BILL NUMBER: SB 423 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 21, 2016
AMENDED IN SENATE AUGUST 31, 2015
AMENDED IN SENATE JULY 6, 2015
AMENDED IN SENATE JUNE 3, 2015
INTRODUCED BY Senator Bates
FEBRUARY 25, 2015
An act to add and repeal Article 11.2 (commencing with
Section 25230) of Chapter 6.5 of Division 20 of amend,
repeal, and add Section 118215 of, and to add and repeal Section
118216 of, the Health and Safety Code, relating to hazardous
waste, and declaring the urgency thereof, to take effect
immediately. waste.
LEGISLATIVE COUNSEL'S DIGEST
SB 423, as amended, Bates. Retail nonprescription surplus
products: determinations for reuse. Pharmaceutical
and consumer product waste: management.
Existing law, the Medical Waste Management Act, administered by
the State Department of Public Health, regulates the management,
handling, and disposal of medical waste, as defined, including
pharmaceutical waste. Existing law requires a person generating
or treating medical waste to ensure that the medical waste is treated
by a specified method, thereby rendering it a solid waste, before
disposal, except in prescribed circumstances. Existing law also
provides for regulation of the disposition of hazardous
waste by the Department of Toxic Substances Control. A violation of
these provisions is a crime.
This bill, until January 1, 2022, would establish criteria to be
followed for the handling and management of retail nonprescription
pharmaceutical surplus products, as defined, if a reasonable
determination for reuse has been made or when a reasonable
determination for reuse cannot be made but the product has been
recalled as required by law. The bill would authorize the State
Department of Public Health to adopt regulations as deemed necessary
to establish standards for the proper and safe handling of retail
nonprescription pharmaceutical surplus products.
This bill, until January 1, 2022, would require a pharmaceutical
that is offered for sale without a prescription, upon discard, to be
managed in accordance the hazardous waste provisions if the
pharmaceutical is a hazardous waste, or, if the pharmaceutical is not
a hazardous waste, in accordance with the above-described medical
waste provisions or specified solid waste provisions.
Because a violation of these provisions would be a crime, this
bill would impose a state-mandated local program.
This bill would require the Department of Toxic Substances Control
to convene a Retail Waste Working Group, as prescribed, to identify
regulatory and policy directives that need clarification or
specification when applied to consumer products and to adopt
consensus recommendations to facilitate and increase sustainable
practices and waste reduction opportunities for consumer products and
to encourage safe and efficient options for managing the flow of
surplus household consumer products through the reverse supply chain.
The bill would require the working group to identify a list of
issues for discussion and resolution by March 1, 2017, and to report
consensus recommendations to the Legislature by June 1, 2017.
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.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: 2/3 majority . Appropriation:
no. Fiscal committee: yes. State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 118215 of the Health
and Safety Code is amended to read:
118215. (a) Except as provided in subdivisions (b) and
(c), (c) and Section 118216, a person generating
or treating medical waste shall ensure that the medical waste is
treated by one of the following methods, thereby rendering it solid
waste, as defined in Section 40191 of the Public Resources Code,
prior to before disposal:
(1) (A) Incineration at a permitted medical waste treatment
facility in a controlled-air, multichamber incinerator, or other
method of incineration approved by the department which
that provides complete combustion of the waste
into carbonized or mineralized ash.
(B) Treatment with an alternative technology approved pursuant to
paragraph (3), which, due to the extremely high temperatures of
treatment in excess of 1300 1,300
degrees Fahrenheit, has received express approval from the
department.
(2) Steam sterilization at a permitted medical waste treatment
facility or by other sterilization, in accordance with all of the
following operating procedures for steam sterilizers or other
sterilization:
(A) Standard written operating procedures shall be established for
biological indicators, or for other indicators of adequate
sterilization approved by the department, for each steam sterilizer,
including time, temperature, pressure, type of waste, type of
container, closure on container, pattern of loading, water content,
and maximum load quantity.
(B) Recording or indicating thermometers shall be checked during
each complete cycle to ensure the attainment of 121
Centigrade (250 121 degrees
centigrade (250 degrees Fahrenheit) for at least one-half hour,
depending on the quantity and density of the load, to achieve
sterilization of the entire load. Thermometers, thermocouples, or
other monitoring devices identified in the facility operating plan
shall be checked for calibration annually. Records of the calibration
checks shall be maintained as part of the facility's files and
records for a period of two years or for the period specified in the
regulations.
(C) Heat-sensitive tape, or another method acceptable to the
enforcement agency, shall be used on each biohazard bag or sharps
container that is processed onsite to indicate that the waste went
through heat treatment. If the biohazard bags or sharps containers
are placed in a large liner bag within the autoclave for treatment,
heat-sensitive tape or another method acceptable to the enforcement
agency only needs to be placed on the liner bag and not on every
hazardous waste bag or sharps container being treated.
