Amended in Senate June 2, 2015

Amended in Assembly April 16, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 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.begin insert The bill would require the department to complete the first evaluation and approval of these alternative medical waste treatments solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, by June 1, 2017.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 department.

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

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

P2    1

SECTION 1.  

Section 117748 is added to the Health and Safety
2Code
, to read:

3

117748.  

“Pharmaceutical incinerator” means a treatment device
4that solely incinerates pharmaceutical waste, as defined in Section
5117690, that renders the pharmaceutical waste as solid waste.

6

SEC. 2.  

Section 118215 of the Health and Safety Code is
7amended to read:

8

118215.  

(a) Except as provided in subdivisions (b) and (c), a
9person generating or treating medical waste shall ensure that the
10medical waste is treated by one of the following methods, thereby
11rendering it solid waste, as defined in Section 40191 of the Public
12Resources Code, prior to disposal:

13(1) (A) Incineration at a permitted medical waste treatment
14facility in a controlled-air, multichamber incinerator, or other
15method of incineration approved by the department which provides
16complete combustion of the waste into carbonized or mineralized
17ash.

18(B) Treatment with an alternative technology approved pursuant
19to paragraph (3), which, due to the extremely high temperatures
20of treatment in excess of 1300 degrees Fahrenheit, has received
21express approval from the department.

22(2) Steam sterilization at a permitted medical waste treatment
23facility or by other sterilization, in accordance with all of the
24following operating procedures for steam sterilizers or other
25sterilization:

26(A) Standard written operating procedures shall be established
27for biological indicators, or for other indicators of adequate
28sterilization approved by the department, for each steam sterilizer,
29including time, temperature, pressure, type of waste, type of
30container, closure on container, pattern of loading, water content,
31and maximum load quantity.

P3    1(B) Recording or indicating thermometers shall be checked
2during each complete cycle to ensure the attainment of 121°
3Centigrade (250° Fahrenheit) for at least one-half hour, depending
4on the quantity and density of the load, to achieve sterilization of
5the entire load. Thermometers, thermocouples, or other monitoring
6devices identified in the facility operating plan shall be checked
7for calibration annually. Records of the calibration checks shall
8be maintained as part of the facility’s files and records for a period
9of two years or for the period specified in the regulations.

10(C) Heat-sensitive tape, or another method acceptable to the
11enforcement agency, shall be used on each biohazard bag or sharps
12container that is processed onsite to indicate that the waste went
13through heat treatment. If the biohazard bags or sharps containers
14are placed in a large liner bag within the autoclave for treatment,
15heat-sensitive tape or another method acceptable to the enforcement
16agency only needs to be placed on the liner bag and not on every
17hazardous waste bag or sharps container being treated.

18(D) The biological indicator Geobacillus stearothermophilus,
19or other indicator of adequate sterilization as approved by the
20department, shall be placed at the center of a load processed under
21standard operating conditions at least monthly to confirm the
22attainment of adequate sterilization conditions.

23(E) Records of the procedures specified in subparagraphs (A),
24(B), and (D) shall be maintained for a period of not less than two
25years.

26(3) (A) Other alternative medical waste treatment methods
27which are both of the following:

28(i) Approved by the department.

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

30(B) Any alternative medical waste treatment method proposed
31to the department shall be evaluated by the department and either
32approved or rejected pursuant to the criteria specified in this
33subdivision.

34(C) Any alternative medical waste treatment solely designed to
35treat pharmaceutical waste, including a pharmaceutical incinerator,
36shall be evaluated and approved by the department with regard to
37the necessary treatment of pharmaceuticals.begin insert By June 1, 2017, the
38department shall complete the first evaluation and approval of
39these alternative medical waste treatments, including a
40pharmaceutical incinerator.end insert

P4    1(b) Fluid blood or fluid blood products may be discharged to a
2public sewage system without treatment if its discharge is
3consistent with waste discharge requirements placed on the public
4sewage system by the California regional water quality control
5board with jurisdiction.

6(c) (1) A medical waste that is a biohazardous laboratory waste,
7as defined in subparagraph (B) of paragraph (1) of subdivision (b)
8of Section 117690, may be treated by a chemical disinfection if
9the waste is liquid or semiliquid and the chemical disinfection
10method is recognized by the National Institutes of Health, the
11Centers for Disease Control and Prevention, or the American
12Biological Safety Association, and if the use of chemical
13disinfection as a treatment method is identified in the site’s medical
14waste management plan.

15(2) If the waste is not treated by chemical disinfection, in
16accordance with paragraph (1), the waste shall be treated by one
17of the methods specified in subdivision (a).

18(3) Following treatment by chemical disinfection, the medical
19waste may be discharged to the public sewage system if the
20discharge is consistent with waste discharge requirements placed
21on the public sewage system by the California regional water
22control board, and the discharge is in compliance with the
23requirements imposed by the owner or operator of the public
24sewage system. If the chemical disinfection of the medical waste
25causes the waste to become a hazardous waste, the waste shall be
26managed in accordance with the requirements of Chapter 6.5
27(commencing with Section 25100) of Division 20.

28

SEC. 3.  

Section 118217 is added to the Health and Safety Code,
29to read:

30

118217.  

A law enforcement agency that operates a prescription
31drug takeback program may utilize up to four times per year a
32pharmaceutical incinerator that is evaluated and approved by the
33department pursuant to Section 118215.



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