BILL ANALYSIS Ó
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Wieckowski, Chair
2015 - 2016 Regular
Bill No: AB 649
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|Author: |Patterson |
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|Version: |6/2/2015 |Hearing |6/17/2015 |
| | |Date: | |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant:|Rachel Machi Wagoner |
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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
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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;
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
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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, 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
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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 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
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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 state. SB 727 was held by the author in the Senate
Business and Professions Committee.
SOURCE: Author
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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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