BILL ANALYSIS �
AB 1442
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Date of Hearing: March 20, 2012
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Bob Wieckowski, Chair
AB 1442 (Wieckowski) - As Amended: February 6, 2012
SUBJECT : Pharmaceutical waste.
SUMMARY : Authorizes the transportation of pharmaceutical waste,
as defined, by a common carrier. Specifically, 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.
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)Authorizes a medical waste generator or parent organization
that employs health care professionals who generate
pharmaceutical waste to apply to the enforcement agency for a
pharmaceutical waste hauling exemption if the generator,
health care professional, or parent organization meets all of
the following requirements:
a) The generator or parent organization has on file one of
the following:
i) If the generator or parent organization is a small
quantity generator required to register with the
enforcement agency, the required medical waste management
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plan, as defined in statute.
ii) If the generator or parent organization is a small
quantity generator not required to register, the
information document, as defined in statute.
iii) If the generator or parent organization is a large
quantity generator, a medical waste management plan, as
defined in statute.
b) 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) The generator maintains a tracking document, as defined
in statute.
d) The health care professional who generates and returns
the pharmaceutical waste to the parent organization is
authorized to substitute a single-page form or multiple
entry log for the tracking document if the form or log
contains specified information.
4)Clarifies that this bill does not prohibit the use of a single
document to verify the return of more than one container to a
parent organization or another health care facility for the
purpose of consolidation before treatment and disposal over a
period of time, if the form or log is maintained in the files
of the parent organization or another health care facility
that receives the waste once the form or log is completed.
5)Makes other conforming changes.
EXISTING LAW :
1)Requires, under the federal Controlled Substances Act, strict
protocols for the collection of controlled substances to
prevent their illegal diversion and abuse.
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2)Regulates, under the federal Resource Conservation and
Recovery Act (RCRA) of 1976, the management of solid and
hazardous wastes.
3)Authorizes, under the California Hazardous Substances Act, the
Department of Toxic Substances Control (DTSC) to regulate
hazardous materials and wastes to ensure that the state is
delegated authority in accordance with RCRA.
4)Establishes the Sherman Food, Drug, and Cosmetic Law,
administered by the Department of Public Health (DPH), to
regulate drugs and medical devices.
5)Provides for, under the Business and Professions Code, the
licensure and regulation of pharmacies, pharmacists, and
wholesalers of dangerous drugs or devices by the Board of
Pharmacy (BOP) within the Department of Consumer Affairs.
6)Defines "dangerous drug" or "dangerous device" as any
prescription drug or device unsafe for self-use in humans or
animals, as specified (Business and Professions Code (BPC)
�4022).
7)Defines "reverse distributor" as every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and
other entities by receiving, inventorying, and managing the
disposition of outdated or nonsalable dangerous drugs (BPC
�4040.5).
8)Establishes the Medical Waste Management Act (MWMA) in Health
and Safety Code (HSC) Sections 117600 - 118360. Under the
MWMA,:
a) Requires the DPH to adopt regulations that will
establish and ensure statewide standards for uniformity in
the implementation and administration of the MWMA and that
will promote waste minimization and source reduction (HSC
�117610).
b) Includes in the definition of "medical waste"
biohazardous waste (HSC �117690). Includes in the
definition of "biohazardous waste" waste that is hazardous
only because it is comprised of pharmaceuticals (HSC
�117635).
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c) Defines "pharmaceutical" as a prescription or
over-the-counter human or veterinary drug including, but
not limited to, a drug as defined the Sherman Food, Drug
and Cosmetic Laws 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 (HSC �117747).
d) Establishes a system to register and oversee small and
large quantity medical waste generators. Requires
generators to maintain on file or file with the enforcement
agency specified documents relating to the maintenance,
treatment and transport of medical waste (HSC �117915 et
seq.).
e) Prohibits a person from hauling medical waste unless the
person is either a registered hazardous waste hauler or has
an approved limited-quantity exemption (HSC �117900).
f) Establishes a system to register and oversee medical
waste haulers (HSC �118000 et seq.).
i) Requires all medical waste transported to an offsite
medical waste treatment facility to be transported by a
registered hazardous waste transporter (HSC �118000).
ii) Authorizes a medical waste generator or parent
organization that employs health care professionals who
generate medical waste to apply to the enforcement agency
for a limited-quantity hauling exemption, if the
generator or health care professional meets specified
requirements (HSC �118030).
g) Establishes a system to permit and oversee medical waste
treatment facilities (HSC �118130 et seq.).
FISCAL EFFECT : Unknown.
COMMENTS :
Need for the bill : According to the author, "Under existing
law, pharmaceutical drugs can be sent to health care facilities
through standard 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
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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. It is my
understanding that administrative agencies cannot make this
change without legislation."
Pharmaceutical waste in California : According to CalRecycle,
waste pharmaceuticals are expired (outdated), damaged,
contaminated, or otherwise unwanted medicines which are to be
discarded. They usually consist of prescription or
over-the-counter human or veterinary drugs that are no longer
needed or useable for their originally intended purpose.
According to DPH and DTSC, pharmaceutical waste is classified
either as hazardous waste, medical waste, or nonhazardous
(solid) waste. Which category a discarded pharmaceutical falls
into depends on its chemical, physical, and toxicological
properties. Proper classification is necessary for generators
to be in compliance with the laws regulating each waste type.
