BILL ANALYSIS �
SB 1014
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Date of Hearing: June 24, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 1014 (Jackson) - As Amended: June 18, 2014
SENATE VOTE : 33-3
SUBJECT : Pharmaceutical waste: home generated: collection.
SUMMARY : Requires the Department of Resources Recycling and
Recovery (CalRecycle) and the California State Board of Pharmacy
(BOP) to jointly develop regulations authorizing a voluntary
program to collect and properly dispose of home-generated
pharmaceutical waste (HGPW). Specifically, this bill :
1)Authorizes a pharmacy to accept the return of HGPW from a
consumer consistent with the Federal Food, Drug, and Cosmetic
Act and the federal Controlled Substances Act.
2)Defines the terms "HGPW," "consumer," "entity," "participant,"
and "sale."
3)Specifies that HGPW is not medical waste, as specified.
4)Requires, by January 1, 2016, CalRecycle and BOP to jointly
develop regulations, to be approved by both agencies before
adoption, authorizing a participant to establish a program to
collect and properly dispose of HGPW. Requires the
regulations to be based upon the model guidelines developed by
CalRecycle, as specified, and to include the following:
a) Provisions requiring a participant to:
i) Provide, at no additional cost to the consumer, for
the safe take back and proper disposal of
pharmaceuticals;
ii) Ensure the protection of the public health and
safety, the environment, and the health and safety of
consumers and employees;
iii) Report to CalRecycle for purposes of evaluation, the
safety, efficiency, and effectiveness of the implemented
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program on an annual basis. Requires the report to
contain both qualitative and quantitative measures, as
determined by CalRecycle.
iv) Protect against the potential for the diversion of
pharmaceutical waste for unlawful use or sale; and,
v) Provide notices and materials, as specified, to
consumers that provide information about the potential
impacts of improper disposal of HGPW and the return
opportunities for the proper disposal of HGPW;
b) Provisions that:
i) Specify the types of participants authorized to
maintain permanent collection locations;
ii) Specify any requirements for obtaining state permits
or approvals;
iii) Require participants to enter into arrangements with
medical or hazardous waste haulers, including ensuring
that all HGPW is appropriately picked up and transported
by registered waste haulers;
iv) Specify which HGPW may be included in a program,
including requirements for the collection of a controlled
substance;
v) Specify methods for handling wastes commingled in
containers with other household waste or hazardous waste;
vi) 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;
vii) Provide that a facility that collects HGPW is
responsible for ensuring that the storage, removal, and
transportation of containers and the disposal of the
waste are in compliance with state laws and regulations;
viii) Require the collection and retention of detailed
information and invoices for each collection site;
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ix) Impose requirements for one-time or periodic
collection events and for mail-back collection and
disposal programs;
x) Provide for the appropriate management of
consolidated HGPW to ensure the public health and safety.
5)Deems a participant operating a program in accordance with the
HGPW regulations to be in compliance with all state laws and
regulations concerning the handling, management, and disposal
of HGPW.
6)States that nothing in this bill prohibits an entity with a
HGPW program that existed as of January 1, 2015, from
continuing to operate.
7)States that no reimbursement is required by this act because
the only costs that may be incurred by a local agency or
school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction,
changes the penalty for a crime or infraction, or changes the
definition of a crime, as specified.
EXISTING LAW :
1)Requires, under the federal Controlled Substances Act,
protocols for the collection of controlled substances to
prevent their illegal diversion and abuse. (21 United States
Code (USC) Section 801 et seq.)
2)Establishes the Federal Food, Drug, and Cosmetic Act,
administered by the United States Food and Drug Administration
(FDA), to regulate drugs and medical devices. (21 USC 301 et
seq.)
3)Establishes the Pharmacy Law, which provides for the licensure
and regulation of pharmacies, pharmacists, and wholesalers of
dangerous drugs or devices by BOP within the Department of
Consumer Affairs. (Business and Professions Code Sections
4000 et seq.)
