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hazardous waste substance information and collection
program.
b) Requires cities and counties to prepare, adopt, and
submit to CalRecycle a Household Hazardous Waste (HHW)
Element plan which identifies a program for the safe
collection, recycling, treatment, and disposal of hazardous
wastes that are generated by households within the
jurisdiction and provides a specific time frame for
achieving these objectives.
c) Requires CalRecycle and DTSC to jointly maintain a
database of all HHW collection events, facilities, and
programs within the state and make that information
available to the public upon request.
d) Requires CalRecycle to coordinate with DTSC to develop
and implement a public information program to provide
uniform and consistent information on the proper disposal
of hazardous substances found in and around homes, and to
assist the efforts of counties required to provide HHW
collection, recycling, and disposal programs.
e) Requires CalRecycle, upon appropriation by the
Legislature, to distribute grants to cities, counties, or
other local agencies with the responsibility for solid
waste management, and for local programs to help prevent
the disposal of hazardous wastes at disposal sites, which
include, but are not limited to, programs that expand or
implement HHW programs.
f) Authorizes local jurisdictions to include in their HHW
Elements a program for the safe management of sharps waste.
g) 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
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waste.
3) Under the Medical Waste Management Act (MWMA):
a) Requires the California Department of Public Health
(DPH) to regulate the management and handling of medical
waste.
b) Defines "pharmaceuticals" as a prescription or
over-the-counter human or veterinary drug.
"Pharmaceutical" does not include any pharmaceutical that
is regulated pursuant to either RCRA or the Radiation
Control Law and certain items, such as household waste, are
specifically excluded from the definition of medical waste.
c) Defines "medical waste" as including waste generated
from the consolidation of home-generated sharps.
d) Defines "pharmaceutical waste" as any pharmaceutical
that for any reason may no longer be sold or dispensed for
use as a drug and excludes from this definition those
pharmaceuticals that still have potential value to the
generator because they are being returned to a reverse
distributor for possible manufacturer credit.
e) Specifies that waste comprised only of pharmaceuticals
is biohazardous, and is considered "medical waste."
f) Defines "home-generated sharps waste" as 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.
g) Prohibits the disposal of home-generated sharps waste in
the trash or recycling containers, and requires that all
sharps waste be transported to a collection center in a
sharps container approved by the local enforcement agency.
h) Authorizes a registered medical waste generator to
accept and consolidate home-generated sharps waste with the
facility's medical waste stream under specified conditions.
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This bill:
1) Requires CalRecycle, in consultation with affected
industries, to adopt one or more model ordinances for a
comprehensive program for the collection of HHW for adoption
by a local jurisdiction that provides for the residential
collection and disposal of solid waste.
2) Local jurisdictions proposing to enact an ordinance to
govern the collection and diversion of HHW may adopt one of
the model ordinances after CalRecycle has posted the model
ordinances on its Internet Web site.
3) Expands the definition of HHW, for the purposes of this
section, to include sharps and pharmaceutical waste.
4) Requires CalRecycle to determine if an appropriate
nonprofit organization has been created and funded to make
grants to local governments for specified activities
relating to HHW programs.
5) Requires CalRecycle to consider a list of factors in
making the determination about the nonprofit organization.
6) The provisions of this bill will be repealed on January
1, 2019, if CalRecycle does not make the determination that
an appropriate nonprofit organization exists by December 31,
2018.
Background
Hazardous Waste.
1)Hazardous waste. Hazardous wastes are wastes with properties
that make them dangerous or potentially harmful to human health
or the environment. Hazardous wastes can be liquids, solids,
contained gases, or sludges. They can be by-products of
manufacturing processes or simply discarded commercial
products, like cleaning fluids or pesticides.
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2)Household Hazardous Waste (HHW). HHW is hazardous waste
commonly generated by households and includes such ubiquitous
items as batteries, pesticides, electronics, fluorescent lamps,
used oil, solvents, and house cleaners. Because these wastes
can pose a threat to health and safety and the environment. In
California, it is illegal to dispose of HHW in the trash, down
the drain, or by abandonment. HHW needs to be disposed of
through an HHW program.
Cities and counties are required to prepare, adopt, and submit
to CalRecycle, an HHW Management Element Plan, which identifies
a program for the safe collection, recycling, treatment, and
disposal of HHW. The Element Plan specifies how HHW generated
within the jurisdiction must be collected, treated, and
disposed. Each jurisdiction is required to prepare and
implement plans to reduce and safely collect, recycle, treat,
and dispose of HHW and provides a specific time frame for
achieving these objectives. While there are many different
approaches for the collection and management of HHW, all are
permitted by DTSC and most are operated by local jurisdictions.
Some private operators operate programs under contract with
local jurisdictions, including curbside and door-to-door
collection.
Pharmaceutical Waste.