(D) The biological indicator Geobacillus stearothermophilus, or
other indicator of adequate sterilization as approved by the
department, shall be placed at the center of a load processed under
standard operating conditions at least monthly to confirm the
attainment of adequate sterilization conditions.
(E) Records of the procedures specified in subparagraphs (A), (B),
and (D) shall be maintained for a period of not less than two years.
(3) (A) Other alternative medical waste treatment methods
which that are both of the following:
(i) Approved by the department.
(ii) Result in the destruction of pathogenic
micro-organisms. microorganisms.
(B) Any alternative medical waste treatment method proposed to the
department shall be evaluated by the department and either approved
or rejected pursuant to the criteria specified in this subdivision.
(b) Fluid blood or fluid blood products may be discharged to a
public sewage system without treatment if its discharge is consistent
with waste discharge requirements placed on the public sewage system
by the California regional water quality control board with
jurisdiction.
(c) (1) A medical waste that is a biohazardous laboratory waste,
as defined in subparagraph (B) of paragraph (1) of subdivision (b) of
Section 117690, may be treated by a chemical disinfection if the
waste is liquid or semiliquid and the chemical disinfection method is
recognized by the National Institutes of Health, the Centers for
Disease Control and Prevention, or the American Biological Safety
Association, and if the use of chemical disinfection as a treatment
method is identified in the site's medical waste management plan.
(2) If the waste is not treated by chemical disinfection, in
accordance with paragraph (1), the waste shall be treated by one of
the methods specified in subdivision (a).
(3) Following treatment by chemical disinfection, the medical
waste may be discharged to the public sewage system if the discharge
is consistent with waste discharge requirements placed on the public
sewage system by the California regional water quality
control board, and the discharge is in compliance with the
requirements imposed by the owner or operator of the public sewage
system. If the chemical disinfection of the medical waste causes the
waste to become a hazardous waste, the waste shall be managed in
accordance with the requirements of Chapter 6.5 (commencing with
Section 25100) of Division 20.
(d) This section shall remain in effect only until January 1,
2022, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2022, deletes or extends
that date.
SEC. 2. Section 118215 is added to the
Health and Safety Code , to read:
118215. (a) Except as provided in subdivisions (b) and (c), a
person generating or treating medical waste shall ensure that the
medical waste is treated by one of the following methods, thereby
rendering it solid waste, as defined in Section 40191 of the Public
Resources Code, before disposal:
(1) (A) Incineration at a permitted medical waste treatment
facility in a controlled-air, multichamber incinerator, or other
method of incineration approved by the department that provides
complete combustion of the waste into carbonized or mineralized ash.
(B) Treatment with an alternative technology approved pursuant to
paragraph (3), which, due to the extremely high temperatures of
treatment in excess of 1,300 degrees Fahrenheit, has received express
approval from the department.
(2) Steam sterilization at a permitted medical waste treatment
facility or by other sterilization, in accordance with all of the
following operating procedures for steam sterilizers or other
sterilization:
(A) Standard written operating procedures shall be established for
biological indicators, or for other indicators of adequate
sterilization approved by the department, for each steam sterilizer,
including time, temperature, pressure, type of waste, type of
container, closure on container, pattern of loading, water content,
and maximum load quantity.
(B) Recording or indicating thermometers shall be checked during
each complete cycle to ensure the attainment of 121 degrees
centigrade (250 degrees Fahrenheit) for at least one-half hour,
depending on the quantity and density of the load, to achieve
sterilization of the entire load. Thermometers, thermocouples, or
other monitoring devices identified in the facility operating plan
shall be checked for calibration annually. Records of the calibration
checks shall be maintained as part of the facility's files and
records for a period of two years or for the period specified in the
regulations.
(C) Heat-sensitive tape, or another method acceptable to the
enforcement agency, shall be used on each biohazard bag or sharps
container that is processed onsite to indicate that the waste went
through heat treatment. If the biohazard bags or sharps containers
are placed in a large liner bag within the autoclave for treatment,
heat-sensitive tape or another method acceptable to the enforcement
agency only needs to be placed on the liner bag and not on every
hazardous waste bag or sharps container being treated.
(D) The biological indicator Geobacillus stearothermophilus, or
other indicator of adequate sterilization as approved by the
department, shall be placed at the center of a load processed under
standard operating conditions at least monthly to confirm the
attainment of adequate sterilization conditions.
(E) Records of the procedures specified in subparagraphs (A), (B),
and (D) shall be maintained for a period of not less than two years.
