BILL ANALYSIS �
AB 333
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( Without Reference to File )
CONCURRENCE IN SENATE AMENDMENTS
AB 333 (Wieckowski)
As Amended August 22, 2014
Majority vote
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|ASSEMBLY: |67-6 |(May 23, 2013) |SENATE: |33-0 |(August 27, 2014) |
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|COMMITTEE VOTE: |6-0 |(August 29, 2014) |RECOMMENDATION: |concur |
|(E.S. & T.M.) | | | | |
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Original Committee Reference: E.S. & T.M.
SUMMARY : Makes numerous changes to the Medical Waste Management
Act (MWMA) including, among other things, codifying federal
requirements, modifying definitions, creating procedures for the
generation of medical waste from a temporary event, and modifying
contracts with medical waste transporters for the collection of
fees.
The Senate amendments :
1)Recognize that the MWMA governs medical waste management at the
facility where the waste is generated, transfer stations and
treatment facilities, and governs tracking medical waste beyond
federal transportation documentation requirements.
2)Recognize that the United States Department of Transportation (US
DOT) imposes standards for transporting medical waste on public
roads and highways while in transit, and the United States Postal
Service (USPS) imposes standards for the transportation of
medical waste through the mail.
3)Require the California Department of Public Health (CDPH) to
submit to the Legislature, by January 1, 2016, a report
describing the interaction of federal and state law for the
transport of regulated medical waste, and require CDPH to convene
a stakeholder group, including small and large quantity
generators, haulers, transfer station and treatment facility
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operators, local enforcement agencies (LEA), and retailers in its
effort to develop the report.
4)Authorize CDPH to update standards related to the transportation
of medical waste through a guidance document provided to MWMA
stakeholders and posted on CDPH's Web site, and exempt CDPH from
the Administrative Procedures Act if those standards are
consistent with the US DOT requirements.
5)Authorize CDPH to temporarily waive the state transportation
requirements in the event that a person, including CDPH, seeks a
preemption determination under federal law, and determine that
the federal requirements are the law of this state for
transporting medical waste during the temporary waiver and/or if
preemption is found.
6)Reference US DOT and USPS regulations in various provisions
related to the transport of medical waste.
7) Revise and consolidate definitions for "biohazardous waste,"
"pharmaceutical waste," "sharps waste," "trace chemotherapeutic
waste," and "trauma scene waste," under a single revised
definition for "medical waste."
8) Revise additional various definitions used throughout the
MWMA, including:
a) The definition of "biohazard bag" and specify color coding
requirements for the purpose of segregating waste;
b) The definition of "highly communicable diseases" to update
categorization to reference the appropriate Centers for
Disease Control and Prevention risk group;
c) The definition of "medical waste treatment facility" to
specify over which land the facility has control;
d) The definition of "pharmaceutical" to reference the
Department of Toxic Substances Control's authority over
hazardous waste;
e) The definition of "sharps container" to specify that trace
chemotherapeutic wastes are not required to be lined with a
plastic liner; and,
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f) The definition of "transfer station" to clarify defined
locations are permitted by CDPH.
9)Clarify the reference to existing law for treating medical waste
as permitted by an LEA.
10)Require small quantity generators (SQG) to include additional
information in the medical waste management plan ("plan"),
including:
a) Steps taken to categorize generated pharmaceutical waste
and how those wastes are disposed; and,
b) A closure plan for the termination of the treatment
facility.
11)Require registered medical waste generators to additionally
provide to LEA shipping documents of all untreated medical waste
shipped offsite.
12)Delete requirements for medical waste generators to apply for a
limited quantity hauling exemption, and authorize SQGs and large
quantity generators (LQG) to transport limited quantities of
medical waste up to 35.2 pounds to the central location of
accumulation as long as specific conditions are met, including
that the transport is in accordance with the requirements of the
US DOT Material of Trade Exception, and the person transporting
medical waste provides a log to the receiving facility with
specified information.
13)Reference the applicable transportation requirements for
transporting medical waste from adjacent properties.
14)Require LQGs to include additional information in the plan,
including:
a) Steps taken to categorize generated pharmaceutical waste
and how those wastes are disposed; and,
b) A closure plan for the termination of the treatment
facility.
