BILL ANALYSIS
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|Hearing Date:April 13, 2009 |Bill No:SB |
| |26 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC
DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 26 Author:Simitian
As Introduced: December 1,
2008Fiscal: Yes
SUBJECT: Home generated pharmaceutical waste.
SUMMARY: Requires the Board of Pharmacy to coordinate with
other state agencies, local governments, drug manufacturers and
pharmacies to develop a program for the take back of
pharmaceutical waste and allows pharmacies to accept the return
of pharmaceutical and sharps waste, as defined.
Existing law:
1)Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or devices by
the California State Board of Pharmacy in the Department of
Consumer Affairs.
2)Defines home-generated sharps and allows hospitals and other
healthcare facilities to accept them from their patients.
Allows the establishment of home-generated sharps
consolidation points including pharmacies, fire stations and
other facilities where home-generated sharps could be
collected and sent for treatment and disposal.
3)Allows existing city and county household hazardous waste
programs to accept sharps waste generated from homes. Allows
household hazard waste plans to be amended to include efforts
to inform and encourage the public to return sharps waste to
designated sharps collection locations or to subscribe to
mail-back programs authorized by the United States Postal
Service (USPS).
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4)Prohibits the disposal of home generated sharps from being
disposed of in the solid waste stream and requires that sharps
be transported only in certain types of containers.
5)Regulates the methods of consolidation, storage and
transportation of medical waste and home-generated sharps
waste.
6)Requires the California Integrated Waste Management Board
(CIWMB), by July 1, 2008, to consult with local, state, and
federal agencies including the Department of Toxic Substances
Control (DTSC), the State Water Resources Control Board
(SWRCB), and the Board of Pharmacy to establish model disposal
programs for waste pharmaceuticals.
7)Requires the CIWMB to establish minimum requirements for model
programs including safety, oversight, diversion prevention,
and ease of use for consumers and authorizes the CIWMB to
develop related emergency regulations if necessary.
8)Requires the CIWMB to report to the Legislature by December 1,
2010, about the efficacy, safety, and cost-effectiveness of
the program, as well as the potential for replicating model
programs statewide.
This bill:
1)Requires the Board of Pharmacy (Board) to coordinate with
other applicable entities to develop policies to properly
manage pharmaceutical waste.
2)Authorizes pharmacies to accept home-generated sharps and
pharmaceutical waste, as defined.
3)Establishes requirements for the management of home-generated
pharmaceutical waste that parallels that for home-generated
sharps waste.
4)Defines "common carrier" as person or company that hauls for
hire goods, including but not limited to, pharmaceutical waste
or home-generated pharmaceutical waste and specifies that
home-generated pharmaceutical waste must have been
consolidated at a location approved by the enforcement agency
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as a home-generated pharmaceutical waste consolidation point.
5)Defines "home-generated pharmaceutical waste" (HGPW) as
prescribed and over-the-counter drugs derived from a
household.
6)Removes HGPW from the definition of medical waste.
7)Defines "pharmaceutical waste" as any pharmaceutical, as
defined, that may no longer be sold or dispensed because it
has expired, is no longer able to be used for its original
intended purpose or has been discarded or consolidated at a
location approved by the enforcement agency as a HGPW
consolidation point.
8)Permits pharmacies, household hazardous waste programs, solid
waste facilities, senior centers or government offices to be
"home-generated pharmaceutical waste consolidation points,"
exempts HPGW consolidation points from permit requirements and
permit/registration fees and establishes the following
parameters for their operation:
a) The location must be approved by the local enforcement
agency for that purpose.
b) The HGPW collected and consolidated at the facility must
be collected and contained in a leak-resistant and
tamper-proof container and placed in a secure area not
accessible by unauthorized persons.
c) Disposal ready containers cannot be held for more than
90 days without the written approval of the enforcement
agency.
d) Specifies that the HGPW consolidation point operator is
not considered a generator of that waste.
e) Requires the end disposal facilities that treat the HGPW
to maintain tracking documents for the pharmaceutical
waste.
9)Requires, if applicable, the name of the common carrier used
by small and large quantity generators to transport the
pharmaceutical waste for offsite treatment and disposal to be
included on the medical waste management plan submitted to the
local enforcement agency. This applies only to those small
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quantity generators required to register with the enforcement
agency.
10)Requires small quantity generators who are not required to
register with the local enforcement agency to maintain office
records, for no less than two years, the name of the common
carrier used to haul pharmaceutical waste.
11)Exempts small quantity generators or common carriers
transporting HGPW from the medical waste transportation
requirements.
12)Allows pharmaceutical waste to be shipped by common carrier
if the generator or HGPW consolidation point meets the
following requirements:
a) The facility meets all documentation requirements in
governing the transportation and tracking required for
medical waste.
b) The waste products are transported to either a medical
waste facility, hazardous waste facilities or a reverse
distributor with the final destination of a medical or
hazardous waste facility.
13)Subjects pharmaceutical waste, HGPW consolidated by a HPGW
consolidation point and HGPW to the same documentation
requirements governing the transportation and tracking
required for medical waste.
