Amended in Senate June 24, 2015

Amended in Senate June 2, 2015

Amended in Assembly April 16, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 649

Introduced by Assembly Member Patterson

February 24, 2015

An act to amend Section 118215 of, and to add Sections 117748 and 118217 to, the Health and Safety Code, relating to medical waste.

LEGISLATIVE COUNSEL’S DIGEST

AB 649, as amended, Patterson. Medical waste: law enforcement drug takeback programs.

Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring medical waste to be treated by specified methods prior to disposal, including incineration in a controlled-air, multichamber incinerator, or other method of incineration approved by the State Department of Public Health that provides complete combustion of the waste into carbonized or mineralized ash.

This bill would include among those authorized treatment methods any alternative medical waste treatment solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, as defined, and would require this method to be evaluated and approved by the State Department of Public Health. The bill would require the department to complete the first evaluation begin delete and approval end delete of these alternative medical waste treatments begin delete solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, end delete by June 1, begin delete 2017. end delete begin insert 2017, and would require the department to consult with specified entities, including the Department of Toxic Substances Control and the State Air Resources Board, in the evaluation to ensure compliance with all other applicable environmental quality laws. end insert The bill would authorize a law enforcement agency that operates a prescription drug takeback program to utilize a pharmaceutical incinerator up to 4 times per year if the incinerator is evaluated and approved by the begin delete department. end delete begin insert department and complies with all other applicable federal and state laws and local ordinances. end insert

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

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

SECTION 1.  

Section 117748 is added to the Health and Safety
Code, to read:

117748.  

“Pharmaceutical incinerator” means a treatment device
that solely incinerates pharmaceutical waste, as defined in Section
117690, that renders the pharmaceutical waste as solid waste.

SEC. 2.  

Section 118215 of the Health and Safety Code is
amended 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, prior to 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 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 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° 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 are both of the following:

(i) Approved by the department.

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

(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.

(C) Any alternative medical waste treatment solely designed to
treat pharmaceutical waste, including a pharmaceutical incinerator,
shall be evaluated and approved by the department with regard to
the necessary treatment of pharmaceuticals. By June 1, 2017, the
department shall complete the first evaluation begin delete and approval end delete of
these alternative medical waste treatments, including a
pharmaceutical incinerator. begin insert In evaluating any alternative medical
waste treatment, the department shall consult with the State Water
Resources Control Board, the Department of Toxic Substances
Control, the State Air Resources Board, and local air quality
management districts to ensure compliance with all other
applicable environmental quality laws prior to approval of the
alternative medical waste treatment. end insert

(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
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.

SEC. 3.  

Section 118217 is added to the Health and Safety Code,
to read:

118217.  

A law enforcement agency that operates a prescription
drug takeback program may utilize up to four times per year a
pharmaceutical incinerator that is evaluated and approved by the
department pursuant to Section begin delete 118215. end delete begin insert 118215 and that complies
with all other applicable federal and state laws and local
ordinances. end insert