BILL ANALYSIS �
AB 333
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Jerry Hill, Chair
2013-2014 Regular Session
BILL NO: AB 333
AUTHOR: Wieckowski
AMENDED: June 4, 2014
FISCAL: Yes HEARING DATE: June 18, 2014
URGENCY: No CONSULTANT: Karen Morrison
SUBJECT : MEDICAL WASTE MANAGEMENT ACT
SUMMARY :
Existing federal law :
1) Authorizes the United States Department of Transportation (DOT)
to enforce rules on the transportation of medical waste on
public roads and highways (49 CFR).
2) Authorizes the United States Postal Service (USPS) to regulate
medical waste and sharps waste containers that are transported
through the mail (Domestic Mail Manual 601.10.17.5).
Existing state law :
1) Under the Medical Waste Management Act (MWMA, or Act), requires
the California Department of Public Health (DPH) to regulate the
management and handling of medical waste. The program
authorizes off-site medical waste treatment facilities, oversees
transfer stations, approves alternative treatment technologies,
and acts as the local enforcement agency in 26 jurisdictions
(including Los Angeles County) where local agencies have elected
not to conduct their own enforcement.
This bill would change the MWMA in the following ways :
1) The MWMA currently specifies regulations for the transportation
of medical waste.
a) The bill codifies the federal preemptions and requirements
under DOT and USPS for the transportation and tracking of
medical waste. (��117605, 117900, 117904, 118000, 118025,
AB 333
Page 2
118029, and 118040)
b) The bill requires the use of a "shipping document," which
is used by DOT and USPS, rather than a "tracking document."
c) The bill specifies that when medical waste is transported
out of state, if there is no permitted medical waste
treatment facility in the receiving state or if the waste
crosses an international border, then the waste must be
treated as specified in the MWMA prior to leaving the state.
d) Requires that records be kept for only two years, rather
than three.
2) The MWMA defines numerous terms for the purposes of managing
medical waste.
a) The bill amends several definitions in the MWMA.
b) The bill replaces the definition of "health care
professional," which is currently based on licensure or
certification, to more broadly include any person who
generates medical waste in a health care setting or in the
course of providing a health care service. (�117662)
c) The bill consolidates all of the subcategories of medical
waste into one definition. The definition of medical waste
also includes animal specimens infected with pathogens known
to be infectious to humans. Finally, the definition limits
"sharps waste" to devices contaminated with biohazardous
waste. (�117690)
d) The bill narrows the definition of "medical waste
treatment facility" from all adjacent land and structures to
land under the control of the treatment facility. (�117725)
e) The bill expands the definition of "treatment" to specify
the purpose of treatment for each subset of medical waste.
(�117780)
3) The MWMA currently does not have explicit language on the
AB 333
Page 3
procedure for the generation of medical waste at a temporary
event.
a) The bill requires large quantity generators (LQGs) to
notify a local enforcement agency (LEA) of their intended
participation in a temporary event that may generate medical
waste. (�117890)
4) The MWMA allows DPH to contract with medical waste transporters
or providers of mail-back systems to collect fees for medical
waste registration, and allows those transporters to keep up to
5% of the fees to cover administrative costs. (�117924)
a) The bill increases the fee to 7.5% and removes the
provision allowing providers of mail-back systems to collect
fees.
b) The bill also stipulates that this fee can only be
collected once annually.
5) The MWMA requires small quantity generators (SQGs) and LQGs to
register with LEAs and to provide their medical waste management
plan on forms provided by the department. (��117935 and 117960)
a) The bill removes the requirement for the format of the
medical waste management plan.
b) The bill requires, among other changes, a closure plan for
the termination of treatment at the facility in the medical
waste management plan.
6) The MWMA does not detail the training requirements for
individuals who treat medical waste at an SQG or LQG.
a) The bill specifies that operators who use onsite treatment
technologies receive annual training on the operation of
equipment, the use of personal protective equipment, the
procedure to clean up spills, and any other required
information. (��117938 and 117967)
AB 333
Page 4
7) The MWMA provides a limited quantity exception for home health
care providers to allow them to transport fewer than 20 pounds
of medical waste. (�118030)
a) The bill removes this exception in favor of the federal
Materials of Trade (MOT) exception, and provides
authorization for home health care providers under the
registration of SQGs and LQGs. (��117946 and 117976)
8) The MWMA exempts a person who unknowingly transports medical
waste to a solid waste facility from the Act. (�118027)
a) The bill requires a solid waste transporter who discovers
that untreated medical waste has been hauled to a solid waste
facility to contact the original generator. The generator
must provide for ultimate disposal of the waste. The bill
also allows a solid waste facility operator to make
arrangements for proper disposal of the discovered medical
waste on their own, if they choose to do so.