14)Requires pharmaceutical waste transporters to maintain a
tracking document of all the waste removed for treatment and
disposal, requires a copy of the tracking documents to be
included in the pharmaceutical waste container and specifies
the requirements of the tracking documents, which include the
following:
a) The name, address and telephone number and registration
number of the generator.
b) Specific information on the pharmaceutical waste being
transported.
c) The name, address, and telephone of the person
transporting the waste.
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d) The name, address, telephone number and permit number of
the treatment facility or transfer station to which the
waste is being sent.
e) The date the waste was collected or removed from the
generator or the HGPW consolidation point.
15)Requires HGPW transporters to keep the tracking document in
his or her possession while transporting waste and to show the
document, upon demand, to any enforcement agency personnel or
Highway Patrol officer.
16)Requires medical waste treatment facilities and transfer
stations to verify the amount of the waste being delivered,
date and sign a copy of the tracking document and maintain a
copy of the tracking document for three years.
17)Specifies that single documents can be used to verify the
return of more than one container to a parent organization or
another health care facility for the purpose of consolidation
before the treatment and disposal of pharmaceutical waste over
a period of time, if the form or log is maintained in the
files of the parent organization or health care facility that
receives waste.
18)Requires pharmaceutical waste transported out of state to be
consigned to a permitted medical waste treatment in the
receiving state and specifies that if the receiving state does
not have a permitted medical waste treatment facility or the
waste crosses an international border, the waste must be
treated in accordance with state law.
19)Provides that registered medical waste facility may accept
home-generated sharps waste and HGPW under the following
conditions:
i) The generator of the waste, a member of the
generator's family or a person authorized by the
enforcement agency transports the waste to the medical
waste generator's facility.
ii) The home-generated sharps waste or HGPW is accepted
at a central location at the medical waste generator's
facility.
20)Requires medical waste treatment operators to maintain copies
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of the tracking documents received from offsite generators,
hazardous waste haulers or common carriers for three years and
report or submit, upon request, the documents to the
enforcement agency.
21) Allows the CIWMB to expend funds
from the Household Hazardous Waste Grant account in order to
make grants to local governments for the management of HGPW
and sharps waste.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. According to the Author, this measure is necessary
to make it explicit which entities may accept HGPW and
establishes requirements to ensure that the HGPW is managed
safely and appropriately. This bill is follow-up legislation
to the Author's SB 966 (Chapter 542, Statutes of 2007) which
required the CIWMB to work with stakeholders to develop model
programs for the safe, efficient take back of HGPW. The
intent of that measure was to provide a product stewardship
approach to the management of waste pharmaceuticals.
Existing law requires facilities that handle medical waste,
including waste over-the- counter and prescription drugs, to
have a full medical waste facility permit. This has been
prohibitive to those locations, such as pharmacies, who only
want to handle pharmaceutical waste from their customers as a
customer service. Traditionally medical waste is biohazardous
and infectious waste - waste that requires a high level of
treatment and oversight. The take-back of waste
pharmaceuticals is a new practice and not considered when the
permitting requirements were established.
2.Background. In 2002, the United States Geological Survey
sampled 139 streams across 30 states and found that 80 percent
had measurable concentrations of prescription and
nonprescription drugs, steroids and reproductive hormones.
Exposure to low levels of pharmaceuticals has been shown to
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have negative effects on fish and other aquatic species and
may have negative effects on human health. The Author asserts
that without a safe and effective method for disposal,
prescription drugs may be left indefinitely in medicine
cabinets where they pose a threat of potential prescription
drug misuse or abuse.
According to the Department of Toxic Substances Control (DTSC),
pharmaceuticals and personal care products (PPCPs) comprise a
diverse group of chemicals including, but not limited to,
prescription and over-the-counter human drugs, veterinary
drugs, diagnostic agents, nutritional supplements and other
consumer products such as fragrances, cosmetics and sun-screen
agents. The term PPCPs refers to the products used for
personal health or cosmetic reasons. PPCPs can be introduced
into the environment through a number of ways. The most
common source of PPCPS in the environment comes from humans
whose excretions are found in treated and untreated domestic
sewage. Other sources which can introduce PPCPs into the
environment include: leaching from landfills following
disposal of expired and unused products; disposal of expired
and unused PPCPs in the toilet; release of unabsorbed
externally applied PPCPs (e.g. lotions) to surface waters from
activities such as swimming; excreta from animals including
pets and other domestic animals; use of sewage solids and
manure for soil amendment and fertilization; and industrial
manufacturing waste streams.
Additionally, there is the potential for these compounds to pass
through sewage treatment processes intact. A 2004 USGS study
and the federal Centers for Disease Control and Prevention
(CDC) reported that, while the detected concentrations were
generally low, various organic wastewater-related contaminants
such as pharmaceuticals and their metabolites, fragrance
compounds and cosmetic compounds can remain in the water after
conventional water-treatment processes. Fish tissue data
collected in one study has shown that some PPCPs, such as
antidepressants, can accumulate in fish that live in streams
which receive a high level of treated urban effluent. In this
study, greater concentrations of the antidepressants were
observed in the brain and liver tissues than in the muscle
tissues of the fish.