3) Pharmaceuticals. According to the U.S. Centers for Medicare &
Medicaid Services, which publishes the National Health
Expenditure Projections 2012-2022, approximately $275.9
billion in prescription drugs were predicted to be prescribed
in the U.S. in 2014. However, 2014 expenditures were almost
$100 billion more than predicted according to the IMS
Institute for Healthcare Informatics. In an April 2015 study,
IMS stated that spending rose 13%, to a total of $374 billion.
After accounting for population growth and inflation, the
increase equaled 10%. A record 4.3 billion prescriptions were
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filled in 2014."These numbers do not reflect the purchase of
over-the-counter medications (OTCs).
a) Pharmaceutical contamination. There are two general
sources of pharmaceutical contamination in the environment:
human excretion and disposal. Estimates suggest that 3 to
50% of prescriptions become waste. United States hospitals
and long-term care facilities annually flush approximately
250 million pounds of unused pharmaceuticals down the
drain.
It is unknown (if not impossible) to determine how much
household pharmaceutical waste is flushed down the toilet.
However, anecdotally waste water treatment facilities note
that scraping pills off of water filtration systems is a
problem, in addition to the removal of pharmaceutical
agents from the water.
A study conducted by the United States Geological Survey
from 1999-2000 sampled 139 streams across 30 states and
found that 80% had measurable concentrations of
prescription and nonprescription drugs, steroids, and
reproductive hormones. Since the USGS released its report
in 2002, a number of studies have demonstrated the
low-level presence of pharmaceutical agents throughout the
environment and water supply.
Recent studies have found a variety of drugs in crops, such
as cholesterol medications, caffeine, and triclosan. In a
recent study, researchers found that the anticonvulsive
epilepsy drug, carbamazepine, can accumulate in crops
irrigated with recycled water and end up in the urine of
produce-eaters not on the drug. The researchers found that
while the amounts of the drug in a produce-eater's urine
were four orders of magnitude lower than what is seen in
the urine of patients purposefully taking the drug, there
is a possibility that trace amounts could still have health
effects in some people, such as those with a genetic
sensitivity to the drugs, pregnant women, children, and
those who eat a lot of produce, such as vegetarians.
With the growing practice of reclaiming wastewater for crop
irrigation, the produce contamination could become more
common and more potent.
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California, which grows a large portion of US produce,
currently uses reclaimed water for 6% of its irrigation
needs.
Additionally, as California's climate continues to change
and the state endures longer droughts, recycling and
reusing for groundwater and surface water recharge will
become more important and ensuring contamination prevention
and removal will be more crucial.
While the human effects of pharmaceutical agents in the
environment are not fully understood, harm to aquatic
organisms and ecosystems due to low levels of pharmaceutical
agents are clearly established.
Life-long exposure to ppb levels of an estrogen-based
synthetic hormone resulted in complete population failure in
fish due to the males failing to develop properly.
Mood altering drugs, such as Prozac, lead to changes in the
behavior of fish, making them easier prey.
The presence of persistent antibiotics, particularly
downstream from hospitals, has been partially credited for
the rise in resistant bacterial strains, which may also have
an indirect human impact.
b) Pharmaceutical Take-Back Programs.
i) DEA Take-back programs. The DEA's Take-Back events
are a significant piece of the White House's prescription
drug abuse prevention strategy released in 2011 by the
Office of National Drug Control Policy. "Drug Take-Back
Days," which are typically administered by law enforcement
in conjunction with county health offices or other local
government agencies, are one-time events that allow for
individuals to dispose of prescription or non-prescription
medications; following the collection, the pharmaceuticals
are taken to a safe disposal site.
The DEA's seventh National Take-Back Day in October 2013
collected 324 tons of expired and unwanted medications
across all 50 states. Since the inception of the National
Take-Back Day in 2010, the DEA has collected over 3.4
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million pounds of medicine from circulation.
ii) International take-back programs. In 1999, British
Columbia established the "Post-Consumer Pharmaceutical
Stewardship Association" (PCPSA) to establish a
pharmaceutical drug take-back program funded by
manufacturers. Manufacturers are required to pay for the
cost of collecting and managing the program; they are not
required to pay for cost of agency oversight. Currently,
over 100 companies participate in the PCPSA.
Within British Columbia, 95% of pharmacies choose to
participate in the program, accounting for over 1,000
collection sites. In 2009, the program diverted 112,000
pounds of medication from improper disposal or abuse for
an estimated cost of $400,000.
Australia established a national collection system in
place since 1998.
The European Union has required a national collection
system for unused or expired medicines since 2004.
iii) Take-back programs in the US. Locally run take-back
programs are prevalent throughout the US. A few states,
such as Michigan and Maine, have enacted laws to
facilitate the collection of pharmaceutical waste at
locations such as pharmacies (MI) or to create mail-back
programs for pharmaceutical waste (ME).
