BILL ANALYSIS �
AB 333
Page 1
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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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 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 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 website,
and exempt CDPH from the Administrative Procedures Act if
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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,
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"),
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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 federal 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.
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
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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 only need to be placed on liner bags when biohazard
bags or sharps containers are contained in a larger lined
bag for autoclave treatment.
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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.
EXISTING LAW :
1) Authorizes the US DOT to enforce rules on the
transportation of medical waste on public roads and highways
(Title 49 United States (U.S.) Code of Federal Regulations).
2) Authorizes a person, including a state or Indian tribe,
directly affected by a requirement of a state to apply to
the Secretary of the US DOT for a decision on whether the
requirement is preempted by the federal regulations pursuant
to Title 49 (Section 5125 (d) of Title 49 U.S. Code of
Federal Regulations).
3) Authorizes the USPS to regulate medical waste and sharps
waste containers that are transported through the mail
(Domestic Mail Manual 601.10.17.5).
4) Pursuant to the MWMA, requires 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 local agencies have elected not to
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conduct their own enforcement (Health and Safety Code
Sections 117600, et seq.).
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.
Specifies 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.
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, enactment of [a prior version of] this bill would
likely result in costs of $340,000 annually from the Medical
Waste Management Fund (special) for Fiscal Year (FY) 2015-16 and
FY 2016-17 to assist with compliance with the changes to the
MWMA. Initial costs of $166,000 for FY 2015-16 and FY 2016-17,
then $145,000 thereafter from the Medical Waste Management Fund
to CDPH to review and approve treatment technologies. Minor
revenue losses to the Medical Waste Management Fund (special)
by allowing medical waste transporters to keep an additional
2.5% of the small generator annual fee for administrative costs.
Unknown, possibly minor, cost pressures to the Medical Waste
Management Fund (special) by deleting the ability for CDPH to
adjust multiple fees through regulation. That analysis does not
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reflect the current version of this bill.
COMMENTS :
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.
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, 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.
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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 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
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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.
Analysis prepared by : Paige Brokaw / E.S. & T.M. / (916)
319-3965
FN: 0005503