4)Authorizes a pharmacy to accept the return of needles and
syringes from the public if contained in a sharps container.
(BPC 4146)
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5)Establishes the California Uniform Controlled Substances Act,
which regulates controlled substances. (Health and Safety
Code (HSC) Sections 11000 et seq.)
6)Defines "drug" as substances recognized as drugs in the
official United States Pharmacopoeia, official Homeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them; substances
intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or animals; and,
substances (other than food) intended to affect the structure
or any function of the body of man or animals. (HSC 11014)
7) Establishes the Medical Waste Management Act (MWMA) which
regulates the generation, handling, storage, transport,
treatment, and disposal of medical waste, as defined, and is
overseen by the Department of Public Health (DPH) and
designated local agencies. (HSC 117600 et seq.)
8) Defines "pharmaceutical" as a prescription or
over-the-counter human or veterinary drug including, but not
limited to, a drug as defined in the Sherman Food, Drug and
Cosmetic Law or the Federal Food, Drug, and Cosmetic Act.
(HSC 117747)
9) 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. (HSC 117748)
10)Specifies that waste comprised only of pharmaceuticals is
biohazardous, and is considered "medical waste." (HSC
117635)
11)Requires all medical waste transported to an offsite medical
waste treatment facility to be transported by a registered
hazardous waste transporter. (HSC 118000)
12)Establishes a voluntary drug repository and distribution
program for the purpose of distributing surplus medications
to persons in need of financial assistance to ensure access
to necessary pharmaceutical therapies. (HSC 150200 et seq.)
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13)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. (Public Resources Code Section 47115)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill requires CalRecycle and BOP to
develop regulations authorizing a voluntary program for
participants to properly dispose of HGPW. These programs are
intended to support clean water efforts and reduce drug
diversion. This bill is sponsored by the California Product
Stewardship Council, Clean Water Action, the Alameda County
Board of Supervisors, and the California Alliance for Retired
Americans.
2)Author's statement . According to the author's office,
"California is experiencing an increasingly serious problem
with prescription drug abuse, accidental poisonings, and the
detection of pharmaceutical products in state waters. Local
governments have struggled to establish safe and convenient
medication take-back programs for the unused and expired
prescription drugs, over the counter drugs, and veterinary
drugs found in our homes. Unused medications are often
flushed or thrown in the trash because there are few, if any,
safe and convenient options? Now that CalRecycle's Model
Guidelines have expired, there are no standards in place for
how local entities should properly run their voluntary
take-back programs to ensure that collection and disposal is
safe, convenient, and secure. Due to the prescription drug
abuse epidemic in the state, guidelines for collection to
prevent further diversion are critical to protecting public
health-they can help by providing local entities with a model
for removing unwanted drugs from homes and ensuring they are
not resold or available to be abused after consolidation at
collection locations."
3)Environmental and social impacts of improperly disposed
pharmaceuticals . Improperly managed pharmaceuticals are
resulting in environmental and health concerns and drug
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diversion.
a) Environmental concerns . Pharmaceuticals in our water
supply are an issue of growing concern and significant
research. Pharmaceutical residuals from humans and animals
are continually introduced to the aquatic environment as
complex mixtures through a number of routes -- discharge of
treated domestic wastewater, treated industrial wastewater,
commercial animal feeding operations, and manure.
The World Health Organization released a report in 2011 on
pharmaceuticals in drinking water, concluding that while
the available research indicates there is low immediate
risk to human health from trace pharmaceuticals in drinking
water, there are "knowledge gaps" in the available
literature, and much more research is needed about
long-term effects. Real demonstrated effects on aquatic
life have been demonstrated; the Environmental Protection
Agency reports that results of fish studies indicate
increased resistance to antibiotics and disruption of fish
endocrine systems.
b) Drug diversion . Prescription drug abuse is a serious and
growing problem nationwide. According to the 2010
National Survey on Drugs Use and Health, an estimated 2.4
million Americans used prescription drugs non-medically for
the first time in the past year. This averages about 6,600
initiates per day, of which one-third are 12 to 17 years of
age. The US Department of Justice reports that 70% of youth
get their prescription drugs from family and friends, but
few parents report safeguarding prescription medications.