In light of the new statute in Colorado, the Colorado
Springs Airport has installed two marijuana take-back
bins, providing a location for travelers to safely and
legally dispose of their marijuana. Although recreational
marijuana is legal in Colorado, it is highly regulated at
the federal level and has a high diversion potential.
iv) SB 966 Model Guidelines in CA. Under the California
Integrated Waste Management Act (SB 966, Simitian/Kuehl,
Chapter 542, Statutes of 2007), CalRecycle created a model
collection program for household hazardous substances,
such as pharmaceuticals, and evaluated how local programs
implemented take-back programs. Programs that followed
the model guidelines were released from any liability
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associated with collecting home-generated pharmaceuticals.
The model program sunsetted on January 1, 2013.
CalRecycle's report to the Legislature on the pilot
project, Recommendations for Home-Generated Pharmaceutical
Collection Programs in California, recommends that proper
drug disposal mechanisms be put in place on a statewide
basis.
v) Local programs in CA. In 2010, CalRecycle identified
297 take-back programs in California. This includes
one-time take-back events, continuous take-back programs,
and mail-back programs. The majority of these programs
are funded and run by local governments, although San
Francisco has a program that is partially funded by PhRMA
and Genetech.
Recently, Alameda County passed a first in the nation Safe
Drug Disposal Ordinance that requires producers of covered
drugs to operate take-back programs, including the
creation, administration, promotion, and payment of the
program. The ordinance was challenged by Pharmaceutical
Research and Manufacturers of America, Generic
Pharmaceutical Association, and Biotechnology Industry
Organization on the basis that the ordinance violates the
dormant Commerce Clause for interstate commerce and
discriminates against out-of-county producers. In August
2013, the U.S. District Court upheld the ordinance,
although litigation is ongoing. Several other California
counties are considering or have enacted similar
ordinances.
Sharps waste.
4)Medical sharps: An estimated one million Californians inject
medications outside traditional health care facilities, which
generate approximately 936 million sharps each year, and the
numbers of patients using injectable medications will continue
to grow because it is an effective delivery method for various
medications. The most common home use of sharps is to manage
diabetes. Other reasons to inject at home include hepatitis,
multiple sclerosis, infertility, migraines, allergies,
hemophilia, and medications for pets.
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a) Sharps Waste. According to statistics from CalRecycle,
43% of all self-injectors throw needles in the trash.
According to CalRecycle's 2014 waste characterization study,
2014 Disposal-Facility-Based Characterization of Solid Waste
in California, the composition of California's overall
disposed waste stream is dissected by material type. There
is not a line-item for home-generated sharps, but under the
category of HHW is the subcategory "Remainder/Composite
Household Hazardous," which includes household hazardous
material that, if improperly put in the solid waste stream,
may present handling problems or other hazards, such as
pesticides and caustic cleaners, sharps, medications, and
supplements. The 2014 report estimates that
remainder/composite household hazardous materials comprises
more than 94,000 lbs. (0.2%), of the total solid waste
stream.
b) Sharps risk: Improper sharps disposal can affect
janitors, housekeepers, pest control workers,
groundskeepers, waste management workers, and children or
household pets among others. Roughly 25% to 45% of all
facilities processing household trash (besides recycling) in
California have workers hand-sorting recyclable material out
of that trash. A single worker's on-the-job needle stick can
mean weeks of taking drugs to prevent the spread of
infection, with side effects including nausea, depression,
and extreme fatigue as well as months waiting for expensive
periodic tests to reveal whether they contracted
life-threatening HIV/AIDs or hepatitis B or C. According to
CalRecycle, it costs between $154 to $2,411 for
testing/treatment for a single needlestick, and around $4.6
million is spent in California every year due to
needlesticks, primarily for testing for infection and work
loss while testing.
c) In 2013, in connection with AB 1893 (Stone and Eggman)
and a related Senate Labor Committee hearing, the
Legislature requested that the Commission on Health and
Safety and Workers' Compensation review whether provisions
of current law offered sufficient protection against sharps
injuries for workers outside healthcare occupations. As a
result, the University of California, Berkeley (UC Berkeley)
released a March 2015, study, Infection Risk from "Sharps"
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Injuries for Non-healthcare Workers, which found a contrary
view. That study stated, "sharps injuries, outside the
healthcare setting are uncommon. About 1-in-10,000 workers
outside healthcare will experience a needlestick in a given
year. For specific industries (education, food &
hospitality, and waste management) and occupations
(custodial services and protective services), this risk is
substantially higher. However, even in these specific
industries and occupations, the risk of a sharps injury is
less than 1/1000 workers/year."
d) Sharps collection: Home-generated sharps waste is
required to be put into an approved sharps container before
being transported out to an approved drop-off location or
via mail-back program. CalRecycle maintains the Facility
Information Toolbox (FacIT) Website, which currently lists
more than 600 facilities where residents can take their
home-generated sharps such as hospitals, pharmacies, or 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 voluntary
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 some
success.
