BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 1442|
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THIRD READING
Bill No: AB 1442
Author: Wieckowski (D), et al.
Amended: 8/21/12 in Senate
Vote: 21
SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 7/2/12
AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe,
Lowenthal, Pavley
SENATE APPROPRIATIONS COMMITTEE : 7-0, 8/16/12
AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price,
Steinberg
ASSEMBLY FLOOR : 78-0, 5/30/12 - See last page for vote
SUBJECT : Pharmaceutical waste
SOURCE : Author
DIGEST : This bill defines pharmaceutical waste for
purposes of the Medical Waste Management Act, and exempts a
pharmaceutical waste generator or parent organization that
employs health care professionals who generate
pharmaceutical waste from specified medical waste hauling
requirements if the generator, health care professional, or
parent organization retains specified documentation and
meets specified requirements and if the facility receiving
the medical waste retains specified documentation and meets
specified requirements. This bill also authorizes
pharmaceutical waste to be transported by the generator or
CONTINUED
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health care professional who generated the pharmaceutical
waste, a staff member of the generator or health care
professional, or common carrier, as defined, pursuant to
these provisions.
ANALYSIS : The existing Medical Waste Management Act,
administered by the State Department of Public Health,
regulates the management and handling of medical waste, as
defined. Existing law requires that all medical waste be
hauled by either a registered hazardous waste hauler or by
a person with an approved limited-quantity exemption
granted pursuant to specified provisions of law. Violation
of these provisions of law is a crime.
This bill:
1.Defines "common carrier" as either of the following:
A. A person or company that has a United States
Department of Transportation number issued by the
Federal Motor Carrier Safety Administration and is
registered with the Federal Motor Carrier Safety
Administration as a for-hire property carrier.
B. A person or company that has a motor carrier of
property permit issued by the Department of Motor
Vehicles pursuant to the Motor Carriers of Property
Permit Act and, if applicable, a carrier
identification number issued by the Department of the
California Highway Patrol.
1.Defines "pharmaceutical waste" as any pharmaceutical that
for any reason may no longer be sold or dispensed for use
as a drug. Pharmaceutical does not include any
pharmaceutical that meets either of the following
criteria:
A. The pharmaceutical is being sent out of the State
of California to a reverse distributor, as defined,
that is licensed as a wholesaler of dangerous drugs by
the California State Board of Pharmacy.
B. The pharmaceutical is being sent by a reverse
distributor, as defined, offsite for treatment and
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disposal in accordance with applicable laws, or to a
reverse distributor that is licensed as a wholesaler
of dangerous drugs by the California State Board of
Pharmacy as is permitted transfer stations if the
reverse distributor is located within the State of
California.
1.Specifies that medical generators keep the name of the
common carrier used by the generator to transport
pharmaceutical waste offsite for treatment and disposal,
on file, or file that information with the enforcement
agency, along with other required information relating to
the maintenance, treatment and transport of medical
waste.
2.Exempts a pharmaceutical waste generator or parent
organization that employs health care professionals who
generate pharmaceutical waste from the hazardous waste
hauling requirement if the generator, health care
professional, or parent organization meets certain
specified requirements, including:
A. Maintaining on file, or filing with the enforcement
agency, specified documents relating to the
maintenance, treatment and transport of medical waste.
B. The requirement that the generator or health care
professional who generated the pharmaceutical waste
transports the pharmaceutical waste himself or
herself, or directs a member of his or her staff to
transport the pharmaceutical waste to a parent
organization or another health care facility for the
purpose of consolidation before treatment and
disposal, or contracts with a common carrier to
transport the pharmaceutical waste to a permitted
medical waste treatment facility or transfer station.
C. Maintaining and providing a tracking document, as
specified, to the intended destination facility,
requiring the destination facility to notify the
generator of any discrepancies between the items
received and the tracking document, and requiring the
generator to notify the enforcement agency of any
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discrepancies, unless the health care professional who
generates pharmaceutical waste returns the
pharmaceutical waste to the parent organization, and
under that case, is authorized to substitute a
single-page form or multiple entry log for the
tracking document if the form or log contains
specified information.
1.Requires that medical waste treatment facilities maintain
copies of tracking documents from common carriers.
Background
Some pharmaceutical wastes are classified as hazardous
wastes. Others are medical waste, and still others are
nonhazardous wastes. Which category a discarded
pharmaceutical falls into depends on its chemical,
physical, and toxicological properties and who generates
the waste. The California Code of Regulations dictates
that the generator of the waste is ultimately responsible
for proper classification of waste streams and subsequently
managing and disposing of the waste according to the
appropriate rule governing each waste classification.
