BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 1014|
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THIRD READING
Bill No: SB 1014
Author: Jackson (D), et al.
Amended: 5/27/14
Vote: 21
SENATE ENVIRONMENTAL QUALITY COMMITTEE : 5-1, 3/26/14
AYES: Hill, Hancock, Jackson, Leno, Pavley
NOES: Gaines
NO VOTE RECORDED: Fuller
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMMITTEE : 6-0, 4/21/14
AYES: Lieu, Block, Corbett, Hernandez, Hill, Padilla
NO VOTE RECORDED: Wyland, Berryhill, Galgiani
SENATE APPROPRIATIONS COMMITTEE : 5-1, 5/23/14
AYES: De Le�n, Hill, Lara, Padilla, Steinberg
NOES: Gaines
NO VOTE RECORDED: Walters
SUBJECT : Pharmaceutical waste: home-generated
SOURCE : Alameda County Board of Supervisors
California Alliance for Retired Americans
California Product Stewardship Council
Clean Water Action
DIGEST : This bill establishes the Home-Generated
Pharmaceutical Waste Collection and Disposal Act to be
administered by the Department of Recycling and Recovery
(CalRecycle) according to certain guidelines. This bill
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authorizes a pharmacy to accept the return of home-generated
pharmaceutical waste (HGPW) from a consumer. This bill provides
that HGPW under a collection and disposal program is not medical
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 cosmetics.
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.
Existing state law:
1.Under the California Hazardous Substances Act, the Department
of Toxic Substances Control (DTSC) is authorized to regulate
hazardous materials and wastes in accordance with RCRA.
2.The California Integrated Waste Management Act:
A. Requires CalRecycle to implement a statewide household
hazardous waste substance information and collection
program.
B. Authorizes local jurisdictions to include in their
Household Hazardous Waste Elements a program for the safe
management of sharps waste.
C. 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.
1.The Medical Waste Management Act (MWMA):
A. Requires the California Department of Public Health
(DPH) to regulate the management and handling of medical
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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 "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.
D. Specifies that waste comprised only of pharmaceuticals
is biohazardous, and is considered "medical waste."
This bill:
1.Establishes the Home-Generated Pharmaceutical Waste Collection
and Disposal Act.
2.Authorizes a pharmacy to accept the return of HGPW from a
consumer.
3.Defines "HGPW" for the purposes of the MWMA as a prescription
or over-the-counter human or veterinary home-generated
pharmaceutical, including, but not limited to, a
home-generated pharmaceutical as defined under federal law
that is waste derived from a household, including, but not
limited to, a multifamily residence or household.
4.Provides that medical waste does not include HGPW, including
but not limited to, consolidated HGPW, that is handled by a
collection and disposal program operating in accordance with
regulations adopted by CalRecycle.
5.Makes the following definitions in the Public Resources Code
related to HGPW collection and disposal:
A. "Consumer" is an individual purchaser or owner of a
pharmaceutical and does not include a business,
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corporation, limited partnership or entity involved in a
wholesale transaction between a distributor and a retailer.
B. "Entity" is a state or local public agency, pharmacy
veterinarian clinic or other office or facility.
C. "HGPW" means the same as above and includes all of the
following:
Articles recognized in the official United States
Pharmacopoeia, the official National Formulary, the
official Homeopathic Pharmacopeia of the United States or
any supplement of the formulary or those pharmacopoeias.
Articles intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in humans
or other animals.
Articles, excluding food, intended to affect the
structure or function of the body of humans or other
animals.
Articles intended for use as a component of an
article specified above.
A. "Participant" is an entity that CalRecycle deems
appropriate for implementing and evaluating a program in
accordance with regulations and that chooses to
participate.
B. "Sale" is, but is not limited to, transactions conducted
through sales outlets, catalogs or the Internet, or any
other similar electronic means, but does not include a sale
that is a wholesale transaction with a distributor or
retailer.
1.Requires CalRecycle to adopt regulations authorizing a
participant to establish a program to collect and properly
dispose of HGPW. Specifies that the regulations be based upon
the model guidelines already developed by CalRecycle and
require a participant to do all of the following:
A. Provide, at no additional cost to the consumer, for the
safe take-back and proper disposal of the type or brand of
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pharmaceuticals that the participant sells or previously
sold.
B. Ensure the protection of the public health and safety,
the environment and the health and safety of consumers and
employees.
