BILL ANALYSIS �
Senate Appropriations Committee Fiscal Summary
Senator Kevin de Le�n, Chair
SB 1014 (Jackson) - Pharmaceutical waste: home generated.
Amended: April 21, 2014 Policy Vote: EQ 6-0, BP&ED 6-0
Urgency: No Mandate: Yes (see staff comment)
Hearing Date: May 12, 2014 Consultant: Marie Liu
This bill meets the criteria for referral to the Suspense File.
Bill Summary: SB 1014 would require the Department of Resources
Recycling and Recovery (CalRecycle) to develop regulations for
programs that collect and dispose of home-generated
pharmaceutical waste (HGPW). This bill would declare that a
collection program in compliance with these regulations would be
considered in compliance with all state laws and regulations
concerning the handling, management, and disposal of HGPW.
Fiscal Impact:
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.
Background: SB 966 (Simitian) Chapter 542, Statutes of 2007
required the California Integrated Waste Management Board (now
CalRecycle) to develop model programs for the collection from
consumers and proper disposal of unused or expired
home-generated pharmaceuticals. The model programs needed to
meet specific requirements including no cost to the consumer,
protection of public health and safety, protection of health and
safety of consumers and employees, and protection against the
diversion of drug waste for unlawful use or sale. The model
programs also met minimum criteria developed by the
Pharmaceutical Working Group (comprised of staff from the
CalRecycle, DPH, Board of Pharmacy, Department of Toxic
Substances Control, and the State Water Resources Control
Board).
The Medical Waste Management Act (HSC �106500 et seq.) requires
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the Department of Public Health (DPH) to regulate the management
and handling of medical waste. This act defines
"pharmaceuticals" as prescription or over-the-counter human or
veterinary drug, excluding any pharmaceutical that is regulated
as a controlled substance under federal law or as a radioactive
material under the California's Radiation Control law.
"Pharmaceutical waste" is defined as a pharmaceutical that may
no longer be sold or dispensed for use as a drug, excluding
pharmaceuticals that still have potential value to the
generator. Waste that is comprised only of pharmaceuticals is
considered "medical waste," which is required to be transported
to an offsite medical waste treatment facility.
Proposed Law: This bill would require CalRecyle to adopt
regulations regarding the collection and disposal of
home-generated pharmaceutical waste (HGPW), which must be based
on the model programs developed pursuant to SB 966 and must
contain minimum content including, among other things, the
following:
Reporting requirements to CalRecycle to enable the department
to evaluate safety, efficiency, effectiveness, and funding
sustainability;
Notification and education materials for consumers;
Requirements for obtaining local or state permits;
Requirements for 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; and
Requirements for the one-time or periodic collection events.
CalRecycle would be permitted to revise the regulations if it
deems it necessary and only if the revision provides an
equivalent or greater level of safety.
Any entity that elects to implement a HGPW program would be
required to comply with the regulations. Programs that are in
compliance with these regulations would be considered in
compliance with all state laws and regulation concerning the
handling, management, and disposal of HGPW.
This bill would also authorize a pharmacy to accept the return
of HGPW.
This bill would define "home-generated pharmaceutical waste" and
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would exclude HGPW from the definition of "medical waste."
Related Legislation: AB 333 (Wieckowski) - makes various changes
to the Medical Waste Management Act. (In the Senate
Environmental Quality Committee)
AB 467 (Stone) Chapter 10, Statutes of 2014 - creates a
licensure category for a surplus medication collection and
distribution intermediary.
AB 1727 (Rodriguez) would restrict certain pharmaceuticals from
county operated prescription drug collection and redistribution
programs. (In Assembly Health Committee)
SB 727 (Jackson) - would have created the Drug Abuse Prevention
and Safe Disposal Program Stewardship Program within CalRecycle.
(Held in Senate Environmental Quality)
Staff Comments: This bill would require CalRecycle to adopt
regulations for the collection and disposal of HGPW. CalRecycle
estimates that the cost of developing these regulations would be
between $250,000 and $300,000.
This bill would require the regulations to mandate reporting to
CalRecycle to enable the department to evaluate the "safety,
efficiency, effectiveness, and funding sustainability" of the
program. CalRecycle anticipates that it would need to develop a
database and to dedicate staff time to analyze the reports.
These costs would depend on the number of HGPW collection
programs that are established, but are likely to be between
$50,000 and $150,000 annually. Staff further notes that since
these programs are voluntary and would be operated by local
agencies or private entities, it may not be necessary (or
potentially appropriate) for CalRecycle to be evaluating a
program's funding sustainability. Also, while the bill states
the intended purpose of the reporting, staff notes that the bill
does not require CalRecycle to do such an analysis, or report
its results to any other entity.
Staff notes that there are a number of unclear requirements in
the bill, such as the requirement for the state regulations to
create requirements for obtaining local permits and restrictions
on the regulation revisions. Additionally, the bill currently
requires that any HGPW program is compliant with the regulations
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developed pursuant to this bill, which according to the author,
is not her intent. Instead, the author only intends that the
compliance with the HGPW regulations be voluntary, but if the
program does follow the regulations, then the program would be
deemed in compliance with all state laws and regulations
concerning the handing, management, and disposal of HGPW. The
author has informed committee staff of her intention to amend
the bill to properly reflect this intention and to address the
unclear requirements in the bill.
This bill is marked as a state-mandated local program because it
creates a new crime. However, this mandate is not reimbursable.