Currently, out of California's 58 counties, three counties
(Tulare, San Luis Obispo, and Santa Cruz) and two cities
(Galt and Santa Cruz) have an ordinance that has some level
of requirements on retail establishments that sell sharps to
accept the used sharps for proper disposal. Other
jurisdictions are considering a similar ordinance. According
to CalRecycle, approximately 50 counties provide free
disposal. At least eight counties and some cities provide
free sharps containers and one county provides free
mail-back containers to its residents as long as supplies
last.
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e) Sharps collection requirements under the Medical Waste
Management Act (MWMA): DPH has the authority to approve
locations as points of consolidation for the collection of
home-generated sharps waste, which, after collection, is
transported and treated as medical waste. An approved
consolidation location is known as a "home-generated sharps
consolidation point." A home-generated sharps consolidation
point must comply with all of the following requirements:
(1) All sharps waste shall be placed in sharps containers;
and (2) sharps containers ready for disposal shall not be
held for more than seven days without the written approval
of the enforcement agency.
f) Current requirements for sharps manufacturers: Pursuant
to SB 486 (Simitian, Chapter 591, Statutes of 2009), a
pharmaceutical manufacturer that sells or distributes a
medication in California that is intended to be
self-injected at home through the use of a hypodermic
needle, pen needle, intravenous needle, or any other similar
device, is required to submit a plan to CalRecycle that
describes the actions taken by the manufacturer to support
or provide for the safe collection and proper disposal of
the waste devices, and educate consumers about safe sharps
management and collection opportunities. To date, CalRecycle
has received sharps collection and disposal plans from 29
pharmaceutical manufacturers or distributors.
According to the analysis of SB 486, "?with the prohibition of
disposal of sharps in the waste stream and no convenient, cost
effect [sic] 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? The author's office
believes that this bill represents a first step toward developing
an EPR [Extended Producer Responsibility] 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."
In the opinion of the Monterey Regional Waste Management
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District, the voluntary provisions of SB 486 are not
working. As of July 1, 2012, there were 31 plans submitted
to CalRecycle, which were read and graded by a 9-person
evaluation team, scoring each plan based on published
consumer criteria. The Senate Bill 486 Evaluation Team
Consumer Report Card found that, of those 31 manufacturer
reports, 20, or nearly 65% of all submitted reports, were
graded an F. In addition, 8 other manufacturers were graded
"F/Incomplete" for not submitting plans by the legislatively
mandated deadline of July 1 and being in violation of state
law.
Waste Management.
5)Waste management. Managing the waste stream is a very
expensive and often burdensome task for local governments.
Cities and counties spend upwards of $500 million annually to
manage products prohibited from landfills as well as those
lawfully disposed of at the landfill -- a cost that local
governments ultimately pass along to the consumer in the form
of fees on solid waste services.
The environmental impacts of improper disposal are serious in
their own right, but they also serve as a warning and potential
threat on human health and safety. This creates an incredible
public health and environmental burden for federal, state and
local governments to attempt to deal with difficult, cumbersome
or dangerous waste streams.
In the last 3 decades, California has adopted and implemented a
multitude of policies and laws aimed at lessening the impacts of
waste, to reduce, reuse and recycle as much as possible. As
California's waste management policies have evolved so has the
discussion of responsibility for the costs associated with waste
reduction and disposal. Many policies developed today are aimed
at a shared responsibility between the consumer, private and
public sectors with the goal of creating a holistic understanding
and commitment to better design and products that do not harm
public health or the environment from the beginning to the end of
their lifecycle.
Over the years, CalRecycle's predecessor, the California
Integrated Waste Management Board, engaged in a variety of
program activities concerning products and their impact on the
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environment. These efforts continue as CalRecycle seeks a
comprehensive approach for advancing efficient, effective shared
waste management solutions, building upon the efforts elsewhere
in the world.
Most CalRecycle activities in the past have focused on better
managing the impacts of product discards, rather than focusing on
how to eliminate waste in the first place. Extended producer
responsibility (EPR) is a waste reduction strategy. By shifting
costs and responsibilities of product discards to producers and
others who directly benefit, EPR provides an incentive to
eliminate waste and pollution through product design changes. It
allows CalRecycle to better carry out its mission for the
citizens of California.
In February 2007, the California Integrated Waste Management
Board adopted a set of Strategic Directives that included
Strategic Directive 5: Producer Responsibility: This policy
directs staff to seek statutory authority to foster
"cradle-to-cradle" producer responsibility and develop
producer-financed and producer-managed systems for product
discards.