In addition, the percentage of respondents who agreed with
the survey statement "Anyone can access prescription
medicines in the medicine cabinet" went from 50% in 2010 to
64% in 2011, meaning medications are available to anyone in
their homes.
4)California take-back programs . Take-back programs and events
are collection methods aimed at reducing the quantity of
unused pharmaceuticals entering the environment and reducing
the amount of drugs available for diversion, theft, or
accidental poisoning.
Senate Bill 966 (Simitian, Chapter 542, Statutes of 2007)
required California Integrated Waste Management Board (CIWMB,
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the predecessor to CalRecycle) to develop model programs for
the collection from consumers and proper disposal of unused or
expired HGPW. "Criteria and Procedures for Model
Home-Generated Pharmaceutical Waste Collection and Disposal
Programs," (Model Guidelines) was adopted in 2010 in
consultation with staff from CIWMB, DPH, BOP, Department of
Toxic Substances Control, and the State Water Resources
Control Board. The model program was meant to assist
organizations and local governments in creating programs
through which the public may return unused or expired HGPW, as
well as to meet the minimum criteria and goals delineated in
SB 966.
CalRecycle surveyed 256 collection sites (85% of known
California programs) in 2010 and found no reported signs of
illegal drug diversion. However, only about one-third of the
programs met the voluntary model guidelines. CalRecycle found
that collection programs in California gathered approximately
200,000 pounds of HGPW per year.
A 2014 CalRecycle report to the California State Senate
suggested that program participants faced a number of
challenges that limited program participation. These
challenges include funding concerns, conflicting collection
and disposal standards for medical waste, and burdensome and
confusing regulations and regulatory authorities. The statute
containing the HGPW model guidelines became inoperative on
January 1, 2013, although many programs continue to operate.
This bill builds upon the Model Guidelines in an effort to
create more feasible guidelines for entities wishing to
participate in take-back programs.
5)Committee amendments . In December 2012, the DEA released
proposed regulations to implement the Secure and Responsible
Drug Disposal Act, P.L. 111-273, which was signed into law in
October 2010. The Secure and Responsible Drug Disposal Act
gives the Attorney General authority to promulgate regulations
to allow patients to deliver unused prescription controlled
substances "to appropriate entities for disposal in a safe and
effective manner consistent with effective controls against
diversion." DEA is working on the final rule presently.
Committee amendments strike existing language that
grandfathers programs operating as of January 1, 2015, and
requires that regulations adopted pursuant to this bill
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conform with federal requirements, once they are finalized.
This will require all programs to conform with California's
and DEA regulations.
On page 7, strike lines 3-5, and insert: "47123. Regulations
adopted pursuant to this article shall conform to federal
requirements for drug take-back programs once finalized."
There are additional nonsubstantive technical, clarifying, and
conforming amendments.
6)Arguments in support . California Association of Sanitation
Agencies (CASA) write, "The current lack of safe and
convenient disposal mechanisms in many jurisdictions ensures
that consumers often choose less than desirable options,
including flushing medications down the toilet. Attention to
the environmental impact of pharmaceuticals has grown among
water quality regulators in California, and as a result, many
wastewater treatment plants are now being required to monitor
for these concentrations out of wastewater, and there are
varying degrees of removal capability for each constituent
type. As a consequence, some pharmaceuticals disposed of
through the wastewater stream and their metabolites may pass
through wastewater treatment plants into creeks, rivers, bays
and the Pacific Ocean.
"Many CASA member agencies have spent significant time and
resources developing pharmaceutical take-back programs,
implementing "No Drugs Down the Drain" campaigns and hosting
take back collection days as part of household hazardous waste
programs."
