HomeMy WebLinkAboutMINUTES - 06262012 - C.47RECOMMENDATION(S):
SUPPORT AB 1442 (Wieckowski): Pharmaceutical Waste, a bill that would authorize the transportation of outdated
or otherwise unsalable non-creditable pharmaceuticals, which are designated as medical waste, via a common carrier
as recommended by the Legislation Committee.
FISCAL IMPACT:
The fiscal impact on the State of California has been estimated as follows:
1) Annual special fund costs of approximately $280,000 (equivalent to three positions) in 2012-13 through 2014-15 to
the Department of Public Health-the state agency that enforces medical waste transport-to coordinate with
stakeholders statewide, oversee rule-making process and develop regulations.
2) Annual special fund costs of approximately $159,000 (equivalent to two positions) to the department to review
exemption requests and ensure compliance with documentation requirements.
The fiscal impact on the County is unknown.
APPROVE OTHER
RECOMMENDATION OF CNTY ADMINISTRATOR RECOMMENDATION OF BOARD COMMITTEE
Action of Board On: 06/26/2012 APPROVED AS RECOMMENDED OTHER
Clerks Notes:
VOTE OF SUPERVISORS
AYE:John Gioia, District I Supervisor
Candace Andersen, District II
Supervisor
Mary N. Piepho, District III
Supervisor
Karen Mitchoff, District IV
Supervisor
Federal D. Glover, District V
Supervisor
Contact: L. DeLaney,
925-335-1097
I hereby certify that this is a true and correct copy of an action taken and entered on the minutes of the Board
of Supervisors on the date shown.
ATTESTED: June 26, 2012
David Twa, County Administrator and Clerk of the Board of Supervisors
By: June McHuen, Deputy
cc:
C. 47
To:Board of Supervisors
From:Legislation Committee
Date:June 26, 2012
Contra
Costa
County
Subject:Support AB 1442 (Wieckowski): Pharmaceutical Waste
BACKGROUND:
SUMMARY: Defines pharmaceutical waste for purposes of the Medical Waste Management Act. Authorizes a
medical waste generator or parent organization that employs health care professionals who generate
pharmaceuticals to apply to the enforcement agency for a pharmaceutical waste hauling exemption if the
generator meets specified requirements. Authorizes such waste to be transported by specified entities to include
the generator, health care professional, or a common carrier.
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 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."
The regulation of pharmaceutical waste falls under the Medical Waste Management Act (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. 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 California Department of Public Health (CDPH). 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.
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 Board of Pharmacy (BOP) and the CDPH. The BOP
regulates activities involving "dangerous drugs," as defined in Business and Professions Code (BPC) Section
4022, which includes prescription medications. Reverse distributors that intend to receive "outdated or nonsalable
dangerous drugs," which could include potentially creditable drugs, must register with the BOP as "drug
wholesalers" (BPC Sections 4040.5, 4043 and 4160). However, once a pharmaceutical is designated as "medical
waste" pursuant to the MWMA, it is regulated by the CDPH (HSC Section 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 Section 117747).
The MWMA requires that medical waste pharmaceuticals be sent to reverse distributors via a licensed hazardous
waste hauler (HSC Section 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.
DISPOSITION: Pending
LOCATION: SENATE
At its June 7, 2012 meeting, the Legislation Committee reviewed this bill and recommends that the Board of
Supervisors take a position of "support."
CONSEQUENCE OF NEGATIVE ACTION:
If the Board does not take a position on this bill, it will not have an official position from which to advocate.
CHILDREN'S IMPACT STATEMENT:
ATTACHMENTS
Assembly Appropriation Analysis for AB 1442
AB 1442 Bill Text
AMENDED IN ASSEMBLY MARCH 27, 2012
AMENDED IN ASSEMBLY FEBRUARY 6, 2012
california legislature—2011–12 regular session
ASSEMBLY BILL No. 1442
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Introduced by Assembly Member Wieckowski
(Coauthor: Coauthors:Assembly Member Members Allen and
Williams)
January 4, 2012
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An act to amend Sections 117935, 117945, 117960, 118000, 118040,
and 118165 of, and to add Sections 117637, 117748, and 118032 to,
the Health and Safety Code, relating to pharmaceutical waste.
legislative counsel’s digest
AB 1442, as amended, Wieckowski.Pharmaceutical waste.
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 would define pharmaceutical waste for purposes of the
Medical Waste Management Act, and would authorize a medical waste
generator or parent organization that employs health care professionals
who generate pharmaceuticals to apply to the enforcement agency for
a pharmaceutical waste hauling exemption if the generator, health care
professional, or parent organization retains specified documentation
and meets specified requirements and if the facility receiving the medical
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waste retains specified documentation. The bill would authorize
pharmaceutical waste to be transported by the generator or 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. By expanding the definition of a
crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the state.
Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act
for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
The people of the State of California do enact as follows:
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SECTION 1.Section 117637 is added to the Health and Safety
Code, to read:
117637.“Common carrier” means 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 (Division 14.85
(commencing with Section 34600) of the Vehicle Code) and, if
applicable, a carrier identification number issued by the Department
of the California Highway Patrol pursuant to Section 34507.5 of
the Vehicle Code.
SEC. 2.Section 117748 is added to the Health and Safety Code,
to read:
117748.(a) “Pharmaceutical waste” means any pharmaceutical,
as defined in Section 117747, that for any reason may no longer
be sold or dispensed for use as a drug.
(b) For purposes of this part, “pharmaceutical waste” does not
include any pharmaceutical that still has potential value to the
generator because it is being returned to a reverse distributor, as
defined in Section 4040.5 of the Business and Professions Code,
that is licensed both as a wholesaler of dangerous drugs by the
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California State Board of Pharmacy pursuant to Section 4160 of
the Business and Professions Code and as a permitted transfer
station pursuant to Section 117775, for possible manufacturer
credit.
SEC. 3.Section 117935 of the Health and Safety Code is
amended to read:
117935.Any small quantity generator required to register with
the enforcement agency pursuant to Section 117930 shall file with
the enforcement agency a medical waste management plan, on
forms prescribed by the enforcement agency containing, but not
limited to, all of the following:
(a) The name of the person.
(b) The business address of the person.
(c) The type of business.
(d) The types, and the estimated average monthly quantity, of
medical waste generated.
(e) The type of treatment used onsite.
(f) The name and business address of the registered hazardous
waste hauler used by the generator for backup treatment and
disposal, for waste when the onsite treatment method is not
appropriate due to the hazardous or radioactive characteristics of
the waste,, the name of the registered hazardous waste hauler used
by the generator to have untreated medical waste removed for
treatment and disposal, and, if applicable, the name of the common
carrier used by the generator to transport pharmaceutical waste
offsite for treatment and disposal pursuant to Section 118032.
(g) A statement indicating that the generator is hauling the
medical waste generated in his or her business pursuant to Section
118030 and the name and any business address of the treatment
and disposal facilities to which the waste is being hauled, if
applicable.
(h) The name and business address of the registered hazardous
waste hauler service provided by the building management to
which the building tenants may subscribe or are required by the
building management to subscribe and the name and business
address of the treatment and disposal facilities used, if applicable.
(i) A statement certifying that the information provided is
complete and accurate.
SEC. 4.Section 117945 of the Health and Safety Code is
amended to read:
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117945.Small quantity generators who are not required to
register pursuant to this chapter shall maintain on file in their office
all of following:
(a) An information document stating how the generator contains,
stores, treats, and disposes of any medical waste generated through
any act or process of the generator.
(b) Records of any medical waste transported offsite for
treatment and disposal, including the quantity of waste transported,
the date transported, the name of the registered hazardous waste
hauler or individual hauling the waste pursuant to Section 118030,
and, if applicable, the name of the common carrier transporting
pharmaceutical waste pursuant to Section 118032. The small
quantity generator shall maintain these records for not less than
two years.
SEC. 5.Section 117960 of the Health and Safety Code is
amended to read:
117960.Any large quantity generator required to register with
the enforcement agency pursuant to Section 117950 shall file with
the enforcement agency a medical waste management plan, on
forms prescribed by the enforcement agency containing, but not
limited to, all of the following:
(a) The name of the person.
(b) The business address of the person.
(c) The type of business.
(d) The types, and the estimated average monthly quantity, of
medical waste generated.
(e) The type of treatment used onsite, if applicable. For
generators with onsite medical waste treatment facilities, including
incinerators or steam sterilizers or other treatment facilities as
determined by the enforcement agency, the treatment capacity of
the onsite treatment facility.
(f) The name and business address of the registered hazardous
waste hauler used by the generator to have untreated medical waste
removed for treatment, if applicable, and, if applicable, the name
and business address of the common carrier transporting
pharmaceutical waste pursuant to Section 118032.
(g) The name and business address of the registered hazardous
waste hauler service provided by the building management to
which the building tenants may subscribe or are required by the
building management to subscribe, if applicable.
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(h) The name and business address of the offsite medical waste
treatment facility to which the medical waste is being hauled, if
applicable.
(i) An emergency action plan complying with regulations
adopted by the department.
(j) A statement certifying that the information provided is
complete and accurate.