6)Waste-Management Theories.
a) Extended producer responsibility: CalRecycle 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. 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.
By shifting costs and responsibilities of product disposal
to producers and others who directly benefit, EPR provides
an incentive to eliminate waste and pollution through
product design changes.
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There are a number of existing, statewide EPR programs for
various products, including, but not limited to, paint, used
oil, and, most recently, mattresses.
EPR, and take-back laws in particular, provides that
manufacturers should be forced to internalize disposal costs
and environmental externalities associated with their
products. EPR involves: 1) the shifting of responsibility
(physically and/or economically; fully or partially)
upstream toward the producer and away from the
municipalities; and, 2) to provide incentives to producers
to incorporate environmental considerations in the design of
their products.
b) Product Stewardship. Product Stewardship is closely
related to EPR. Product stewardship programs usually
involve voluntary approaches and multi-stakeholder dialogues
between state governments, industry, and consumer and
environmental groups to arrive at better management
practices for particular products. Product stewardship
differs from EPR in that responsibility is shared across the
chain of custody.
c) Advance Recovery Fee (ARF). A consumer-financed ARF is
an alternative to producer-financed systems. Typically,
retailers forward the proceeds to a governmental authority
that would fund municipal collection centers and subsidize
private recycling operations to make recycling economical.
Tax incidence theory holds that some of the ARF would
actually be absorbed by manufacturers or retailers, so the
burden of funding the new recycling infrastructure would be
shared. In California, e-waste is an example of an ARF
program.
From the perspective of state and local governments, ARFs may
be considered beneficial because they provide a steady
source of revenue to fund the recycling infrastructure
needed to manage waste, including "historic waste" which are
used products already on the market when an ARF is enacted.
In California, local governments are generally responsible
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for dealing with the illegal dumping of mattresses, which
can be costly to the local governments. For example, the
author notes that the City of Oakland currently picks up and
disposes of approximately 18 to 35 illegally dumped
mattresses per day, which annually costs the city $501,355.
Many manufacturers favor an ARF as well, because it leaves
producers out of the collection and recycling process and
may lead to a steady supply of subsidized secondary
materials.
An ARF helps consumers understand that there is a real
environmental consequence and disposal cost for products
that they purchase. Such a fee also helps provide consumer
awareness that pollution is not solely caused by industrial
firms, but by individual consumption decisions as well.
Comments
Purpose of Bill.
1)Purpose of the bill. According to the author, disposal of
unused drugs and used sharps is a legitimate issue that the
Legislature has attempted to address without success. The
author states that local jurisdictions have attempted to
address the issue as well, with mixed results. Industries
within the medication and sharps supply chain believe they can
be helpful to local jurisdictions in their efforts to manage
these products, but believe the type of partnership set forth
in the bill will yield better results and foster a more
productive working relationship. Industry proponents want to
place a moratorium on adoption of local ordinances mandating
industry responsibility for a five-year period to see if this
approach can be successful.
The author believes the effort to address the issue of
management of disposal of these products has become incredibly
contentious and has not resulted in effective mechanisms for
disposal. The author further states that these products do not
fit neatly into that concept, which has resulted in management
approaches that can be very expensive and difficult to
implement and manage. In addition, the author feels the
premises upon which many ordinances are based are not supported
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by the facts. The author believes that programs at the local
level that might well be effective would benefit from
assistance from industry that is principally focused on
consumer education and targeted support for disposal
infrastructure.
2)Bill in print. AB 45 requires CalRecycle to adopt one or more
model ordinances for a comprehensive program for the collection
of household hazardous waste (as defined by this bill), and
allows a local jurisdiction to adopt one of the model
ordinances. Requires CalRecycle to determine whether an
appropriate nonprofit organization has been created and funded
for the purpose of making grants to local governments to assist
with educating residents of communities on the existence of HHW
disposal programs and how to use them; and, defray the cost of
components of local government HHW programs.
There are numerous concerns that range from the construct of
how the bill is written to the specific policy provisions of
the current bill that would make it difficult, if not
impossible, to implement the legislation. The most concerning
provisions are as follows:
a) Model ordinances. Over the last several
decades CalRecycle, DTSC and local governments have
been contemplating and developing model solutions for
the different regions of the state for different waste
streams that reflect the emerging needs of California
communities. While developing and making available a
menu of model solutions is valuable to advise local
jurisdictions in constructing their own solutions for
safely and effectively executing their waste management
mandates, it is not necessary or constructive to limit
those solutions to new ordinances. As stated, local
governments are already required to create waste
solutions and have been doing so for many decades, to
limit the tools for integrating new solutions to
ordinances as specified by CalRecycle does not provide
local jurisdictions the needed flexibility to manage
their programs.
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b) Non-profit. The bill contains a lack of
specificity around what the non-profit identified in
this bill would be and how it would be overseen by or
accountable to the state for allocating grants.