7)Related legislation . AB 403 (Stone) of 2013 would have
required businesses that sell medical sharps to establish a
product stewardship plan for the end of life management of
home-generated medial sharps. The bill was held under
submission by the Assembly Committee on Appropriations.
AB 467 (Stone, Chapter 10, Statutes of 2014) created a
licensure category for a surplus medication collection and
distribution intermediary.
AB 1727 (Rodriguez) of 2014 exempts a prescription drug under
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a federal FDA Risk Evaluation and Mitigation Strategies from
being donated through a prescription drug donation program.
Status: This bill is currently pending in the Senate
Committee on Business, Professions, and Economic Development.
AB 1893 (Stone and Eggman) of 2014 requires that customers be
given a free sharps disposal container with the sale of 50 or
more medical sharps for self-injection. Status: This bill
is currently pending on the Assembly floor.
8)Previous legislation . AB 1442 (Wieckowski) Chapter 689,
Statutes of 2012, defined pharmaceutical waste as any
pharmaceutical that may no longer be sold or dispensed,
excluding pharmaceuticals that could be returned to a reverse
distributor for possible manufacturer credit.
SB 419 (Simitian) of 2011, required pharmaceutical
manufacturers to provide their annual reports on disposal of
sharps waste to CalRecycle electronically and make them
readily available on their websites. The bill was vetoed by
the Governor.
SB 26 (Simitian) of 2009 would have defined HGPW and exempt
it from existing regulatory requirements for the handling of
medical waste and would have authorized pharmacies and other
facilities to collect HGPW, under specified conditions.
Status: The bill was amended to deal with a different topic
and was not heard in a policy committee.
SB 486 (Simitian) Chapter 591, Statutes of 2009, required a
pharmaceutical manufacturer that sells or distributes a
medication that is self-injected at home through the use of a
hypodermic needle, pen needle, intravenous needle, or any
other similar devices to submit to the CIWMB, or its
successor agency, a plan that describes how the manufacturer
supports the safe collection and destruction of
home-generated sharps waste.
SB 966 (Simitian), Chapter 542, Statutes of 2007, required
CIWMB to develop, in consultation with appropriate state,
local, and federal agencies, model programs for the
collection and proper disposal of pharmaceutical drug waste.
9)Double referral : This bill was previously heard in the
Environmental Safety and Toxic Materials Committee and was
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passed by a 6-1 vote.
REGISTERED SUPPORT / OPPOSITION :
Support
Alameda County Board of Supervisors (co-sponsor)
California Alliance for Retired Americans (co-sponsor)
California Product Stewardship Council (co-sponsor)
Clean Water Action (co-sponsor)
California Nurses Association
California School Employees Association
California State Board of Pharmacy
California State Sheriff's Association
Central Contra Costa County Sanitation District
City and County of San Francisco
City of Sunnyvale
County of Santa Clara
East Bay Municipal Utility District
El Dorado Irrigation District
Rural County Representatives of California
Los Angeles County Board of Supervisors (05/27/14 version)
California Association of Sanitation Agencies (04/21/14 version)
California Resource Recovery Association (04/21/14 version)
City of Camarillo (04/21/14 version)
City of Chula Vista (04/21/14 version)
Health Officers Association of California (04/21/14 version)
League of Women Voters of California (04/21/14 version)
Natural Resources Defense Council (04/21/14 version)
Sacramento State Student Health Services Pharmacy (04/21/14
version)
San Francisco Bay Area Physicians for Social Responsibility
(04/21/14 version)
Sanitation Districts of Los Angeles County (04/21/14 version)
Worksafe (04/21/14 version)
Californians for a Healthy and Green Economy (04/1/14 version)
Center for Environmental Health (04/1/14 version)
City of Thousand Oaks (04/1/14 version)
City of Torrance (04/1/14 version)
Opposition
One individual
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Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301