(3) (A) Other alternative medical waste treatment methods that are
both of the following:
(i) Approved by the department.
(ii) Result in the destruction of pathogenic microorganisms.
(B) Any alternative medical waste treatment method proposed to the
department shall be evaluated by the department and either approved
or rejected pursuant to the criteria specified in this subdivision.
(b) Fluid blood or fluid blood products may be discharged to a
public sewage system without treatment if its discharge is consistent
with waste discharge requirements placed on the public sewage system
by the California regional water quality control board with
jurisdiction.
(c) (1) A medical waste that is a biohazardous laboratory waste,
as defined in subparagraph (B) of paragraph (1) of subdivision (b) of
Section 117690, may be treated by a chemical disinfection if the
waste is liquid or semiliquid and the chemical disinfection method is
recognized by the National Institutes of Health, the Centers for
Disease Control and Prevention, or the American Biological Safety
Association, and if the use of chemical disinfection as a treatment
method is identified in the site's medical waste management plan.
(2) If the waste is not treated by chemical disinfection, in
accordance with paragraph (1), the waste shall be treated by one of
the methods specified in subdivision (a).
(3) Following treatment by chemical disinfection, the medical
waste may be discharged to the public sewage system if the discharge
is consistent with waste discharge requirements placed on the public
sewage system by the California regional water quality control board,
and the discharge is in compliance with the requirements imposed by
the owner or operator of the public sewage system. If the chemical
disinfection of the medical waste causes the waste to become a
hazardous waste, the waste shall be managed in accordance with the
requirements of Chapter 6.5 (commencing with Section 25100) of
Division 20.
(d) This section shall become operative on January 1, 2022.
SEC. 3. Section 118216 is added to the
Health and Safety Code , to read:
118216. (a) Notwithstanding Section 117690, a pharmaceutical that
is offered for sale without a prescription shall, upon discard, be
managed in accordance with Chapter 6.5 (commencing with Section
25100) of Division 20 if it is a hazardous waste as defined in
Section 25117 and implementing regulations. If the pharmaceutical is
not a hazardous waste, it shall be managed in accordance with one of
the following:
(1) Section 118215.
(2) Provisions relating to solid waste pursuant to Division 30
(commencing with Section 40000) of the Public Resources Code.
(b) This section shall remain in effect only until January 1,
2022, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2022, deletes or extends
that date.
SEC. 4. (a) The Department of
Toxic Substances Control shall convene a Retail Waste Working Group
comprised of representatives of large retailers, small retailers,
district attorneys, certified unified program agencies, nongovernment
organizations, the State Department of Public Health, manufacturers,
reverse distributors, and other stakeholders to do both of the
following:
(1) Identify regulatory and policy directives that need
clarification or specification when applied to consumer products.
(2) Adopt consensus recommendations to facilitate and increase
sustainable practices and waste reduction opportunities for consumer
products and to encourage safe and efficient options for managing the
flow of surplus household consumer products through the reverse
supply chain.
(b) By March 1, 2017, the Retail Waste Working Group shall
identify a list of issues for discussion and resolution and,
thereafter, shall meet regularly to assist and advise the
Legislature, and shall report the consensus recommendations to the
Legislature by June 1, 2017.
SEC. 5. 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.
SECTION 1. Article 11.2 (commencing with
Section 25230) is added to Chapter 6.5 of Division 20 of the Health
and Safety Code, to read:
Article 11.2. Nonprescription Pharmaceutical Surplus Products
25230. (a) The Legislature finds and declares that this section
is intended to address the unique circumstances associated with the
management of retail nonprescription pharmaceutical surplus products
that potentially can be safely diverted from the waste stream for
reuse, if appropriate. The Legislature further declares that this
section shall not be construed to set a precedent applicable to the
management, including disposal, of other hazardous or medical wastes.
(b) For purposes of this section, the following definitions shall
apply:
(1) "Retail nonprescription pharmaceutical surplus product" means
a pharmaceutical, as that term is defined in Section 117747, that may
be sold without a prescription and that is labeled for use by the
consumer in accordance with the requirements of the laws and rules of
this state and the federal government, defined as a nonprescription
drug in Article 2 (commencing with Section 4015) of Chapter 9 of
Division 2 of the Business and Professions Code, in which a waste
generator has made a reasonable determination for reuse. A retail
nonprescription pharmaceutical surplus product does not include waste
that is subject to regulation as a hazardous waste under the federal
Resource Conservation and Recovery Act of 1976, as amended (42
U.S.C. Sec. 6901 et seq.).
