BILL ANALYSIS
SB 26
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2009-2010 Regular Session
BILL NO: SB 26
AUTHOR: Simitian
AMENDED: April 15, 2009
FISCAL: Yes HEARING DATE: April 20, 2009
URGENCY: No CONSULTANT: Caroll
Mortensen
SUBJECT : HOME-GENERATED WASTE PHARMACEUTICALS
SUMMARY :
Existing law :
1)Defines home-generated sharps and allows hospitals and other
healthcare facilities to accept them from their patients.
Allows the establishment of home-generated sharps
consolidations points including pharmacies, fire stations,
and other facilities where home-generated sharps could be
collected and sent for treatment and disposal. [SB 372
(Wright) Chapter 877, Statutes of 1995]
2)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 (U.S) Postal Service. [SB 1362 (Figueroa) Chapter
157, Statutes of 2004 establishes the Safe Needle Disposal
Act of 2004]
3)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.
[SB 1305 (Figueroa) Chapter 64, Statutes of 2006]
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4)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 California State Board of Pharmacy
(CSBOP) to establish model disposal programs for waste
pharmaceuticals. [SB 966 (Simitian) Chapter 542, Statues of
2007].
5)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.
6)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) Authorizes a pharmacy to accept home-generated sharps and
pharmaceutical waste.
2) Requires the CSBOP to coordinate with other applicable
entities to develop policies to properly manage
pharmaceutical waste.
3) Establishes requirements for the management of
home-generated pharmaceutical waste that parallels that for
home-generated sharps waste.
4) Defines "Home-generated pharmaceutical waste" (HGPW) as
prescribed and over-the-counter drugs derived from a
household.
5) Removes "home-generated pharmaceutical waste" from the
definition of medical waste.
6) Defines "Pharmaceutical waste" as any pharmaceutical, as
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defined, that may no longer be sold or dispensed because it
has expired, no longer able to be used for its original
intended purpose, discarded, or consolidated at a location
approved by the enforcement agency as a HGPW consolidation
point.
7) Defines "home-generated pharmaceutical waste consolidation
point" that includes pharmacies, household hazardous waste
programs, solid waste facilities, or government offices and
establishes parameters for their operation.
8) Establishes requirements for the management of HGPW waste
including.
a) Authorizes an enforcement agency to approve a
location as a home-generated collection point.
b) Specifies other transportation and storage criteria
for the management of HGPW.
c) Establishes a tracking system for the transport of
HGPW.
9) 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.
COMMENTS :
1) Purpose of Bill . 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,
efficiently take back of HGPW. The intent of that measure
was to provide a product stewardship approach to the
management of waste pharmaceuticals.
2) Statutory Barriers to take back of HGPW . The Medical Waste
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Management Act (MWMA) currently requires HGPW to be managed
as 'medical waste' which includes such material as
infectious and biohazardous waste and other wastes that
have the potential to harm public health and safety and the
environmental 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 what commonly
comes to mind with the term 'medical waste', the management
of HGPW needs a protective, yet different approach more
conducive for the waste being managed. Changes to the
MWMA, as those reflected in this measure, 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 medical waste
collectors.
3) Management of home-generated sharps waste as a model . This
bill uses the approach established for the management of
'sharps' waste (e.g., needles, lancets.) generated by
householders that provide 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 improper disposal that
leads to public health and safety and environmental
pollution problems. It establishes a wide array of
entities to may, if they wish, to serve as consolation
points for HGPW and creates a statutory framework for the
safe management, tracking and disposal of HGPW.
4) Efforts at the 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.
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By working with external stakeholders to review established
statutory criteria and other essential elements for
pharmaceutical collection program, 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.
5) Outstanding Issues . Treatment and Shipment of HGPW:
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 up most importance that HGPW does
not pose a risk. It is imperative that HGPW does not enter
the drug supply, nor be scavenged to be sold illegally.
The author has indicated that he is exploring ways to
address these concerns. The author is also continuing to
work on a safe, efficient, and less costly return mechanism
for HWPW.
6) Chaptering Issues . This measure contains proposed changes
to code sections contained in other pending measures
including SB 700, SB 788, SB 819 and SB 821. As this bill
moves forward the author should address those conflicts.
SOURCE : Senator Simitian
SUPPORT : American Federation of State, County and
Municipal Employees (AFSCME)
California Association of Sanitation Agencies
California Product Stewardship Council
City of Sacramento
Contra Costa Water District
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East Bay Municipal Utility District (EBMUD)
Environmental Working Group
City of Glendora
Green California
Los Angeles County Solid Waste Management
Committee
Regional Council of Rural Counties
City of San Jose
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
(SWANA)
OPPOSITION : None on file