Additionally, the bill does not require that the
non-profit be created. If it is created but found by
CalRecycle to be "inappropriately" created or
insufficiently funded then the provisions of this bill
cease to exist as of January 1, 2019.
Legislation is not needed to create optional non-profit
granting entities. The industry could do this today.
The only reason to put this provision in legislation is
to make the non-profit grants contingent on a
legislatively mandated prohibition on local governments
adopting their own ordinances for the management of
pharmaceutical and sharps waste.
It would be inappropriate for the Legislature to trade
local government control over how local jurisdictions
comply with the mandate that they safely and
effectively collect and dispatch these difficult waste
streams in exchange for an optional grant program that
would be controlled and implemented by the
pharmaceutical industry.
Additionally, a grant program that focuses on an
educational campaign does not help local governments
develop effective new solutions for the waste.
c) Grant Funding. The bill specifies that $5
million dollars would be made available to implement a
grant program for educating residents of communities on
the existence of HHW disposal programs and how to use
them; and, defray the cost of components of local
government HHW programs.
As outlined in the background, one of the difficulties
AB 45 (Mullin) Page 19
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in successful collection and disposal of HHW,
pharmaceutical waste and sharps waste is participation.
Low consumer participation rates are not attributed to
a lack of willingness or education on the part of the
consumer. Rather, the problem is the lack of resources
to make the myriad solutions developed to date
conveniently and readily available to consumers and to
implement newly emerging solutions. This is
illustrated in the high participation and collection
rates of the many take-back days conducted across the
state as well as the solutions that have been in
existence in other countries for many years.
Additionally, defraying the current costs associated
with HHW local programs does not help create expanded
or new solutions to encourage greater and more success
participation.
3)Suggested Amendment. The bill in its current form does not
reflect the direction that California and its local elected
governments have chosen to evolve waste management policy for
the best protection and service to the state and its
communities.
The bill should be amended to strike the current contents of
the bill and replace with language that will help
Californians develop successful and efficient solutions for
handling HHW, pharmaceutical and sharps waste streams that
result in increased successful collection of HHW,
pharmaceutical waste and sharps waste.
Given the extensive amount of work done at both the state
and local levels to review, research and develop efficient,
effective and safe waste management strategies, what is
needed at this juncture is the opportunity to test new as
well as proven strategies in various types of communities to
inform future government policies for waste management of
HHW, pharmaceutical and sharps waste.
The bill should be amended to create a pilot project in Los
Angeles
to develop and implement various strategies for different
communities for HHW, pharmaceutical waste and sharps waste
AB 45 (Mullin) Page 20
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that are aimed at increasing participation and providing
safe and effective options for the appropriate handling of
these waste streams. (Because of the sheer size and
demographic of the many communities in Los Angeles County,
this county is a good microcosm of the state to test
strategies.)
The pilot is to be created by CalRecycle in
consultation with DTSC. CalRecycle will create an
advisory committee for the pilot that consists of
CalRecycle, DTSC, County of Los Angeles, other local
government representatives, industry representation and
other entities that can advise on waste management
strategies.
The pilot will be executed by the County of Los
Angeles, if the county agrees, through a grant of $3 to
5 million a year for 3 years from participating
pharmaceutical companies.
The pilot shall include periodic reports as
well as a final report (as specified by CalRecycle)
that outlines the success of the various strategies
implemented in the pilot including tracking of
participation rates and other data as deemed
appropriate by CalRecycle.
While Los Angeles County is conducting this
pilot project, the county and the municipal
jurisdictions within the county shall not adopt
ordinances for the disposal of pharmaceutical waste
that are paid for at the direct cost of the
pharmaceutical industry.
Related/Prior Legislation
AB 2039 (Ting, 2016) proposes building on the models of the
aforementioned programs to develop EPR for home-generated
medical sharps. This bill was referred to the Assembly
Committee on Environmental Safety and Toxic Materials. Hearing
was cancelled at request of the author.
SB 1229 (Jackson/Stone, 2016) would provide that an entity
AB 45 (Mullin) Page 21
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registered with the federal Drug Enforcement Agency to receive
a controlled substance for the purpose of destruction is not
liable for civil damages, or subject to criminal prosecution,
for maintaining a secure drug take-back bin on its premise. SB
1229 passed out of the Senate Judiciary Committee on a vote
9-0.
AB 649 (Patterson, 2015) requires Department of Public Health
(DPH) to evaluate and approve an alternative medical waste
treatment method that is designed to treat pharmaceutical waste
by June 1, 2017, and would limit the use of such a technology
by a law enforcement agency. AB 649 was held in the Senate
Appropriations Committee.