9) The MWMA allows DPH to charge application and permit fees for
transfer stations and new treatment technologies based on
statutory limits or as provided in adopted regulations.
(��118045 and 118245)
a) The bill removes the provision related to regulations for
fees.
10)The MWMA requires offsite medical waste treatment facilities to
file an application to DPH detailing the site's operations.
(�118155)
a) The bill changes the requirements, including removing a
reporting requirement for the average monthly quantity of
waste treated at the facility and requiring a closure plan
that details the method used to render the property to
sanitary conditions.
AB 333
Page 5
11)The MWMA requires containerized or stored medical waste to meet
various requirements. (�118275)
a) The bill defines 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. The
bill also contains additional labeling and containerization
requirements.
12)The MWMA requires biohazardous waste to meet various
requirements, including procedures for how the bags are filled
and tied. Biohazardous waste may only be stored at a location
above freezing for seven days. (�118280)
a) The bill changes the usage of biohazardous bags in certain
health care settings and changes the biohazardous waste
storage requirements at transfer stations.
13)The MWMA provides requirements for the handling of trauma scene
waste. (�118321 et seq.)
a) The bill changes the hauling requirements to provide
trauma scene waste haulers a Materials of Trade exception.
(�118321.5)
14)The bill makes technical corrections to remove implementation
language from when the Act was enacted. The bill makes other
various technical corrections to the Act.
COMMENTS :
1) Purpose of Bill . According to the author, "It is widely
recognized that the Medical Waste Management Act is in need of
being updated. [?] The current Medical Waste Management Act
was implemented in 1991 and federal agencies (Department of
Transportation and US Postal Service) now regulate
transportation of medical waste and preempt the state
requirements. This creates conflict for California healthcare
facilities and places them at risk of noncompliance with federal
AB 333
Page 6
statutes. Administrative solutions cannot fix the problem as
there is a conflict in the statutes governing medical waste
treatment and transportation. [?]
"AB 333 has 3 major goals: to conform CA law with changes in
federal law, to alleviate internal inconsistencies and
ambiguities and to simplify and clarify the act. Last year, the
bill sponsors and staff met with CDPH and CalRecycle staff to
preview a comprehensive reform in the MWMA. Over the past 2
years, a broad group of stakeholders have met to work on
amendments to the MWMA. Stakeholders included representatives
of hospitals, clinics, dentists, other waste management
businesses, local public health officials, veterinarian
medicine, retailers, and others impacted by any changes."
2) Genesis of the MWMA . In the fall of 1989, there were 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. In response to these
incidents, both the Legislature and the executive branch
considered new approaches to handling medical waste.
At the time, California statute only defined "infectious waste" as
wastes that contain infectious organisms that cause human
disease. This waste was treated as hazardous waste; however,
this definition severely limited the types of wastes that could
be regulated.
In 1989 and 1990, bills were introduced by Assembly Member Hayden
(AB 109) and Assembly Member Mojonnier (AB 1641). The goal of
the bills was to respond to general concerns over the lax
management of medical and infectious wastes and address specific
issues identified in California and at the national level.
Ultimately, the two bills were combined to form the Medical Waste
Management Act (MWMA) and, according to the original Legislative
intent, "comprise a single, integrated, and complementary
approach to the storage, treatment, transportation, and disposal
of medical waste" (Chapters 1613 and 1614, Statutes of 1990).
The MWMA was placed under the Department of Health Services.
During this same period, Congress enacted the Medical Waste
Tracking Act (MWTA, 1988) to create a two year medical waste
AB 333
Page 7
demonstration project. This project was designed to define
medical waste and those wastes to be regulated, establish
cradle-to-grave tracking procedures, and require regulations for
standard practices regarding medical waste. However, the
regulations developed under MWTA expired in 1999, leaving this
matter under state jurisdiction.
3) Timeline of additions to the MWMA since 1990 . The current bill
is one of many attempts to further change or update the MWMA
since its introduction.
In 1995, SB 372 (Wright, Chapter 877) made various changes to the
MWMA, including revisions to the definition of large quantity
generator, medical waste exclusions, and storage. The bill also
incorporated additional classes into the definition of medical
waste and authorized the use of high temperatures to treat
medical waste prior to disposal.
Also in 1995, the MWMA was moved to the Department of Public Health
(DPH) during Governor Wilson's reorganization of the Department
of Health Services to DPH and the California Environmental
Protection Agency (SB 1360, Committee on Health and Human
Services, Chapter 415 of 1995).
SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the
management and handling of waste pharmaceuticals under DPH and
the MWMA and reestablished fee authorities for DPH for small
quantity medical waste generators.
In 1997, SB 1034 (Maddy, Chapter 732) added trauma scene waste
management to the MWMA. This addition required the registration
of commercial firms who clean up trauma scenes in order to
ensure appropriate training and disposal of waste.