(2) "Reasonable determination for reuse" means, upon removal of a
retail nonprescription pharmaceutical surplus product from sale, a
generator who has evaluated the product and makes a finding that the
product meets all of the following criteria:
(A) The product is in unadulterated packaging.
(B) The product and packaging are in a condition that is suitable
for resale.
(C) The product is not designated for disposal by the manufacturer
or the manufacturer's agent.
(D) The product is otherwise eligible for liquidation or donation.
(3) "Reverse distributor" or "reverse distribution center" has the
same meaning as set forth in Section 4040.5 of the Business and
Professions Code that satisfies all of the following:
(A) Is licensed as a wholesaler of dangerous drugs by the
California State Board of Pharmacy pursuant to Section 4160 of the
Business and Professions Code.
(B) Is permitted by the State Department of Public Health as a
transfer station, if the reverse distributor is located within the
State of California.
(C) Is registered with the Department of Toxic Substances Control
and any other appropriate state and local agencies as a hazardous
waste generator, transfer facility, or storage facility.
(D) Complies with handling, storage, training, emergency response,
and recordkeeping requirements, and any other applicable
requirements.
(c) Notwithstanding Sections 25189.5, 25201, and 117747, if a
reasonable determination for reuse has been made, a retail
nonprescription pharmaceutical surplus product may be handled in
accordance with all of the following:
(1) The retail nonprescription pharmaceutical surplus product
shall be transported to a reverse distributor or reverse distribution
center for any of the following purposes:
(A) Evaluating the manufacturer's or supplier's credit or other
financial reconciliation.
(B) Liquidation.
(C) Donation.
(D) Transferring back to a manufacturer, distributor, or supplier,
or its respective agent.
(2) The retail nonprescription pharmaceutical surplus product
shall be transported with a tracking document that identifies all of
the following information:
(A) The product, the UPC label, and the lot number.
(B) Name, address, and telephone number of the generator of the
waste.
(C) Name, address, and telephone number of the reverse distributor
or reverse distribution center receiving the shipment.
(D) The purpose for which the retail nonprescription
pharmaceutical surplus product is being shipped to the reverse
distributor or reverse distribution center.
(3) Shipments of retail nonprescription pharmaceutical surplus
products to a reverse distributor or a reverse distribution center
shall be made via a transporter registered with the United States
Department of Transportation Federal Motor Carrier Safety
Administration. Transporters shall use due diligence to ensure safe
handling, which includes, but is not limited to, ensuring that the
packaging does not become damaged or adulterated during shipment and
that the shipment is handled in appropriate moisture and temperature
conditions.
(4) The reverse distributor or reverse distribution center shall
do all of the following:
(A) Maintain the specified tracking documents for a period of
three years following receipt date of a shipment and shall make those
documents available for inspection by any applicable enforcement
agencies.
(B) Submit a hazardous materials business plan to the appropriate
state and local agencies, as required by Article 1 (commencing with
Section 25500) of Chapter 6.95 and any regulations promulgated by
either the Department of Toxic Substances Control or any certified
unified program agency.
(d) A retail nonprescription pharmaceutical surplus product that
has been transported to a reverse distributor or reverse distribution
center for any of the purposes listed in paragraph (1) of
subdivision (c) shall not be stored or held at the reverse
distributor or reverse distribution center for more than 364 calendar
days. A retail nonprescription pharmaceutical surplus product held
or stored for 365 or more days shall immediately be considered waste
and, if hazardous, managed in accordance with applicable federal and
state hazardous waste management laws and regulations.
(e) Notwithstanding Sections 25189.5, 25201, and 117747, the
provisions of subdivision (c) may be used for a retail
nonprescription pharmaceutical surplus product for which a reasonable
determination for reuse cannot be made if the product has been
recalled as required by law, including safety recalls for secure
destruction.
(f) The State Department of Public Health may adopt regulations as
deemed necessary to establish standards for the proper and safe
handling of retail nonprescription pharmaceutical surplus products.
(g) A facility that elects to manage its retail nonprescription
pharmaceutical surplus products pursuant to this article is not
subject to regulation of those products under either the Medical
Waste Management Act (Part 14 (commencing with Section 117600) of
Division 104) or any other provision of this chapter.
(h) This article shall remain in effect only until January 1,
2022, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2022, deletes or extends
that date.
SEC. 2. 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.
SEC. 3. This act is an urgency statute
necessary for the immediate preservation of the public peace, health,
or safety within the meaning of Article IV of the Constitution and
shall go into immediate effect. The facts constituting the necessity
are:
In order to make statutory changes needed to address the unique
circumstances associated with the management, handling, and
reasonable determination of reuse or retail nonprescription
pharmaceutical surplus products as soon as possible, it is necessary
that this act take effect immediately.