15)Require medical waste generators to update their plan within 30
days from when any relevant information in the plan changes, and
require the plan be maintained on file for review.
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16)Clarify further that "medical waste" does not include waste
generated in biotechnology that does not contain a highly
communicable disease.
17)Authorize registered LQGs to generate medical waste at temporary
events, and require LQGs to notify LEA within 72 hours of an
event, unless the sponsor of the temporary event previously
notified the LEA of the event.
18)Authorize SQGs to generate medical waste at temporary events,
and require SQGs to notify LEA within 72 hours of event, unless
the sponsor of the temporary event previously notified the LEA of
the event.
19)Increase the percentage of administrative fee medical waste
transporters may retain from 5% to 7.5% to cover administrative
costs.
20)Limit administrative fees paid by medical waste generators to be
paid no more than once per year.
21)Require operators of onsite sterilization equipment used at SQGs
to receive annual training that complies with federal
Occupational Safety and Health Administration (OSHA) standards
and records of training to be maintained for two years.
22)Require LQGs to annually train operators of onsite sterilization
equipment consistent with federal OSHA standards, and records of
training to be maintained for two years.
23)Require medical waste transported out of state to be consigned
to a permitted medical waste treatment facility out of state and
refer to state law for treating medical waste crossing an
international border.
24)Authorize solid waste facility operators to arrange for proper
treatment and disposal of erroneously disposed medical waste at a
solid waste facility.
25)Require a person applying for a permit for an offsite medical
waste treatment facility to additionally include information
regarding a plan for closure describing decontamination methods.
26)Clarify that heat sensitive tape or another acceptable method
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only need to be placed on liner bags when biohazard bags or
sharps containers are contained in a larger lined bag for
autoclave treatment.
27)Require human anatomical parts, excluding teeth, to be disposed
of by interment, incineration, or appropriate alternative
treatment technologies.
28)Specify that the containerization and storage requirements
currently in the MWMA only apply at the point of generation and
when the waste is collected in the room.
29)Specify additional labeling and containerization requirements.
30)Revise the usage of biohazardous bags in certain health care
settings, establish weight limits for medical waste placed in
biohazardous bags at three pounds or one gallon, and change the
biohazardous waste storage requirements at transfer stations.
31)Delete outdated implementation and sunset dates.
32)Delete confusing statutory cross-references.
AS PASSED BY THE ASSEMBLY , this bill made technical and conforming
changes to the MWMA. Specifically, this bill:
1) Deleted the existing definition of "biohazard bag," and
instead replaced it with the definition in the Code of Federal
Regulations.
2) Amended the definition of "medical waste management plan" to
specify that the document that is completed by generators of
medical waste describes how the medical waste generated at
their facility shall be segregated, handled, stored, packaged,
treated, or shipped for treatment, as applicable. Specified
that the medical waste management plan is to be completed on
forms prepared by the enforcement agency, only if those forms
are provided by the enforcement agency.
3) Required a solid waste transporter who discovers that he or
she has (unknowingly) hauled untreated medical waste to a
landfill or materials recovery facility to contact the
originating generator of the medical waste to respond to the
landfill or recovery facility to provide ultimate proper
disposal of the medical waste.
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4) Clarified that the statutory requirements for treatment of
carcasses of animals that die of infectious diseases includes
those that are euthanized because they are suspected of having
been exposed to infectious disease.
FISCAL EFFECT : According to the Senate Appropriations Committee:
1)Initial costs of $156,000 annually from the Medical Waste
Management Fund for fiscal year (FY) 2015-16 and FY 2016-17 to
assist with compliance with the changes to the MWMA.
2)Minor revenue losses to the Medical Waste Management Fund by
allowing medical waste transporters to keep an additional 2.5% of
the small generator annual fee for administrative costs.
COMMENTS :
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 can contain pathogens, blood, low
levels of radioactivity, discarded needles, syringes, scalpels,
expired drugs and vaccines, which can pose a hidden risk of
infection, radioactivity exposure, and needle-stick injuries.