3.Proper Disposal of Pharmaceuticals. According to the EPA,
sewage systems are not currently equipped for PPCP removal and
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there are no municipal sewage treatment plants that are
engineered specifically for PPCP removal or for other
unregulated contaminants. While there is no mechanism to
prevent human excrement PPCPs from entering sewage and water
systems, the federal government has issued guidelines for the
proper disposal of pharmaceuticals. A February 2007 statement
from the Office of National Drug Control Policy states that
unused, unneeded or expired prescription drugs should be taken
out of their original containers and thrown in the trash or
brought to take-back programs that allow the public to bring
unused drugs to a central location for proper disposal. The
office further states that mixing prescription drugs with an
undesirable substance, such as used coffee grounds or kitty
litter, and putting them in impermeable, non-descript
containers, such as empty cans or sealable bags, will further
ensure that the drugs are not diverted. Prescription drugs
should be flushed down the toilet only if the label or
accompanying patient information specifically instructs doing
so.
4.Statutory Barriers to HGPW Take-Back. The Medical Waste
Management Act (MWMA) currently requires HGPW to be managed as
"medical waste" which includes such material as infectious and
biohazardous waste and other types of waste that have posed a
potential harm to public health and safety and the environment
if not managed properly. The MWMA establishes rigorous
management and tracking requirements for medical waste;
including requiring the use of hazardous or medical waste
haulers and strict manifesting requirements. While this is
appropriate for large scale medical waste, the management of
HGPW needs a protective, yet different approach. Changes to
the MWMA are necessary to remove barriers to the establishment
of a network of take back opportunities for HGPW. Many
pharmacies and other retail establishments have expressed an
interest in providing collection opportunities for their
customers and while are willing and able to provide safe and
appropriate collection, they do not want to become licensed
medical waste collectors.
5.Home-Generated Sharps Waste Model. This bill uses the
approach established for the management of "sharps waste"
(e.g., needles, lancets.) generated by households that
provides an appropriate level of oversight, but acknowledges
the need to provide many options for users of sharps to
encourage their proper management and prevent illegal or
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improper disposal that leads to public health and safety and
environmental pollution problems. It establishes a wide array
of entities to, if they wish, serve as consolation points for
HGPW and creates a statutory framework for the safe
management, tracking and disposal of HGPW.
6.Efforts at the California Integrated Waste Management Board
(CIWMB). The goal of CIWMB pharmaceutical activities is to
develop model programs for rural and urban areas that meet
established statutory criteria for the collection of unused
and expired pharmaceuticals. By working with external
stakeholders to review established statutory criteria and
other essential elements for pharmaceutical collection
programs, CIWMB will be better able to craft a model program
that will fit the needs of California residents. CIWMB has
already established the Pharmaceutical Working Group (Working
Group) consisting of staff from the California Department of
Public Health, the Board of Pharmacy, Department of Toxic
Substances Control and State Water Resources Control Board. On
a national and regional level, CIWMB is also working with the
Product Stewardship Institute National Dialogue and the
California Product Stewardship Council.
7.Diversion of HGPW at Collection Site. Concerns have been
raised regarding the issue of theft of HGWP at collection
points, including pharmacies. Pharmacies have the
responsibility of keeping the drug supply safe and it is of
utmost importance that HGPW are not diverted to unauthorized
users. To ensure the safety and integrity of California's
pharmaceutical drug supply chain, it is imperative that HGPW
does not re-enter the drug supply, nor be scavenged to be sold
illegally. The Author has indicated that he is exploring ways
to address these concerns.
8.Arguments in Support. A number of organizations (listed
below) write in support for this measure because it would (1)
authorize pharmacies to accept the return of home-generated
waste; (2) allow the California Integrated Waste Management
Board to grant eligibility for local programs to prevent the
disposal of HGPW at landfills; (3) create a simple solution
that allows individuals to make a more environmentally sound
and healthy choices for drug disposal; and, (4) establish a
system, based on partnerships with state and local agencies,
retailers, suppliers and manufacturers to develop an efficient
safe and cost-effective system to manage pharmaceutical waste.
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9.Suggested Amendments. Concerns have been raised that the use
of common carriers might not be a safe option at this time
because of uncertainty related to chain of custody and related
issues. Until there is a system developed to address possible
drug diversion issues, common carriers should not be an option
for transporting pharmaceutical waste and the Author should
consider removing all common carrier references from the bill.
NOTE : Double-referral to Environmental Quality Committee
second.
SUPPORT AND OPPOSITION:
Support:
American Federation of State, County and Municipal
Employees
City of Glendora
Contra Costa Water District
East Bay Municipal Utility District
Environmental Working Group
Los Angeles County Solid Waste Management
Committee/Integrated Waste
Management Task Force
Regional Council of Rural Counties
San Luis Obispo County Integrated Waste Management
Authority
Santa Clara County Board of Supervisors
Santa Clara Valley Water District
Solid Waste Association of North America
Opposition:
None on file as of April 8th.
Consultant:Sieglinde Johnson
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