BILL ANALYSIS �
AB 1442
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2011-2012 Regular Session
BILL NO: AB 1442
AUTHOR: Wieckowski
AMENDED: June 14, 2012
FISCAL: Yes HEARING DATE: July 2, 2012
URGENCY: No CONSULTANT: Rebecca Newhouse
SUBJECT : PHARMACEUTICAL WASTE: COMMON CARRIER
SUMMARY :
Existing law ,
1)Under the federal Resource Conservation and Recovery Act (RCRA),
regulates the management of solid and hazardous wastes.
2)Under the Radiation Control Law (Health and Safety Code �114960
et seq.) regulates and controls sources of ionizing radiation.
3)Under the Medical Waste Management Act (MWMA) (�117600 et seq.):
a) Defines "pharmaceuticals" as a prescription or
over-the-counter human or veterinary drug including, but not
limited to, a drug as defined in the Sherman Food, Drug and
Cosmetic Law or the Federal Food, Drug, and Cosmetic Act.
"Pharmaceutical" does not include any pharmaceutical that is
regulated pursuant to either RCRA or the Radiation Control
Law.
b) Specifies that waste comprised only of pharmaceuticals is
hazardous, and is considered "medical waste," although it is
not subject to hazardous waste laws, as specified.
c) Requires medical waste generators to maintain on file, or
file with the enforcement agency, specified documents
relating to the maintenance, treatment and transport of
medical waste.
d) Requires all medical waste be transported to an offsite
medical waste treatment facility to be transported by a
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registered hazardous waste transporter.
e) Exempts specified medical waste generators from the
requirement in d) if they are granted a limited-quantity
waste hauling exemption from the enforcement agency and meet
specified requirements including:
i) Maintaining on file, or filing with the enforcement
agency, specified documents relating to the maintenance,
treatment and transport of medical waste.
ii) The requirement that the generator or health care
professional who generated the medical waste transports the
medical waste himself or herself, or directs a member of
his or her staff to transport the medical waste to a
permitted medical waste treatment facility, a transfer
station, a parent organization, or another health care
facility for the purpose of consolidation before treatment
and disposal.
iii) Maintaining a tracking document, as specified, unless
the health care professional who generates and 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.
f) Requires that medical waste treatment facilities maintain
specified records for three years, including copies of the
tracking documents for all medical waste it receives for
treatment from offsite generators or hazardous waste haulers.
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
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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.
2)Defines "pharmaceutical waste" as any pharmaceutical that for
any reason may no longer be sold or dispensed for use as a drug.
Excludes from this definition those pharmaceuticals that still
have potential value to the generator because they are being
returned to a reverse distributor for possible manufacturer
credit.
3)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.
4)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
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discrepancies between the items received and the tracking
document, and requiring the generator to notify the
enforcement agency of any 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.
5)Requires that medical waste treatment facilities maintain copies
of tracking documents from common carriers.
COMMENTS :
1) Purpose of Bill . According to the author, "Under existing law,
pharmaceutical drugs can be sent to healthcare facilities
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."
2) 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 RCRA. Some pharmaceutical waste that is not identified
under the RCRA may be deemed hazardous under California
standards, and subsequently classified as medical waste and
therefore subject to the MWMA. The Department of Public Health
(DPH) oversees the MWMA and regulates medical waste.
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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.
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.
3) Environmental concerns . A 2002 study by the US Geological
Survey (USGS) 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 US 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
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compliance with proper disposal procedures for pharmaceutical
waste by health facilities, and potentially reduce
pharmaceutical contamination in California wastewater.
4) Amendment needed . To avoid conflicts with the existing Medical
Waste Management Act, the amendments in �118040 of AB 1442
should be stricken.
5) Arguments in support . Supporters say that AB 1442 will clarify
and reduce the burden of compliance with the Medical Waste
Management Act for health facilities and substantially decrease
the amount of pharmaceuticals entering our water system.
6) Related legislation . SB 966 (Simitian) Chapter 542, Statutes
of 2007, required Integrated Waste Management Board model
programs for the collection and proper disposal of
pharmaceutical drug waste by December 1, 2008.
SOURCE : Assemblymember Wieckowski
SUPPORT : American Federation of State, County and Municipal
Employees
Bay Area Clean Water Agencies
California Product Stewardship Council
Californians Against Waste
California Veterinary Medical Association
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
OPPOSITION : California Board of Pharmacy (oppose unless
amended)
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Note: The latest set of amendments addressed many
of the Board of Pharmacy's concerns. The Board is
expected to formally remove its opposition at its
July 17th Board Meeting and go neutral, as
recommended by the Board's Legislation and
Regulation Committee.