SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Wieckowski, Chair
2015 - 2016 Regular
Bill No:
Author:
Version:
Urgency:
Consultant:
AB 649
Patterson
6/2/2015
No
Rachel Machi Wagoner
Hearing Date: 6/17/2015
Yes
Fiscal:
SUBJECT: Medical waste: law enforcement drug takeback programs.
ANALYSIS:
Existing law:
1) Exempts household pharmaceutical waste from hazardous waste
classifications (40 CFR 261.4(b)) and as medical waste. (Health and Safety
Code §117700)
2) Pursuant to the Medical Waste Management Act (MWMA), requires the
California Department of Public Health (DPH) to regulate the management
and handling of medical waste and authorizes off-site medical waste treatment
facilities, oversees transfer stations, approves alternative treatment
technologies, and acts as the local enforcement agency in 25 jurisdictions
where local agencies have elected not to conduct their own enforcement.
3) Defines "medical waste" to include, among other things, pharmaceutical
waste, which includes a prescription or over-the-counter human or veterinary
drug, including, but not limited to, a drug as defined in the Federal Food,
Drug, and Cosmetic Act.
4) Requires a person that generates or treats medical waste to ensure that the
medical waste is treated by one of the following methods rendering it solid
waste:
a) Incineration at a permitted medical waste treatment facility in a
controlled-air, multichamber incinerator, or other method of
incineration approved by DPH which provides complete combustion of
the waste into carbonized or mineralized ash;
b) Treatment with an alternative technology approved by DPH that treats
the waste with temperatures in excess of 1300 degrees Fahrenheit;
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c) Steam sterilization at a permitted medical waste treatment facility or by
other sterilization, in accordance with specified operating procedures
for steam sterilizers or other sterilization; or,
d) Other alternative medical waste treatment methods which are approved
by DPH and result in the destruction of pathogenic micro-organisms.
5) Requires any alternative medical waste treatment method to be evaluated by
DPH and either approved or rejected pursuant to specified statutory criteria.
6) Prohibits a person from hauling medical waste unless the person is a
registered hazardous waste hauler; a mail-back system approved by the United
States Postal Service; a common carrier allowed to haul pharmaceutical waste;
a small- or large-quantity generator transporting limited quantities of medical
waste with an exemption; or a registered trauma scene waste practitioner.
7) Requires pharmaceutical takeback programs to be in compliance with the
Controlled Substances Act and its implementing regulations.
8) Regulates air emissions from stationary and mobile sources pursuant to the
Federal Clean Air Act.
9) Establishes the California Air Resources Control Board to enforce the Federal
Clean Air Act.
This bill:
Allows law enforcement agencies to use approved prescription drug incinerators up
to four times per year to treat and dispose of medical waste as specified.
Specifically:
1) Amends the MWMA to require any alternative medical waste treatment designed
to treat pharmaceutical waste, including a pharmaceutical incinerator, to be
evaluated and approved by the Department of Public Health (DPH).
2) Allows a law enforcement agency that operates a prescription drug takeback
program to use an approved pharmaceutical incinerator up to four times per year.
Background
1) What is medical waste?: Medical waste is waste materials generated at health
care facilities, such as hospitals, clinics, physician's offices, dental practices,
blood banks, and veterinary hospitals/clinics, as well as medical research
facilities and laboratories. Medical waste includes pharmaceutical waste,
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including prescription or over-the-counter human or veterinary drugs.
Pharmaceuticals were added as covered wastes under the MWMA to transfer
management of this waste from the California Department of Toxic Substances
Control to the Department of Healthcare Services (now CDPH) in 1996 (SB
1966, Statutes of 1996, Chapter 536).
2) Pharmaceutical takeback programs: According to the U.S. Centers for Medicare
& Medicaid Services, approximately $275.9 billion in prescription drugs were
predicted to be prescribed in the U.S. in 2014. By 2020, that number is projected
to reach $379.9 billion. An estimated 10 to 33% of prescribed medicines are not
consumed. With a lack of safe, secure and convenient disposal options,
consumers traditionally turn to trashing, flushing or storing these medicines at
home.