C. Report to CalRecycle, for the purposes of evaluation,
the safety, efficiency, effectiveness of the implemented
program on an annual basis.
D. Protect against the potential for the diversion of
pharmaceutical waste for unlawful use or sale.
E. Provide notices and materials to consumers that provide
information about the potential impacts of improper
disposal of HGPW and return opportunities for the proper
disposal of HGPW that include Internet Web site links,
telephone numbers on an invoice, information about
opportunities and locations for no-cost HGPW disposal,
prominently displayed and easily visible signage, written
material provided to consumers at the time of purchase or
delivery, reference to the HPW take-back.
1.Requires the regulations to also do the following and
authorizes CalRecycle to revise the regulations if changes
will ensure public health and safety:
A. Specify the types of participants authorized to maintain
permanent collection locations.
B. Specify requirements for obtaining state permits or
approvals.
C. Require participants to enter into arrangements with
medical or hazardous waste haulers to ensure that all HGPW
is appropriately picked up and transported by registered
waste haulers.
D. Specify which HGPW may be included in a program,
including the requirements for the collection of a
controlled substance.
E. Specify methods for handling wastes commingled in
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containers with other household or hazardous waste.
F. Provide methods for collecting and storing HGPW,
including the use of secured containers and ensure that
collected HGPW is not resold, reused, sold, donated or
provided to anyone other than a registered medical or
hazardous waste hauler.
G. Provide that a facility that collects HGPW is
responsible for ensuring that the storage, removal and
transportation of containers and the waste are in
compliance with state laws and regulations.
H. Require the collection and retention of detailed
information and invoices for each collection site.
I. Impose requirements for one-time or periodic collection
events.
J. Impose requirements for mail-back collection and
disposal programs.
AA. Include provisions for the appropriate management of
HGPW to ensure public health and safety.
Background
California's Model Guidelines for Take-Back. In 2007, the
Legislature passed SB 966 (Simitian, Chapter 542) which required
CalRecycle's predecessor, the California Integrated Waste
Management Board (CIWMB), to develop, in consultation with
appropriate state, local, and federal agencies, model programs
for the collection and proper disposal of pharmaceutical drug
waste. Those guidelines were developed in consultation with a
pharmaceutical working group which included CIWMB staff, Board
staff and representatives from the Department of Public Health,
Department of Toxic Substances Control and State Water Resources
Board. The model programs include parameters for both permanent
and occasional take-back event collection sites and also include
a mail back component as an alternative to onsite collection.
The guidelines, "Criteria and Procedures for Model
Home-Generated Pharmaceutical Waste Collection and Disposal
Programs" were adopted by CIWMB in 2009 to provide consumers the
ability to dispose of unwanted prescription and over-the-counter
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drugs without flushing them down the toilet or throwing them in
the garbage (the guidelines did not include controlled
substances which must be returned only to law enforcement).
These guidelines are only guidelines and not currently
enforceable as standards.
Take-Back in California. Absent a statewide program, many
consumers utilize dedicated, one-day take-back opportunities to
safely dispose of medications. These one-time events allow
individuals to dispose of prescription or non-prescription
medications which are taken to a safe disposal site after
collection. 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 million
pounds of medicine from circulation.
Between 2009 and 2010, CalRecycle identified 177 continuous
collection programs at pharmacies and law enforcement offices in
California. In that time, these programs collected more than
200,000 pounds of pharmaceuticals. San Francisco established a
Safe Medicine Disposal Pilot Program in 2012, allowing residents
to return pharmaceuticals (not including controlled substances)
to 13 pharmacies via secured collection bins or any
pharmaceuticals to San Francisco police stations during business
hours. As of October 2013, over 25,800 pounds of
pharmaceuticals had been collected, 93% of which was at the
pharmacy locations. The Los Angeles County Sheriff's Department
launched their Safe Drug Drop-Off program in September 2009
where drug disposal boxes are available 24 hours a day, 365 days
a year outside of sheriff's stations. A total of 21 drop-off
locations have collected over 53,000 pounds of prescription
medication as of September 2013. Santa Clara County currently
has two county agencies that collect and safely dispose of
pharmaceuticals - the county Household Hazardous Waste Program,
which spends roughly $21,600 annually on the collection and
disposal of 7.2 tons of medication a year (1,200 pounds a month)
and a program run by the county sheriff's office at 10
locations. Annually, the program costs the county $41,600 for
10.8 tons of collected and disposed medication. Alameda County
passed a Safe Drug Disposal Ordinance in 2012 that requires
producers of covered drugs (including both brand name and
generic drugs) to operate take-back programs after submitting a
plan to the county's Department of Environmental Health.
