BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 333|
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THIRD READING
Bill No: AB 333
Author: Wieckowski (D)
Amended: 8/22/14 in Senate
Vote: 21
SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 6/18/14
AYES: Hill, Gaines, Fuller, Hancock, Jackson, Leno, Pavley
SENATE APPROPRIATIONS COMMITTEE : 5-0, 8/14/14
AYES: De Le�n, Hill, Lara, Padilla, Steinberg
NO VOTE RECORDED: Walters, Gaines
ASSEMBLY FLOOR : 67-6, 5/23/13 - See last page for vote
SUBJECT : Medical waste
SOURCE : Stericycle Inc.
DIGEST : This bill makes numerous changes to the Medical Waste
Management Act (MWMA) including, among other things, codifying
existing federal preemptions and requirements, modifying
definitions, creating procedures for the generation of medical
waste from a temporary event, modifying contracts with medical
waste transporters for the collection of fees, and preempting
local programs regarding infectious waste. Requires the
Department of Public Health (DPH) to submit a report to the
Legislature by no later than January 1, 2016, describing the
interaction of federal and state law for the transport of
regulated medical waste and requires the DPH to convene a
stakeholder group for that purpose.
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Senate Floor Amendments of 8/22/14 provide a pathway for the DPH
to reconcile differences between state and federal law, require
tracking and shipping documents, and make technical corrections.
ANALYSIS :
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.
2.Authorizes the United States Postal Service (USPS) to regulate
medical waste and sharps waste containers that are transported
through the mail.
Existing state law requires, under the MWMA, the 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:
1.Codifies the federal preemptions and requirements under DOT
and USPS for the transportation and tracking of medical waste.
2.Expands the definition of "treatment" to specify the purpose
of treatment for each subset of medical waste and authorizes
the color coding of biohazard bags as follows: yellow bags are
used to further segregate trace chemotherapy waste and white
bags are used to further segregate pathology waste.
3.Increases the fees for medical waste to 7.5% and removes the
provision allowing providers of mail-back systems to collect
fees.
4.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
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MWMA prior to leaving the state.
5.Requires a medical waste generator to maintain for a minimum
of three years individual treatment operating records, and if
applicable, shipping and tracking documents for all untreated
medical waste shipped offsite for treatment, and shall report
or submit to the enforcement agency, upon request, all of the
following:
A. Treatment operating records. Operating records shall be
maintained in written or electronic form.
B. An emergency action plan complying with regulations
adopted by the DOT.
C. Shipping and tracking documents or electronically
archived shipping and tracking documents maintained by the
facility and medical waste hauler of all untreated medical
waste shipped offsite for treatment.
1.Makes various changes to the provisions relating to medical
waste haulers, including removing provisions that conflict
with the DOT regulation of those entities, authorizing a
registered trauma scene waste practitioner, as specified, to
haul medical waste, and making changes to the information
medical waste haulers are required to provide to the DOT.
2.Makes various changes to the provisions relating to medical
waste treatment facilities, including specifying the
decontamination methods for a closure plan, lowering the time
period for which records are maintained from three to two
years, and authorizing the use of electronic information for
operating records and shipping and tracking documents.
3.Revises the registration procedures and the record
requirements for large quantity and small quantity generators
and requires large and small quantity generators that operate
treatment equipment to receive annual training to operate the
equipment.
4.Authorizes a registered large quantity or small quantity
medical waste generator to generate medical waste at a
temporary event, including vaccination clinics, and requires
the large quantity or small quantity generator to notify the
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enforcement agency of its participation at such an event at
least 72 hours before the event, unless the sponsor of the
temporary event previously notified the local enforcement
agency of the event.
5.Exempts from regulation as a hazardous waste hauler a small
quantity generator or large quantity generator that meets
specified requirements, including retaining specified
documentation and complying with certain federal requirements
relating to materials of trade exception.
6.Authorizes a small quantity medical waste generator or parent
organization that employs health care professionals who
generate medical waste to transport medical waste generated in
limited quantities up to 35.2 pounds to the central location
of accumulation, provided that all of the following are met:
A. The principal business of the generator is not to
transport or treat regulated medical waste.
B. The generator shall adhere to the conditions and
requirements set forth in the materials of trade exception,
as specified.
C. A person transporting medical waste pursuant to this
section shall provide a form or log to the receiving
facility, and the receiving facility shall maintain the
form or log for a period of two years, containing specified
information.