Medical Waste Management Act: The MWMA was created in response to
several incidents of medical waste washing up on San Diego County
beaches, as well as several reports of medical waste being disposed
of in dumpsters and trash bins. AB 109 (Hayden), Chapter 1613,
Statutes of 1990, and AB 1641 (Mojonnier), Chapter 1614, Statutes
of 1990, were ultimately combined to form the MWMA to, according to
the original Legislative intent, "comprise a single, integrated,
and complementary approach to the storage, treatment,
transportation, and disposal of medical waste."
The MWMA allows any local ordinance regulating infectious waste
that was in existence before 1990 and regulated both large and
small quantity generators to continue.
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Enforcement, by the numbers: The MWMA allows local governments to
elect to be the enforcement agency of the MWMA and to assess
appropriate fees for their enforcement activities. Currently, CDPH
is the enforcement authority for 25 counties, and as part of those
duties issues permits to generators in those counties. CDPH also
issues permits to transfer stations. Under CDPH's jurisdiction,
there are:
1)118 transfer stations in California.
2)Roughly 6,500 SQGs registered with CDPH (defined as generating
less than 200 pounds per month of medical waste). These can be
doctor's offices, veterinary offices, dental offices,
laboratories, research labs, and pharmacies.
3)Approximately 800 LQGs registered with CDPH. These are typically
hospitals, skilled nursing facilities, psychiatric facilities,
veterinary hospitals, or any of the examples above.
Data is not maintained for the number of small and large quantity
generators in the counties that serve as their own enforcement
agencies and issue permits for the generators in their counties.
Purpose for reform: According to the author, "[t]he Medical Waste
Management Act was signed in to law in 1990 by Governor George
Deukmejian. The MWMA made California one of the leading states in
the nation in governing this waste stream. Many changes during the
intervening 23 years in medical waste treatment, transportation
oversight, and new requirements by landfill and waste water
treatment operators regarding acceptance of portions of this waste
stream necessitate an update of the Act.
"Since enactment of the Medical Waste Management Act (MWMA), the
federal Department of Transportation (DOT) has increased its
regulatory oversight of transportation of medical waste which
preempts state law. Similarly, the United States Postal Service
(USPS) requirements for the mail back of medical waste also preempt
state law. When the Act was initially implemented it was common
practice to dispose of pharmaceutical wastes into landfills or
through sewer systems. Heightened regulation of receiving waters
of waste water treatment plants and the potential of runoff from
landfills has resulted in these facilities tightening requirements
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for acceptance of pharmaceutical wastes for disposal.
"The current Medical Waste Management Act (Sections 117600-118360
Health & Safety Code) was implemented in 1991 and federal agencies
(Department of Transportation and US Postal Service) now regulate
transportation of medical waste and pre-empt the state
requirements. This creates conflict for California healthcare
facilities and places them at risk of non-compliance with federal
statutes. Administrative solutions cannot fix the problem as there
is a conflict in the statutes governing medical waste treatment and
transportation."
Clarifying the role of federal requirements: Since this bill was
amended to recognize the US DOT and USPS's requirements for
transporting medical waste, confusion between stakeholders and CDPH
has lingered over where federal law preempts state law, and where
state law is permitted to be enforced over federal law.
Supporters contend that clarification in the MWMA over which laws
govern the transportation of medical waste - federal or state -
will remove confusion from the industry over compliance
requirements, and reduce risk for non-compliance with federal
requirements.
As reflected in the current version of this bill, negotiations have
achieved consensus between stakeholders and CDPH on addressing the
blurred lines between state and federal laws. This bill requires
CDPH, in coordination with MWMA stakeholders, to develop a report
regarding the implementation and interaction of federal and state
law for the transport of regulated medical waste, and to provide
that report to the legislature by January 1, 2016.
While differences of opinion may remain on state versus federal
authority for transporting regulated medical waste, this bill gives
MWMA stakeholders clearer guidance on which rules to follow and
which documentation forms to submit and maintain, and gives CDPH
time to identify precise state jurisdiction and federal preemption
where ambiguities from a regulator's perspective may remain.
Substantial amendments in the Senate: While the subject matter of
this bill is the same as was passed by the Assembly, the bill was
substantially amended in the Senate to update and revise the MWMA.
Analysis prepared by : Paige Brokaw / E.S. & T.M. / (916)
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