Amended in Assembly June 21, 2016

Amended in Senate August 31, 2015

Amended in Senate July 6, 2015

Amended in Senate June 3, 2015

Senate Bill No. 423

Introduced by Senator Bates

February 25, 2015

An act to begin delete add and repeal Article 11.2 (commencing with Section 25230) of Chapter 6.5 of Division 20 of end delete begin insert amend, repeal, and add Section 118215 of, and to add and repeal Section 118216 of, end insert the Health and Safety Code, relating to hazardous begin delete waste, and declaring the urgency thereof, to take effect immediately. end delete begin insert waste. end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 423, as amended, Bates. begin delete Retail nonprescription surplus products: determinations for reuse. end delete begin insert Pharmaceutical and consumer product waste: management. end insert

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. begin insert 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. end insert Existing law also provides for begin insert regulation of end insert the disposition of hazardous waste by the Department of Toxic Substances Control. A violation of these provisions is a crime.

begin delete

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.

end delete begin insert

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.

end insert

Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.

begin insert

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.

end insert

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.

begin delete

This bill would declare that it is to take effect immediately as an urgency statute.

end delete

Vote:  begin delete ²⁄₃ end delete begin insert majority end insert . Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 118215 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

118215.  

(a) Except as provided in subdivisions (b) and begin delete (c), end delete
begin insert (c) and Section 118216, end insert 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, begin delete prior to end delete begin insert before end insert
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 begin delete which end delete begin insert that end insert
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 begin delete 1300 end delete begin insert 1,300 end insert 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 begin delete 121°
Centigrade (250° end delete begin insert 121 degrees centigrade (250 degrees end insert 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
begin delete which end delete begin insert that end insert are both of the following:

(i) Approved by the department.

(ii) Result in the destruction of pathogenic begin delete micro-organisms. end delete

begin insert microorganisms. end insert

(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
begin insert quality end insert 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.

begin insert

(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.

end insert

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 118215 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 118215. end insert   

(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.

end insert

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 118216 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 118216. end insert   

(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.

end insert

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert (a) end insert begin insert   end insert begin insert 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: end insert

begin insert

(1) Identify regulatory and policy directives that need
clarification or specification when applied to consumer products.

end insert begin insert

(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.

end insert begin insert

(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.

end insert

begin insert

begin insert SEC. 5. end insert   

end insert begin insert

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.

end insert

begin delete

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.

end delete