1.Exempts persons, who unknowingly transports medical waste to a
solid waste facility from the MWMA, and requires the solid
waste transporter to contact the originating generator of the
medical waste to respond to the facility to provide ultimate
proper disposal of the medical waste.
2.Requires the carcasses of animals that have died of infectious
diseases or that have been euthanized because of suspected
exposure to infectious disease to be treated with a treatment
technology approved by the DOT if, in the opinion of the
attending veterinarian or local health officer, the carcass
presents a danger of infection to humans.
3.Requires the DOT to charge an application fee for a permit for
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a transfer station equal to $100 for each hour which the DOT
spends on processing the application, but not more than
$10,000, or as provided in the regulations adopted by the DOT,
not to exceed the reasonable regulatory costs of the DOT. In
addition, the annual permit fee for a transfer station is
$2,000, or as provided in the regulations adopted by the DOT,
not to exceed the reasonable regulatory costs of the DOT.
4.Requires the DPH to submit a report to the Legislature by no
later than
January 1, 2016, describing the interaction of federal and state
law for the transport of regulated medical waste and requires
the DPH to convene a stakeholder group for that purpose.
5.Authorizes the DPH to update standards related to the
transportation of medical waste during transport through a
guidance document, as specified.
6.Authorize the DPH to temporarily waive the transportation
requirements of this bill while a federal preemption
determination is pending, as specified.
7.Provides that during this period of temporary waiver, or if
federal preemption is found, the federal requirements will be
deemed to be the law of this state and enforceable by the DPH.
8.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 bio-hazardous waste.
Background
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,
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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 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
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.
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, Statutes of 1995).
SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the
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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.
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 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.
Related Legislation
AB 467 (Stone, Chapter 10, Statutes of 2014) created a licensure
category for a surplus medication collection and distribution
intermediary.
AB 1893 (Stone and Eggman, 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
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Initial costs of $156,000 annually from the Medical Waste
Management Fund (special) for FY 2015-16 and FY 2016-17 to
assist with compliance with the changes to the MWMA.
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.
SUPPORT : (Verified 8/22/14)
Stericycle Inc. (source)
California Hospital Association
Kaiser Permanente
OPPOSITION : (Verified 8/22/14)
Department of Finance
ARGUMENTS IN SUPPORT : Kaiser Permanente writes, "The Medical
Waste Management Act was created 23 years ago and is in need of
modernizing to be more reflective of the changes in federal law
that govern transport of these waste products. AB 333 deletes
some out-of-date provisions to the MWMA; provides definitions
for new processes and terminology; re-drafts the law to
reorganize sections of the act to make it more user-friendly and
easier to follow, and it better coordinates state transportation
requirements with the federal transportation requirements,
providing for more consistency in the requirements of each
jurisdiction.
"There has been extensive effort to develop a consensus bill
within the stakeholder community, and I laud you and your staff
for your leadership in this complicated policy area."
ARGUMENTS IN OPPOSITION : The Department of Finance is opposed
to this bill because it eliminates Public Health's authority to
adjust application and permit fees for medical waste transfer
stations and onsite treatment facilities through the regulations
process. If current fees are not adequate to cover future
program costs, the Medical Waste Management Program could be
negatively impacted and Public Health would be forced to
increase fees by amending statute, which may not allow Public
Health to adjust fees in a timely manner. Furthermore, this
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bill imposes additional costs and workload on Public Health.
ASSEMBLY FLOOR : 67-6, 5/23/13
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Chesbro, Cooley, Dahle,
Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth Gaines,
Garcia, Gatto, Gomez, Gordon, Gorell, Gray, Hall, Harkey,
Roger Hern�ndez, Jones-Sawyer, Levine, Linder, Logue,
Lowenthal, Maienschein, Medina, Melendez, Mitchell, Morrell,
Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson,
Perea, V. Manuel P�rez, Quirk, Quirk-Silva, Rendon, Salas,
Skinner, Stone, Ting, Wagner, Weber, Wieckowski, Williams,
Yamada, John A. P�rez
NOES: Bigelow, Ch�vez, Conway, Donnelly, Hagman, Wilk
NO VOTE RECORDED: Grove, Holden, Jones, Mansoor, Waldron,
Vacancy, Vacancy
RM:e 8/25/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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