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Programs include the creation, administration, promotion, and
payment of the program (including the payment of Alameda
County's costs to administer and enforce the Ordinance).
CalRecycle reports that the average cost of current take-back
programs in California vary from $3-$7 a pound.
Barriers to Broader Implementation of Take-Back. In
implementing take-back programs on a more broad scale throughout
the state, concerns still remain and there are only a small
number of pharmacies currently accepting drugs back from
consumers. Drugs are very heavily regulated throughout each
step of the supply chain and there are even a limited number of
options (all of which are also tightly regulated) for pharmacies
to remove drugs that have not been dispensed. For example, a
pharmacy can return unwanted drugs to the wholesaler the
pharmacy bought the drugs from provided the drug has not expired
or been recalled; wholesalers are Board licensees. Pharmacies
can also return outdated, nonsalable drugs that have not been
dispensed to a reverse distributor, also a Board licensee, for
possible manufacturer credit and destruction. Pharmacies can
provide outdated, nonsalable drugs to licensed hazardous waste
haulers. With regards to mandatory take-back collection sites
within pharmacies, issues have been raised about the potential
for pharmacies to become recycling centers when they are a
location where health care is being provided. Pharmacies have
also expressed concerns over the past number of years that there
may not be the appropriate space needed for proper collection
and cite the costs associated with the appropriate handling of
drug waste.
The 2010 CalRecycle Report found that only about one-third of
existing programs in California meet the model guidelines and
highlighted a number of barriers. According to CalRecycle, law
enforcement programs can readily meet requirements for
collecting controlled substances, but the public may not be
willing to bring pharmaceutical wastes to police stations.
Further, law enforcement agencies themselves have higher
resource allocation priorities. Pharmacies are widespread and
accessible, but they typically do not meet all of the safety
protocols (e.g., regarding collection bins and security)
delineated in guidelines. Household Hazardous Waste facilities
also face similar issues as pharmacies, particularly relative to
safety, and are dependent on local government funding support.
Periodic collection events are somewhat easier to implement for
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local governments and can accommodate large amounts of materials
in a short time, but are not as cost-effective as continuous
collection programs, often do not have safety protocols, and are
subject to local government budgetary constraints. Mail-back
programs can be convenient and safety is not a major concern,
but there are only three such programs in the state and a high
return rate is necessary for the method to be cost-effective.
Related Legislation
AB 333 (Wieckowski, 2013) makes various changes to the Medical
Waste Management Act. The bill is currently in the Senate
Environmental Quality Committee.
AB 467 (Stone, 2013) creates a licensure category for a surplus
medication collection and distribution intermediary. The bill
is currently in the Assembly for concurrence of Senate
amendments.
AB 1727 (Rodriguez, 2014) restricts certain pharmaceuticals from
county operated prescription drug collection and redistribution
programs. The bill is currently in the Assembly Health
Committee.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
One-time costs between $250,000 and $300,000 from the
Integrated Waste Management Fund (special) to CalRecycle to
develop the required regulations.
Ongoing costs between $50,000 and $150,000 from the
Integrated Waste Management Fund (special) to CalRecycle to
receive and analyze reports from HGPW collection program.
SUPPORT : (Verified 5/28/14)
Alameda County Board of Supervisors (co-source)
California Alliance for Retired Americans (co-source)
California Product Stewardship Council (co-source)
Clean Water Action (co-source)
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Bay Area Physicians for Social Responsibility
California State Board of Pharmacy
Californians for a Healthy and Green Economy
Center for Environmental Health
City of Camarillo
East Bay Municipal Utility District
El Dorado Irrigation District
Health Officers Association of California
League of Women Voters of California
Worksafe
ARGUMENTS IN SUPPORT : According to the author's office, this
bill will help ensure that local entities that decide to
conduct voluntary take-back programs have minimum standards to
follow that will help protect public health and safety and the
environment, and protect against the potential for diversion of
pharmaceutical waste for unlawful use or sale. In addition,
this bill provides clarity to existing law, by specifically
authorizing pharmacies to accept the return of home-generated
pharmaceutical waste, should they decide to do so.
RM:AL:nl 5/28/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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