Two years later, SB 407 (Alpert, Chapter 139, Statutes of 1999)
authorized the use of chemical disinfection as a treatment
method for certain types of laboratory-generated medical waste
if specified requirements were met.
AB 2335 (Saldana, Chapter 166, Statutes of 2006) made various
clarifying changes to the MWMA with the aim of reducing medical
waste management costs and clarifying the complex regulatory
framework.
AB 333
Page 8
AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defined
pharmaceutical waste, exempted the waste generator from certain
hauling requirements, and allowed the waste to be transported by
a common carrier in order to reduce costs for handling expired
pharmaceutical wastes.
4) Recommended amendments .
a) Definitions . In the bill, several definitions were
combined or expanded. In the process, several definitions
are no longer clear or reflect their original intention.
An amendment is needed to clarify and unify the definition of
"treatment."
An amendment is needed to the definition of "medical waste" to
reflect that the conditions detailed in that section must be
met for the waste to be excluded from hazardous waste
requirements.
An amendment is needed to strike the phrase "contaminated with
biohazardous waste" from the definition of "sharps waste" in
order to clarify that waste sharps, regardless of whether or
not they were used, should be handled as described in the
bill.
An amendment is needed to define land to be "under the control"
of a medical waste treatment facility to be through
ownership, lease, or agreement.
b) Health care professionals . The bill replaces the current
definition of "health care professional," which is currently
based on licensure or certification, to more broadly include
any person who generates medical waste in a health care
setting or in the course of providing a health care service.
In the context of the MWMA, health care professionals have a
variety of responsibilities, including logging the generation
of wastes, transporting medical waste for home health care,
and authorizing the transport of medical waste.
Is this definition overly broad? What are the unintended
consequences of removing the licensure or certification
AB 333
Page 9
requirement for health care professionals?
An amendment is needed to remove the new definitions of health
care professionals, settings, and services in favor of the
current licensure-based definition of "health care
professional" in the MWMA.
c) Temporary events . The bill allows LQGs to participate in
temporary events, such as health fairs, vaccination clinics,
and veteran stand downs, without requiring additional
permitting or registration. However, it is important to
ensure that the local enforcement agency is aware of such
participation before it occurs. In addition, the bill does
not grant similar provisions for SQGs participating in a
temporary event.
Amendments are needed to require a LQG to inform the LEA of
its intended participation in a temporary event at least 72
hours before the event and to allow an SQG to use their
existing permits or registrations to participate in temporary
events in a similar fashion.
d) Transport of medical waste . The bill provides that the
only individuals authorized to haul medical waste are
registered waste haulers, USPS, a common carrier for
pharmaceutical waste, or "a small quantity generator or a
large quantity generator that has an exemption granted
pursuant to" the Materials of Trade exception. This language
is overly broad, and could suggest that all waste from an SQG
or LQG that has this exception could haul their own medical
waste.
An amendment is needed to specify that, for the purposes of
hauling medical waste, an SQG or LQG may only transport
medical waste pursuant to the granted Materials of Trade
exception.
The bill also provides a Materials of Trade exception for
organizations that collect and haul trauma scene waste.
However, these organizations are not granted authority to
haul medical waste under the powers and duties requirements.
AB 333
Page 10
An amendment is needed to specify that trauma scene waste
handlers granted a Materials of Trade exception may haul
medical waste.
e) Medical waste management and treatment plans . The bill
provides a general provision that SQGs and LQGs must provide
their medical waste management plans on forms from the LEAs,
if the forms are provided. However, the bill is inconsistent
in implementing this requirement.
An amendment is needed to require the plans be completed on
forms from the LEAs, if the forms are provided.
In the bill, there are inconsistencies between the requirements
placed on SQGs and LQGs. Although certain differences are
expected between these facility types, the language used in
the bill is confusing and should be clarified in order to
ensure proper compliance.
Amendments are needed in the SQG registration requirements to
specify which types of information are required, and which
are necessary only if they are applicable to the facility.
The bill requires treatment facilities and SQGs and LQGs that
treat medical waste onsite to provide a closure plan with
their registration and, in the case of treatment facilities,
the methods that can be used for decontamination are
specified. First, all closure plans related to the treatment
of medical waste should be consistent in their requirements.
Second, the decontamination procedures listed for treatment
facilities may not be sufficient to "render the property to
an acceptable sanitary condition."
Amendments are needed to specify that the decontamination
procedures listed for treatment facilities are a minimum
requirement, and to require SQGs and LQGs to follow the same
procedures as treatment facilities.
The bill removes a requirement for treatment facilities to
provide DPH with an estimate of the monthly quantity of waste
treated at that facility. Although the monthly quantity of
waste treated over time may change, this metric provides a
useful standard for DPH in evaluating the treatment facility.