Over the past several years, Fresno County's takeback program has seen an
exponential increase in drug drops offs: the County collected 755 pounds of
prescription drugs in Fiscal Year 2011-12; 1,918 pounds in Fiscal Year 2012-13;
and 2,457 pounds in Fiscal Year 2013-14. This evidences a growing demand for
maintaining a convenient drug takeback program.
Law enforcement-operated takeback systems offer a safe and convenient way for
residents to appropriately dispose their expired and unused pharmaceuticals in
lieu of flushing or throwing those drugs in the trash can, which is known to
cause deleterious impacts to water quality and public health.
3) Pharmaceutical waste treatment: Under current law, pharmaceutical waste can
be treated in one of several ways, including:
 Incineration at a permitted medical waste treatment facility;
 Alternative treatment methods that treat the waste with temperatures in excess
of 1300 degrees Fahrenheit;
 Steam sterilization at a permitted medical waste treatment facility; or
 Other alternative medical waste treatment methods which are approved by
CDPH.
Under the MWMA, pharmaceutical waste must be incinerated and, according to
CDPH, there are no permitted incinerators in California for the treatment of that
type of medical waste. (The last medical waste incinerator that was in operation
in the state (Integrated Environmental Systems in Oakland) was closed in 2001.)
At this time, all pharmaceutical waste generated from hospitals, pharmacies,
retailers, or other generators is shipped by a registered medical waste hauler out
of state for treatment. Permitted in-state facilities treat biohazardous and sharps
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waste through steam sterilization (autoclaving) or by an approved alternative
treatment technology.
Comments
1) Purpose of Bill. According to the author, no permitted medical waste
incinerators exist in California, and states, "[w]ith limited options for disposal of
these collected pharmaceuticals, law enforcement agencies that operate these
takeback programs often resort to expensive methods such as shipping the
materials out of state or taking police officers off the street to drive long
distances to one of the three California locations where this incineration is
permitted.
“AB 649 would permit law enforcement agencies that operate a prescription drug
takeback program to use a noncompliant prescription drug incinerator to dispose
of the pharmaceuticals they collect from the community.”
2) Amendment needed.
a. Required approval. Amendments added in the June 2, 2015 version of
AB 649 state, “By June 1, 2017, the department shall complete the first
evaluation and approval of these alternative medical waste treatments,
including a pharmaceutical incinerator.” By requiring approval, this
language assumes that this technology will meet DPH requirements for
public health and environmental safety. An amendment is needed to
strike “approval” from this language.
b. Compliance with air quality regulation. While nothing in this
legislation provides an exemption from local air quality law or other
environmental statute, because this bill amends MWMA, an
amendment should be added to clarify that any alternative medical
waste treatment evaluated pursuant to this chapter must still meet
requirements pursuant to other environmental protection laws.
Related/Prior Legislation
SB 727 (Jackson, 2014) would have: 1) required a producer of a pharmaceutical sold
in the state to, individually or through a stewardship organization, to submit a plan,
on or before January 1, 2015, to the Department of Resources Recycling and
Recovery and 2) required the plan to provide for the development of a program to
collect, transport, and process home-generated pharmaceutical drugs and to include
specified aspects, including the minimum amount of collection sites, including by
January 1, 2016, at least one collection service within 10 miles per person in the
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state. SB 727 was held by the author in the Senate Business and Professions
Committee.
SOURCE:
Author
SUPPORT:
California Health Collaborative
California Police Chiefs Association
California State Sheriff's Association
City of Fresno Police Department
City of Reedley, Police Department
City of Sanger, Police Department
Fresno County Department of Behavioral Health
Valley Children’s Healthcare
OPPOSITION:
None received
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