SEC. 6.Section 118000 of the Health and Safety Code is
amended to read:
118000.(a) Except as otherwise exempted pursuant to Section
118030 or 118032, all medical waste transported to an offsite
medical waste treatment facility shall be transported in accordance
with this chapter by a registered hazardous waste transporter issued
a registration certificate pursuant to Chapter 6 (commencing with
Section 118025) and Article 6.5 (commencing with Section
25167.1) of Chapter 6.5 of Division 20. A hazardous waste
transporter transporting medical waste shall have a copy of the
transporter’s valid hazardous waste transporter registration
certificate in the transporter’s possession while transporting
medical waste. The transporter shall show the certificate, upon
demand, to any enforcement agency personnel or authorized
employee of the Department of the California Highway Patrol.
(b) Except for small quantity generators transporting medical
waste pursuant to Section 118030 or small quantity generators or
common carriers transporting pharmaceutical waste pursuant to
Section 118032, medical waste shall be transported to a permitted
offsite medical waste treatment facility or a permitted transfer
station in leak-resistant and fully enclosed rigid secondary
containers that are then loaded into an enclosed cargo body.
(c) A person shall not transport medical waste in the same
vehicle with other waste unless the medical waste is separately
contained in rigid containers or kept separate by barriers from
other waste, or unless all of the waste is to be handled as medical
waste in accordance with this part.
(d) Medical waste shall only be transported to a permitted
medical waste treatment facility, or to a transfer station or another
registered generator for the purpose of consolidation before
treatment and disposal, pursuant to this part.
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(e) Facilities for the transfer of medical waste shall be annually
inspected and issued permits in accordance with the regulations
adopted pursuant to this part.
(f) Any persons manually loading or unloading containers of
medical waste shall be provided by their employer at the beginning
of each shift with, and shall be required to wear, clean and
protective gloves and coveralls, changeable lab coats, or other
protective clothing. The department may require, by regulation,
other protective devices appropriate to the type of medical waste
being handled.
SEC. 7.Section 118032 is added to the Health and Safety Code,
to read:
118032.A medical waste generator or parent organization that
employs health care professionals who generate pharmaceutical
waste may 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:
(1) If the generator or parent organization is a small quantity
generator required to register pursuant to Chapter 4 (commencing
with Section 117915), a medical waste management plan prepared
pursuant to Section 117935.
(2) If the generator or parent organization is a small quantity
generator not required to register pursuant to Chapter 4
(commencing with Section 117915), the information document
maintained pursuant to subdivision (a) of Section 117945.
(3) If the generator or parent organization is a large quantity
generator, a medical waste management plan prepared pursuant
to Section 117960.
(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.
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(c) Except as provided in subdivision (d), the generator
maintains and the facility receiving the medical waste maintain a
tracking document, as specified in Section 118040.
(d) (1) Notwithstanding subdivision (c), if a health care
professional who generates pharmaceutical waste returns the
pharmaceutical waste to the parent organization for the purpose
of consolidation before treatment and disposal over a period of
time, a single-page form or multiple entry log may be substituted
for the tracking document, if the form or log contains all of the
following information:
(A) The name of the person transporting the pharmaceutical
waste.
(B) The number of containers of pharmaceutical waste. This
clause does not require any generator to maintain a separate
medical waste container for every patient or to maintain records
as to the specified source of the pharmaceutical waste in any
container.
(C) The date that the pharmaceutical waste was returned.
(2) The form or log described in paragraph (1) shall be
maintained in the files of the health care professional who
generates the pharmaceutical waste and the parent organization
or another health care facility that receives the waste.
(2)
(3) This subdivision 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, provided the form or log meets
the requirements specified in paragraphs (1) and (2).
SEC. 8.Section 118040 of the Health and Safety Code is
amended to read:
118040.(a) Except with regard to sharps waste consolidated
by a home-generated sharps consolidation point approved pursuant
to Section 117904, a hazardous waste transporter or generator
transporting medical waste shall maintain a completed tracking
document of all medical waste removed for treatment or disposal.
A hazardous waste transporter or generator who transports medical
waste to a facility, other than the final medical waste treatment
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facility, shall also maintain tracking documents which show the
name, address, and telephone number of the medical waste
generator, for purposes of tracking the generator of medical waste
when the waste is transported to the final medical waste treatment
facility. At the time that the medical waste is received by a
hazardous waste transporter, the transporter shall provide the
medical waste generator with a copy of the tracking document for
the generator’s medical waste records. The transporter or generator
transporting medical waste shall maintain its copy of the tracking
document for three years.
(b) The tracking document shall include, but not be limited to,
all of the following information:
(1) The name, address, telephone number, and registration
number of the transporter, unless transported pursuant to Section
118030.
(2) The type of medical waste transported and the quantity or
aggregate weight of medical waste transported.
(3) The name, address, and telephone number of the generator.