AB 1159 (Gordon/Williams, 2015) proposed establishing a pilot
product stewardship program for the management of medical
sharps and household primary batteries. It was approved by the
Assembly Environmental Safety & Toxic Materials Committee on
April 28, 2015 by a 6-0 vote. AB 1159 was held in the Assembly
Appropriations Committee.
SB 225 (Wieckowski, Chapter352, Statutes of 2015) makes various
technical changes to the Medical Waste Management Act (MWMA).
AB 2371 (Mullin, 2014), as heard by the Assembly Local
Government Committee, would have required each jurisdiction, no
later than January 1, 2016, to review its HHW Element to
determine its effectiveness in the collection, recycling,
treatment, and disposal of HHW, and would have required
CalRecycle, on or before January 1, 2017, to submit a report to
the Legislature that analyzes the effectiveness of the state's
HHW management system. AB 2371 was later amended to deal with
a different subject matter.
AB 1727 (Rodriguez, Chapter 155, Statutes of 2014) restricts
certain pharmaceuticals from county operated prescription drug
collection and redistribution programs.
AB 45 (Mullin) Page 22
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AB 1893 (Stone/Eggman, 2014) proposed requiring customers be
given a free sharps disposal container with the sale of 50 or
more medical sharps for self-injection. AB 1893 was pulled by
the author from the Assembly Floor.
ACR 93 (Buchanan, Chapter 23, Statutes of 2014) would declare
March 2014 as Drug Abuse Awareness Month in California, and
encourage all citizens to participate in prevention programs
and activities and to pledge to "Spread the Word? One Pill Can
Kill."
SB 1014 (Jackson, 2014) requires the Department of Resources
Recycling and Recovery (CalRecycle) and the California State
Board of Pharmacy to jointly develop regulations authorizing a
voluntary program to collect and properly dispose of
home-generated pharmaceutical waste. SB 1014 was referred to
the Assembly Appropriations Committee. Hearing was cancelled
at request of the author.
AB 403 (Stone/Eggman, 2013) proposed requiring 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.
AB 333 (Wieckowski, Chapter 564, Statutes of 2013) makes
various changes to the Medical Waste Management Act.
AB 467 (Stone, Chapter 10, Statutes of 2013) creates a
licensure category for a surplus medication collection and
distribution intermediary.
SB 727 (Jackson, 2013) requires a producer of a pharmaceutical
sold in this state, individually or through a stewardship
organization, to submit a plan to CalRecycle by January 1,
2015. This bill was referred to the Senate Environmental
Quality Committee. Hearing was cancelled at request of the
author.
AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defines
pharmaceutical waste, exempted the waste generator from certain
hauling requirements, and allowed the waste to be transported
by a common carrier in order to reduce costs for handling
AB 45 (Mullin) Page 23
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expired pharmaceutical wastes.
SB 966 (Simitian/Kuehl, Chapter 542, Statutes of 2007) requires
the Integrated Waste Management Board to identify and develop
model programs for the safe disposal of household generated
pharmaceutical waste.
AB 2335 (Saldana, Chapter 166, Statutes of 2006) makes various
clarifying changes to the MWMA with the aim of reducing medical
waste management costs and clarifying the complex regulatory
framework.
SB 1305 (Figueroa, Chapter 64, Statutes of 2006) prohibits a
person from knowingly placing home-generated sharps waste in
the commercial and residential solid waste collection
containers after September 1, 2008.
SB 1362 (Figueroa, Chapter 157, Statutes of 2004) allows a
household hazardous waste collection facility to operate as a
home-generated sharps consolidation point if certain conditions
are met. The bill also allows a city or county HHW Element to
collect, treat, and dispose of household sharps.
SB 407 (Alpert, Chapter 139, Statutes of 1999) authorizes the
use of chemical disinfection as a treatment method for certain
types of laboratory-generated medical waste if specified
requirements were met.
SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the
management and handling of waste pharmaceuticals under DPH and
the MWMA and reestablished fee authorities for DPH for small
quantity medical waste generators.
SB 372 (Wright, Chapter 877, Statutes of 1995) makes various
changes to the MWMA, including revisions to the definition of
large quantity generator, medical waste exclusions, and
storage. The bill also incorporated additional classes into
the definition of medical waste and authorized the use of high
temperatures to treat medical waste prior to disposal.
SB 1360 (Committee on Health and Human Services, Chapter 415,
Statutes of 1995) moved the MWMA to the DPH during Governor
Wilson's reorganization of the Department of Health Services to
DPH and the California Environmental Protection Agency.
