BILL ANALYSIS Ó
AB 649
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Date of Hearing: April 14, 2015
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Alejo, Chair
AB
649 (Patterson) - As Introduced February 24, 2015
SUBJECT: Medical waste: law enforcement drug takeback programs
SUMMARY: Authorizes law enforcement agencies to use
prescription drug incinerators not in compliance with various
state laws up to four times. Specifically, this bill:
Amends the Medical Waste Management Act (MWMA) to allow a law
enforcement agency that operates a prescription drug takeback
program to utilize up to four times per year a prescription drug
incinerator that does not comply with the requirements of the
MWMA or other state laws if the incinerator was purchased prior
to January 1, 2018.
EXISTING LAW:
1) Exempts household pharmaceutical waste from hazardous
waste classifications (40 CFR 261.4(b)) and as medical
waste. (Health and Safety Code (H&S) § 117700)
2) Pursuant to the MWMA, requires the California Department
of Public Health (CDPH) 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
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local agencies have elected not to conduct their own
enforcement. (H&S § 117600, et seq.)
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. (H&S § 117690 and § 117747)
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 CDPH which provides complete combustion of the
waste into carbonized or mineralized ash;
b. Treatment with an alternative technology
approved by CDPH 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 CDPH and result in the
destruction of pathogenic micro-organisms. (H&S §
118215(a))
5) Requires any alternative medical waste treatment method
to be evaluated by CDPH and either approved or rejected
pursuant to specified statutory criteria. (H&S § 118215
(a)(1)(B))
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. (H&S § 117900)
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7) Requires pharmaceutical takeback programs to be in
compliance with the Controlled Substances Act and its
implementing regulations. (21 U.S.C. § 801-971 and 21 CFR
1300-1321)
8) Regulates air emissions from stationary and mobile
sources pursuant to the Federal Clean Air Act. (42 U.S.C.
§7401 et seq.)
9) Establishes the California Air Resources Control Board
to enforce the Federal Clean Air Act. (H&S 39500 § et seq.)
FISCAL EFFECT: Unknown.
COMMENTS:
Purpose for reform: 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."
What is medical waste?: Medical waste is waste materials
generated at health care facilities, such as hospitals, clinics,
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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)).
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 percent 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
2011-2012; 1,918 pounds in Fiscal Year 2012-2013; and 2,457
pounds in Fiscal Year 2013-2014. 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.
Pharmaceutical waste treatment: Under current law,
pharmaceutical waste can be treated in one of several ways,
including:
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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.
What does this bill authorize, exactly?: The bill would allow a
law enforcement agency that operates a prescription drug
takeback program to use a prescription drug incinerator that
does not comply with the requirements of the MWMA or other state
laws if the incinerator was purchased prior to January 1, 2018.
The United States Environmental Protection Agency (US EPA), in a
September 2012 guidance letter on the disposal of household
pharmaceuticals collected by takeback programs, recommended that
pharmaceutical waste be sent to a permitted hazardous waste
combustor, and, when that is not feasible, be sent to a large or
small municipal combustor. The US EPA specifically states,
"after pharmaceuticals are collected from ultimate users in a
takeback event, they must be disposed of in accordance with
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federal, state and/or local environmental regulations."
The US EPA also acknowledges that it does "not want
[incineration] costs to discourage takeback events", and
subsequently recommended incineration facilities that meet the
US EPA's Large Municipal Waste Combustor (LMWC) Standards and
Small Municipal Waste Combustor (SMWC) Standards (40 CFR parts
62 and 60) when hazardous waste combustion is not feasible.
According to the author, law enforcement personnel
administrating takeback programs are currently hauling or
shipping their wastes to one of three federally compliant LMWC
or SMWC, of which there are three in California:
Commerce Refuse-to-Energy Facility (Commerce)
Southeast Resource Recovery Facility (Long Beach)
Stanislaus County Resource Recovery Facility (Crow's
Landing)
None of these facilities, however, are permitted under the MWMA
to treat pharmaceutical waste.
Therefore, this bill would authorize a broader scope of options
for pharmaceutical incineration. The bill does not contain a
definition for "prescription drug incinerator," so the bill
could potentially apply to any incinerator that is or could be
permitted to take prescription drugs.
One cited example of a noncompliant incinerator this bill could
authorize is the "Drug Terminator", which is described as a wood
or charcoal fired incinerator that uses two high velocity
electric blowers that create a cyclone of intense heat, and
render the volume of material as solid waste.