The California Code of Regulations dictates that the generator
of the waste is ultimately responsible for proper classification
of waste streams, and then, once it is classified, for managing
and disposing the waste according to the rule governing the
particular waste classification.
According DTSC, a discarded pharmaceutical may be identified as
a hazardous waste in California if it appears on a regulatory
list of hazardous wastes or exhibits ignitability, corrosively,
reactivity or toxicity. DTSC is authorized to regulate
pharmaceutical wastes to the extent they are regulated as
hazardous waste under RCRA. Hazardous waste must be managed and
disposed of in accordance with 40 Code of Federal Regulations
(CFR) 261 and Division 4.5, 22 California Code of Regulations
(CCR).
Some wastes that are not regulated under RCRA are nevertheless
identified as hazardous waste in California. Besides the
properties mentioned above, a number of additional factors can
cause a waste to exhibit the characteristic of toxicity under
California standards and thus be considered a hazardous waste in
California, including containing a substance listed in
California Code of Regulations Section 66261.2, being toxic when
inhaled, or being fatal to certain types of fish in laboratory
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tests. Pharmaceutical wastes that meet California's definition
of hazardous waste but not RCRA's definition, as well as
pharmaceutical wastes generated by people who are not regulated
under RCRA, are subject to the MWMA.
Non-RCRA, non-California hazardous waste is handled as solid
waste and may be disposed of in compliance with the disposal
requirements of the local treatment works and waste acceptance
criteria of the waste disposal facility.
Regulation of pharmaceutical waste under the MWMA :
Pharmaceutical wastes that must be managed according to the MWMA
are those that are classified as "California only hazardous
waste" by Chapter 11, Title 22, California Code of Regulations.
On January 1, 1997, the authority for regulating pharmaceutical
waste that is not RCRA hazardous waste but is California
hazardous waste was transferred from the DTSC to the Department
of Health Services (now DPH) under the MWMA.
If a pharmaceutical waste meets the criteria of a California
hazardous waste, it must be segregated in an appropriate
container, properly labeled, stored, manifested, transported and
incinerated at a regulated medical waste incinerator or
destroyed through another method approved by the DPH. The MWMA
prohibits a person from hauling medical waste unless the person
is either a registered hazardous waste hauler or has an approved
limited-quantity exemption.
Reverse distribution and transporting pharmaceutical waste: It
is common practice for pharmacies and other health care
facilities to return unused pharmaceuticals to the manufacturer
for credit or disposal. Health care facilities have the option
of hiring reverse distributors to manage their unused and/or
expired medication that could be returned to the manufacturer or
wholesaler for credit. The reverse distributor determines which
medications may be returned to the manufacturer or wholesaler
for credit and arranges for disposal of unused medications that
are waste. Once the unused pharmaceutical is determined to be
ineligible for credit, it becomes waste and must be managed as
such.
In California, reverse distributors are regulated by both the
BOP and the DPH. The BOP regulates activities involving
"dangerous drugs," as defined in BPC � 4022, which includes
prescription medications. Reverse distributors that intend to
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receive "outdated or nonsalable dangerous drugs," which could
include potentially creditable drugs, must register with the BOP
as "drug wholesalers" (BPC �4040.5, 4043 and 4160). However,
once a pharmaceutical is designated as "medical waste" pursuant
to the MWMA, it is regulated by the DPH (HSC �117690). For
purposes of the MWMA, the term "pharmaceutical" isn't restricted
to "dangerous drugs" as set forth in the BPC, but rather is
intended to cover all pharmaceuticals, including both
prescription and over-the-counter drugs (HSC �117747).
The MWMA requires that medical waste pharmaceuticals be sent to
reverse distributors via a licensed hazardous waste hauler (HSC
�118000). However, according to DPH's Self-Assessment Manual
for Proper Management of Medical Waste, pharmaceuticals that
have "intrinsic value" (such as outdated or otherwise unsalable
pharmaceuticals that are returned for credit) are not considered
"waste" and, thus, may be shipped to a reverse distributor via a
common carrier. Therefore, under current law, whether or not a
pharmaceutical is creditable determines whether it must be
transported via a registered waste hauler or is authorized to be
transported via common carrier. As is authorized under current
law for outdated or otherwise unsalable creditable
pharmaceuticals, this bill authorizes the transportation of
outdated or otherwise unsalable non-creditable pharmaceuticals,
which are designated as medical waste, via a common carrier.
Proposed amendment : This bill currently requires generators of
pharmaceutical waste to maintain specified tracking documents.
In order to ensure that waste pharmaceuticals reach their
intended destination, the Committee may wish to consider
requiring that a recipient of pharmaceutical waste also maintain
a copy of the required tracking documents.
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REGISTERED SUPPORT / OPPOSITION :
Support
EXP Pharmaceutical Services Corp. (sponsor)
American Federation of State, County, and Municipal Employees
(AFSME)
Bay Area Clean Water Agencies (BACWA)
California Product Stewardship Council
Californians Against Waste
City of Palo Alto
Clean Water Action
Fremont Chamber of Commerce
Los Angeles County Integrated Waste Management Task Force
Sierra Club California
Solid Waste Association of North America
Opposition
None received.
Analysis Prepared by : Shannon McKinney / E.S. & T.M. / (916)
319-3965