AB 45 (Mullin) Page 24
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SOURCE: Author
SUPPORT:
Advanced Medical Technology Association (AdvaMed)
Biocom
California Life Science Association
California Pharmacists Association
California Retailers Association
Consumer Healthcare Products Association
Generic Pharmaceutical Association
National Association of Chain Drug Stores
OPPOSE:
Alameda County Board of Supervisors
Alameda County Hazardous Materials Facility
Alameda County Meds Coalition
Alameda StopWaste
Butte County Board of Supervisors
California Association of Environmental Health Administrators
California Association of Retired Americans
California Environmental Health Directors
California Hepatitis C Task Force
California League of Conservation Voters
California Product Stewardship Council
California Refuse Recycling Council
California Resource Recovery Association
California State Association of Counties
Californian's Against Waste
City and County of San Francisco
City of Burbank
City of Camarillo
City of Chula Vista
City of Claremont
City of Clovis
City of Commerce
City of Culver City
City of Cupertino
City of Diamond Bar
City of Lakewood
City of Mountain View
City of Palo Alto
AB 45 (Mullin) Page 25
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City of Pasadena
City of Roseville
City of Santa Monica
City of Stockton
City of Sunnyvale
City of Thousand Oaks
City of Torrance
City of West Hollywood
Clean Water Action
Contra Costa County Board of Supervisors
County of Sacramento
Del Norte Solid Waste Management Authority
Delta Diablo
Goodwill Industries of San Francisco, San Mateo, and Marin
Green Sangha of Marin
Health Officers Association of California
Hope2gether Foundation
Kern County Board of Supervisors
Kern County Public Works Department
League of California Cities
League of Women Voters of California
Los Angeles County Board of Supervisors
Los Angeles County Department of Public Works
Los Angeles County Solid Waste Management Committee/Integrated
Waste
Management Task Force
Marin County Board of Supervisors
Marin County Pharmacist Association
Marin Household Hazardous Waste Facility
Marin Sanitary Service
Mojave Desert and Mountain Recycling Authority
Napa County Board of Supervisors
Napa Recycling and Waste Services
Napa Sanitation District
Napa Upper Valley Waste Management Agency
National Association of Hazardous Materials Managers, California
Chapter and
National Coalition Against Prescription Drug Abuse
Peninsula Sanitary Service, Inc.
Pharmacy Defense Fund
Pharmacy Planning Service, Inc.
Planning and Conservation League
Recology
Riverside County Department of Waste Resources
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Rural County Representatives of California
Russian River Watershed Association
Salinas Valley Recycles
San Joaquin County Public Works
San Luis Obispo County Integrated Waste Management Authority
Sanitation Districts of Los Angeles County
Santa Barbara County
Santa Barbara County Board of Supervisors
Santa Clara County Board of Supervisors
Santa Clara County, Recycling and Waste Reduction Commission
Santa Cruz County Board of Supervisors
Santa Monica Mayor Tony Vazquez
Seventh Generation Advisors
Sierra Club California
Solano County Board of Supervisors
Solid Waste Association of North America
Solid Waste Solutions, Inc.
Sonoma County Board of Supervisors
Sonoma County Waste Management Agency
Sonoma County Water Agency
Stanislaus County
StopWaste
Surfrider Foundation
Teamsters Local 396
Tulare County Board of Supervisors
Upper Valley Waste Management Agency
Urban Counties of California
Waterkeeper
Western Placer Waste Management Authority
Yolo County Board of Supervisors
Zero Waste Marin
ARGUMENTS IN SUPPORT:
Supporters believe that "it is critical that dialogue continues
on HHW disposal. AB 45 is a critical piece of that conversation,
and its continued progress will allow those conversations to
continue within the framework and sense of urgency that active
legislation creates."
ARGUMENTS IN OPPOSITION:
Local jurisdictions throughout the state strongly oppose AB 45.
Dozens of letters from various sizes and types of jurisdictions
AB 45 (Mullin) Page 27
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have been submitted to the committee which outline the successful
collection of hundreds of thousands of pounds of HHW,
pharmaceutical waste and sharps waste within those jurisdictions.
What appears as a constant frustration, is the lack of resources
to do more.
"Local jurisdictions have historically been authorized to develop
and implement HHW collection, recycling, and educational programs
which reflect local needs. AB 45 would instead create a
one-size-fits-all approach which may not reflect local conditions
and would do little to support efforts to reduce HHW generation.
AB 45 would discourage and undermine efforts by local governments
to implement extended producer responsibility (EPR) programs for
uniquely problematic wastes, such as HHW, pharmaceutical waste,
and sharps waste. Many jurisdictions in California have adopted
pharmaceutical take-back ordinances, and our Board is considering
the adoption of a pharmaceutical and sharps waste EPR ordinance,
in which manufacturers would provide safe, convenient and
sustainably financed take-back programs for their products at the
end of their useful life.
AB 45 does not provide a source of funding to sustainably collect
and process waste, and limits the industry's role in managing HHW
to outreach only, which is contrary to Los Angeles County's
support for EPR policies that place shared responsibility for
end-of-life product management on all entities involved in a
product chain, including producers."
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