The MWMA requires incineration to be done at a "permitted
medical waste treatment facility in a controlled-air,
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multi-chamber incinerator, or other method of incineration
approved by the Department." It's not yet determined if the
"Drug Terminator" would qualify as an acceptable treatment
method in California, but under current law, it is eligible to
be considered as an alternative medical waste treatment method.
(H&S § 118215 (a)(3)(A))
Managing pharmaceutical waste: Pharmaceutical waste is
segregated into three different categories for proper treatment:
controlled, hazardous, and non-hazardous.
Drugs and other substances that are considered controlled
substances under the federal Controlled Substances Act (CSA) are
categorized based on whether they have a currently accepted
medical use in treatment in the United States, their relative
abuse potential, and likelihood of causing dependence when
abused. These pharmaceuticals are managed differently than
hazardous and non-hazardous pharmaceuticals; controlled
substances must be disposed of in a manner that renders them
non-retrievable in accordance with federal regulations, unlike
the other categories of pharmaceutical waste.
The Drug Enforcement Administration (DEA) hosts National
Prescription Drug Takeback Days to provide opportunity for
disposing controlled substances. To date, the DEA has held 9
takeback days, with the most recent event held in September
2014. The DEA initiated these takeback days four years ago
because at that time the CSA made no legal provision for people
to dispose of unwanted controlled substance prescription drugs
except to give them to law enforcement, and the CSA banned
pharmacies and hospitals from accepting them.
Since the DEA's first Takeback Day, the DEA has developed
regulations that outline methods the public can use to transfer
pharmaceutical controlled substances and other prescription
drugs to authorized collectors for the purpose of disposal.
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The DEA has announced it plans to cease holding its takeback
days because the new disposal regulations are registered and in
effect for disposing controlled substances. According to the
DEA, law enforcement continues to have autonomy with respect to
how they collect controlled substance prescription drugs,
including holding takeback events. Any person or entity-DEA
registrant or non-registrant-may partner with law enforcement to
conduct takeback events.
Alternatives for managing pharmaceutical waste over the status
quo: There are registered medical waste haulers in California
that pick up medical waste and transport to permitted medical
waste treatment facilities. There are currently 125 medical
waste transporters registered under the MWMA. In addition, there
are numerous transfer stations in California that are part of
the medical waste disposal chain. These transfer stations serve
as the collection and consolidation points for all types of
medical waste. The waste is further segregated at this point
and shipped to the proper treatment facilities (either in or out
of state).
Registered haulers can pick up and transport hazardous and
non-hazardous pharamcetuicals wastes. According to one
registered medical waste hauler, average costs to provide
pharmaceutical waste pick-up services to a law enforcement
agency would range from $60-$110/hour for a pharmaceutical
technician to sort through the collected pharmaceuticals and
segregate categorically for disposal, and then $1-$3/pound for
disposal.
Depending on law enforcement agencies' current costs, they could
consider the costs to hire a registered medical waste hauler to
periodically pick up the agency's collected pharmaceuticals
versus shipping or transporting their collected pharmaceutical
wastes themselves. While potentially more expensive, this
alternative to managing pharmaceutical waste may be more
advantageous from a public health perspective than changing
state law to allow noncompliant incinerators.
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Proposed amendments: As written, the bill may be overly broad in
allowing incinerators that don't comply with various
environmental protection and medical waste management laws. To
maintain the author's intent to authorize more in-state options
for treating pharmaceutical waste, and to ensure pharmaceutical
wastes are appropriately destroyed, the committee may wish to
consider the following amendments:
1. Striking lines 1-2 on page 2 in reference to
noncompliant incinerators, and replacing with language
authorizing CDPH to approve and permit under the MWMA
prescription drug incinerators designed to treat
pharmaceutical waste as an alternative medical waste
treatment method; and
2. Amending the MWMA to authorize CDPH to permit
prescription drug incinerators that are specifically
designed to solely treat pharmaceutical wastes and that
meet any necessary requirements for safely treating those
wastes.
Related legislation:
AB 45 (Mullin), pending before the Assembly Local Government
Committee, would establish household hazardous waste collection
programs and would include collection of household generated
pharmaceutical waste.
REGISTERED SUPPORT / OPPOSITION:
Support
California Health Collaborative
California State Sheriff's Association
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Fresno County Department of Behavioral Health
Opposition
None on file.
Analysis Prepared
by: Paige Brokaw / E.S. & T.M. / (916) 319-3965