(4) The name, address, telephone number, permit number, and
the signature of an authorized representative of the permitted
facility receiving the medical waste.
(5) The date that the medical waste is collected or removed
from the generator’s facility, the date that the medical waste is
received by the transfer station, the registered large quantity
generator, or point of consolidation, if applicable, and the date that
the medical waste is received by the treatment facility.
(c) Any hazardous waste transporter or generator transporting
medical waste in a vehicle shall have a tracking document in his
or her possession while transporting the medical waste. The
tracking document shall be shown upon demand to any
enforcement agency personnel or officer of the Department of the
California Highway Patrol. If the medical waste is transported by
rail, vessel, or air, the railroad corporation, vessel operator, or
airline shall enter on the shipping papers any information
concerning the medical waste that the enforcement agency may
require.
(d) A hazardous waste transporter or a generator transporting
medical waste shall provide the facility receiving the medical waste
with the original tracking document.
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(e) Each hazardous waste transporter and each medical waste
treatment facility shall provide tracking data periodically and in a
format as determined by the department.
(f) Medical waste transported out of state shall be consigned
to a permitted medical waste treatment facility in the receiving
state. If there is no permitted medical waste treatment facility in
the receiving state or if the medical waste is crossing an
international border, the medical waste shall be treated in
accordance with Chapter 8 (commencing with Section 118215)
prior to being transported out of the state.
SEC. 9.Section 118165 of the Health and Safety Code is
amended to read:
118165.On and after April 1, 1991, all persons operating a
medical waste treatment facility shall maintain individual records
for a period of three years and shall report or submit to the
enforcement agency upon request, all of the following information:
(a) The type of treatment facility and its capacity.
(b) All treatment facility operating records.
(c) Copies of the tracking documents for all medical waste it
receives for treatment from offsite generators, hazardous waste
haulers, or, pursuant to Section 118032, common carriers.
SEC. 10.No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of
the Government Code, or changes the definition of a crime within
the meaning of Section 6 of Article XIII B of the California
Constitution.
O
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2011 CA A 1442: Bill Analysis - Assembly Appropriations Committee - 04/18/2012
BILL ANALYSIS
Date of Hearing: April 18, 2012
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 1442 (Wieckowski) - As Amended: March 27, 2012
Policy Committee: Environmental Safety and Toxic Materials
Vote: 8-0
Urgency: No
State Mandated Local Program: Yes
Reimbursable: No
SUMMARY
This bill authorizes a pharmaceutical waste hauling exemption that allows pharmaceutical waste to be transported according to
requirements that are less stringent than those applicable to medical waste.
Specifically, this bill:
1) Defines pharmaceutical waste as any pharmaceutical that may no longer be sold or dispensed as a drug.
2) Creates new documentation requirements of medical waste generators who use a common carrier to transport pharmaceutical
waste offsite for treatment and disposal.
3) Authorizes a medical waste generator to apply for an exemption from medical waste requirements so as to allow pharmaceutical
waste to be transported by a common carrier.
FISCAL EFFECT
1) Annual special fund costs of approximately $280,000 (equivalent to three positions) in 2012-13 through 2014-15 to the
Department of Public Health-the state agency that enforces medical waste transport-to coordinate with stakeholders statewide, oversee
rulemaking process and develop regulations.
2) Annual special fund costs of approximately $159,000 (equivalent to two positions) to the department to review exemption
requests and ensure compliance with documentation requirements.
COMMENTS
1) Rationale. The author notes that new pharmaceuticals, as well as unused pharmaceuticals, may be shipped by standard common
carrier transport. The author further notes that current law classifies pharmaceutical waste, such as expired or otherwise unusable
medications, as medical waste, which generally must be treated, for transport purposes, as hazardous waste. The author contends this
stringent shipping requirement creates costs for hospitals, pharmacies and other medical facilities without increasing public health or
safety.
2) Background. The California Medical Waste Management Act defines certain types of waste comprised of pharmaceuticals a
biohazardous waste, which must be handled and transported as a hazardous waste, consistent with the California Hazardous
Substances Act (CHSA). According to the Department of Toxic Substance Control, the state agency charged with implementing the
CHSA, hazardous waste can be transported only by a registered hazardous waste hauler and compliant with stringent handling
requirements. According to DPH, which enforces requirements on the transport of medical waste, there are nearly 11,000 entities in 28
counties that could apply for the exemption to medical waste transport requirement provided by this bill.
3) Support. This bill is supported by EXP Pharmaceutical Services (sponsor), the California Product Stewardship Council and several
other organizations.
4) There is no formal opposition registered to this bill.
Analysis Prepared by: Jay Dickenson / APPR. / (916) 319-2081
Copyright (c) 2012 State Net. All rights reserved.
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