AB 333
Page 11
An amendment is needed to require treatment facilities to
provide the estimated initial average monthly quantity of
waste treated at the facility.
f) Training requirements . The bill adds requirements for
SQGs and LQGs that treat medical waste onsite to provide
annual training for personnel who operate treatment
equipment. Given that worker training is under the purview
of the Occupational Safety and Health Administration (OSHA),
it would be appropriate to reference the requirements of that
agency in this section.
Amendments are needed to specify that training related to
medical waste treatment at SQGs and LQGs should be
commensurate with applicable regulations under OSHA.
g) Unified state policy . When the Act was originally
created, San Diego was the only county with a preexisting
medical waste act. As a result, San Diego County's medical
waste program was grandfathered in to the state program.
Some of the requirements of San Diego's medical waste program
go farther than the MWMA; for example, all medical waste
generators, including biotech companies and pharmacies, are
regulated under the County's program, and facilities must
label waste containers with the name of the facility.
According to DPH, counties who choose to implement and enforce
their own medical waste management programs use the MWMA as a
framework. Their implemented programs must be, at a minimum,
equivalent to the MWMA. Counties may adopt more stringent
standards through the use of local ordinances if they see fit
to do so.
If the goal of this bill is to ensure consistency for the
handling of medical waste in California, does it make sense
for San Diego County to retain this preemption, especially if
they are already permitted to enact more stringent
requirements? Does this perpetuate the confusion caused by
inconsistent standards that the bill aims to address?
An amendment is needed to remove this preemption from the bill.
AB 333
Page 12
h) Technical corrections . There are several missing or
erroneous cross references throughout the bill.
Amendments are needed to insert or correct cross references
throughout the bill, in addition to other technical
corrections to ensure consistency and accuracy.
5) Policy consideration: Fee collection . The bill allows DPH to
enable medical waste transporters to collect SQG fees for the
department and retain up to 7.5% of the fee for administrative
costs.
The collected fee is currently set at a fixed value of $25.
Although this fee may have been appropriate in 1991, the parties
that collect this fee are currently losing money. Would it be
more appropriate to require this fee to be "commensurate with
the cost to administer the program"?
Under the current system, generators that switch haulers during the
course of a year would have to pay their annual fee again to the
second hauler. This problem only arises because DPH does not
directly collect the fees.
This raises several overarching concerns with the DPH SQG fee
collection program:
Is it appropriate for private haulers to collect fees for a state
program? What is gained by having private haulers collect the
fees? Does DPH do this for any other program? Do any other
state agencies delegate their fee authority?
6) Additional concerns by the California Association of
Environmental Health Administrators (CAEHA) . The Senate
Environmental Quality Committee received a letter from CAEHA,
dated May 26, 2014, that outlined several requested amendments.
CAEHA represents local environmental health departments, LEAs,
and certified unified public agencies (CUPAs). CAEHA has been
in discussions with the stakeholders on the bill for the last 15
months; however, CAEHA has several additional concerns that they
feel are not currently addressed in the legislation, including:
? References to federal requirements, including the DOT,
shipping documents, and Materials of Trade exception, should
include the relevant sections, rather than providing broad
cross-references.
AB 333
Page 13
? Record retention for medical waste and hazardous waste
should be consistent (i.e., both should be three years).
? Home-generated wastes should be addressed.
Of particular concern for CAEHA is the order for compliance and
administrative penalty. "Existing law established
administrative enforcement provisions to support the
implementation and enforcement of the MWMA. Due to resource
constraints the Department has not adopted regulations to
prescribe the process for LEAs to exercise this administrative
enforcement authority since the MWMA went into effect in 1990.
This omission prevents consistent statewide administrative
enforcement of this Act and, in some cases, results in no
enforcement action. CAEHA proposes that the administrative
enforcement procedures established for the enforcement of [CUPAs
?] be echoed in AB 333 in order to clarify to establish the
necessary due process and enhance regulatory consistency."
Is it appropriate for this legislation, which is intended to
update and clarify the MWMA, to address an issue that may be
regulatory in nature?
1) Related bills .
AB 467 (Stone), Chapter 10 of 2014 created a licensure category for
a surplus medication collection and distribution intermediary.
AB 1893 (Stone and Eggman) of 2014 would have made various changes
to the handling of home-generated sharps. This bill failed on
the Assembly Floor.
SB 1014 (Jackson) of 2014 deals with changes to the disposal of
home-generated pharmaceutical waste and defines home-generated
pharmaceutical waste as not medical waste. This bill is
currently in the Assembly.
SOURCE : Stericycle Inc
SUPPORT : None on file
OPPOSITION : None on file
AB 333
Page 14