The Department of Toxic Substances Control regulates
pharmaceutical wastes that are considered hazardous under
the federal Resource Conservation and Recovery Act. Some
pharmaceutical waste that is not identified under the Act
may be deemed hazardous under California standards, and
subsequently classified as medical waste and therefore
subject to the Medical Waste Management Act (MWMA). The
Department of Public Health (DPH) oversees the MWMA and
regulates medical waste.
The MWMA specifies that medical waste, including
pharmaceutical waste comprised of nonsalable and outdated
prescription and over-the-counter drugs must be transported
by a licensed hazardous waste hauler. If they meet certain
requirements, medical waste generators can apply for a
limited-quantity waste hauling exemption, and the generator
of the medical waste may transfer the waste themselves to a
medical waste treatment facility. These exemptions last
one year, and do not allow the medical waste transporter to
contract with a common carrier.
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Current law is not clear regarding what constitutes
"pharmaceutical waste," but according to DPH's
Self-Assessment Manual for Proper Management of Medical
Waste, pharmaceuticals that have "intrinsic value," or are
creditable, are not considered waste and can be returned by
a common carrier to a reverse distributer, which is
licensed by the Board of Pharmacy to handle outdated or
nonsalable prescription drugs and regulated by DPH to
handle pharmaceuticals registered as medical waste. AB
1442 would define "pharmaceutical waste," as a subset of
medical waste currently included in the DPH MWMA manual and
allow pharmaceutical wastes to be transported by a common
carrier as is authorized in most other states.
Environmental concerns. A 2002 study by the US Geological
Survey revealed widespread contamination in US waterways of
prescription drugs, natural and synthetic hormones,
detergent metabolites, plasticizers, insecticides, and fire
retardants at low concentrations downstream from areas of
intense urbanization and animal production. The results
found that one or more of these chemicals were found in 80
percent of the streams sampled. Prescription drugs are of
particular concern because of the low concentration
necessary for activity in the body. According to the U.S.
EPA, further research suggests that certain drugs may cause
ecological harm and that more research is needed to
determine the extent of harm and any role they may have in
potential human health effects.
California health facilities that generate large amounts of
pharmaceutical waste must currently follow strict and
costly handling and transporting protocols for medical
waste. Allowing these facilities to transport
pharmaceutical waste via common carrier may lessen the
financial burden, and improve compliance with proper
disposal procedures for pharmaceutical waste by health
facilities, and potentially reduce pharmaceutical
contamination in California wastewater.
Comments
According to the author, "Under existing law,
pharmaceutical drugs can be sent to healthcare facilities
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through common carriers, or standard shipping means.
Unused drugs can sometimes be returned to the manufacturer
for credit, via a common carrier. Expired and
non-dispensable drugs must be shipped as "Medical Waste",
requiring expensive hazardous waste shipping, instead of
common carrier. This is unnecessarily expensive for
pharmacies, hospitals, and other health care facilities,
who are simply returning the exact same drug that was
shipped to them by common carrier."
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee, $280,000
from the Medical Waste Management Fund in 2013-14 and
2014-15 for two full time and one limited term Department
of Public Health staff to coordinate with stakeholders
statewide, oversee rulemaking process and develop
regulations and $160,000 annually thereafter to review
exemption requests and ensure compliance with documentation
requirements.
SUPPORT : (Verified 8/20/12)
American Federation of State, County and Municipal
Employees
Bay Area Clean Water Agencies
California Product Stewardship Council
Californians Against Waste
Central Contra Costa Solid Waste Authority
City of Palo Alto
City of San Jose
City of Sunnyvale
Clean Water Action
East Bay Municipal Utility District
EXP Pharmaceutical Services Corp.
Fremont Chamber of Commerce
Los Angeles County Solid Waste Management Committee IWM
Task Force
San Francisco Water Power Sewer
Santa Clara Valley Water District
Sierra Club California
Solid Waste Association of North America
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ASSEMBLY FLOOR : 78-0, 5/30/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fong, Fuentes, Furutani, Beth
Gaines, Galgiani, Garrick, Gatto, Gordon, Gorell, Grove,
Hagman, Halderman, Hall, Harkey, Hayashi, Roger
Hern�ndez, Hill, Huber, Hueso, Huffman, Jeffries, Jones,
Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor,
Mendoza, Miller, Mitchell, Monning, Morrell, Nestande,
Nielsen, Norby, Olsen, Pan, Perea, V. Manuel P�rez,
Portantino, Silva, Skinner, Smyth, Solorio, Swanson,
Torres, Wagner, Wieckowski, Williams, Yamada, John A.
P�rez
NO VOTE RECORDED: Fletcher, Valadao
DLW:n 8/21/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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