BILL NUMBER: SB 1966 CHAPTERED
BILL TEXT
CHAPTER 536
FILED WITH SECRETARY OF STATE SEPTEMBER 16, 1996
APPROVED BY GOVERNOR SEPTEMBER 14, 1996
PASSED THE SENATE AUGUST 22, 1996
PASSED THE ASSEMBLY AUGUST 20, 1996
AMENDED IN ASSEMBLY JUNE 18, 1996
AMENDED IN SENATE APRIL 9, 1996
INTRODUCED BY Senator Wright
FEBRUARY 23, 1996
An act to amend Section 25117.5 of, to amend and renumber Sections
25020.5, 25021.9, 25022.8, 25023.2, 25023.8, 25024, 25025.9, 25027,
25027.5, 25030.5, 25041, 25055, 25061, 25062.5, 25063, 25070.4,
25080, 25081, 25088, 25090, 25090.5, and 25090.6 of, and to add
Sections 117747 and 117924 to, the Health and Safety Code, relating
to medical waste.
LEGISLATIVE COUNSEL'S DIGEST
SB 1966, Wright. Medical waste.
Existing law, the Medical Waste Management Act, administered by
the State Department of Health Services, regulates the management and
handling of medical waste, as defined.
This bill would regulate the management and handling of waste
pharmaceuticals, as defined, under the act and specify that it is not
subject to the hazardous waste control laws.
The bill would also include, as medical waste under the act,
biohazardous waste that meets specified conditions.
The bill would require the department, when it is the enforcement
agency under the act, to impose and collect an annual medical waste
generator fee in an amount not to exceed $25 on small quantity
generators of medical waste, except for specified small quantity
generators and generators generating only specified biohazardous
waste.
The bill would make related changes in the act, renumber
provisions of the act in conformity with prior recodification, and
make various other technical and clarifying changes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 25020.5 of the Health and Safety Code is
amended and renumbered to read:
117635. "Biohazardous waste" means any of the following:
(a) Laboratory waste, including, but not limited to, all of the
following:
(1) Human or animal specimen cultures from medical and pathology
laboratories.
(2) Cultures and stocks of infectious agents from research and
industrial laboratories.
(3) Wastes from the production of bacteria, viruses, spores,
discarded live and attenuated vaccines used in human health care or
research, discarded animal vaccines, including Brucellosis and
Contagious Ecthyma, as identified by the department, and culture
dishes and devices used to transfer, inoculate, and mix cultures.
(b) Human surgery specimens or tissues removed at surgery or
autopsy, which are suspected by the attending physician and surgeon
or dentist of being contaminated with infectious agents known to be
contagious to humans.
(c) Animal parts, tissues, fluids, or carcasses suspected by the
attending veterinarian of being contaminated with infectious agents
known to be contagious to humans.
(d) Waste, which at the point of transport from the generator's
site, at the point of disposal, or thereafter, contains recognizable
fluid blood, fluid blood products, containers or equipment containing
blood that is fluid, or blood from animals known to be infected with
diseases which are highly communicable to humans.
(e) Waste containing discarded materials contaminated with
excretion, exudate, or secretions from humans or animals that are
required to be isolated by the infection control staff, the attending
physician and surgeon, the attending veterinarian, or the local
health officer, to protect others from highly communicable diseases
or diseases of animals that are highly communicable to humans.
(f) (1) Waste which is hazardous only because it is comprised of
human surgery specimens or tissues which have been fixed in
formaldehyde or other fixatives, or only because the waste is
contaminated through contact with, or having previously contained,
chemotherapeutic agents, including, but not limited to, gloves,
disposable gowns, towels, and intravenous solution bags and attached
tubing which are empty. A biohazardous waste which meets the
conditions of this paragraph is not subject to Chapter 6.5
(commencing with Section 25100) of Division 20.
(2) For purposes of this subdivision, "chemotherapeutic agent"
means an agent that kills or prevents the reproduction of malignant
cells.
(3) For purposes of this subdivision, a container, or inner liner
removed from a container, which previously contained a
chemotherapeutic agent, is empty if the container or inner liner
removed from the container has been emptied by the generator as much
as possible, using methods commonly employed to remove waste or
material from containers or liners, so that the following conditions
are met:
(A) If the material which the container or inner liner held is
pourable, no material can be poured or drained from the container or
inner liner when held in any orientation, including, but not limited
to, when tilted or inverted.
(B) If the material which the container or inner liner held is not
pourable, no material or waste remains in the container or inner
liner that can feasibly be removed by scraping.
(g) Waste that is hazardous only because it is comprised of
pharmaceuticals, as defined in Section 117747. Notwithstanding
subdivision (a) of Section 117690, medical waste includes
biohazardous waste that meets the conditions of this subdivision.
Biohazardous waste that meets the conditions of this subdivision is
not subject to Chapter 6.5 (commencing with Section 25100) of
Division 20.
SEC. 2. Section 25021.9 of the Health and Safety Code is amended
and renumbered to read:
117662. "Health care professional" means any person licensed or
certified pursuant to Division 2 (commencing with Section 500) of the
Business and Professions Code; any person licensed pursuant to the
Osteopathic Initiative Act, as set forth in Chapter 8 (commencing
with Section 3600) of Division 2 of the Business and Professions
Code, or pursuant to the Chiropractic Initiative Act, as set forth in
Chapter 2 (commencing with Section 1000) of Division 2 of the
Business and Professions Code; and any person certified pursuant to
Division 2.5 (commencing with Section 1797).
SEC. 3. Section 25022.8 of the Health and Safety Code is amended
and renumbered to read:
117680. "Large quantity generator" means a medical waste
generator that generates 200 or more pounds of medical waste in any
month of a 12-month period.
SEC. 4. Section 25023.2 of the Health and Safety Code is amended
and renumbered to read:
117690 (a) "Medical waste" means waste which meets both of the
following requirements:
(1) The waste is composed of waste which is generated or produced
as a result of any of the following actions:
(A) Diagnosis, treatment, or immunization of human beings or
animals.
(B) Research pertaining to the activities specified in
subparagraph (A).
(C) The production or testing of biologicals.
(D) The accumulation of properly contained home-generated sharps
waste that is brought by a patient, a member of the patient's family,
or by a person authorized by the enforcement agency, to a point of
consolidation approved by the enforcement agency pursuant to Section
117904 or authorized pursuant to Section 118147.
(2) The waste is either of the following:
(A) Biohazardous waste.
(B) Sharps waste.
(b) For purposes of this section, "biologicals" means medicinal
preparations made from living organisms and their products,
including, but not limited to, serums, vaccines, antigens, and
antitoxins.
SEC. 5. Section 25023.8 of the Health and Safety Code is amended
and renumbered to read:
117700. Medical waste does not include any of the following:
(a) Waste generated in food processing or biotechnology that does
not contain an infectious agent as defined in Section 117675.
(b) Waste generated in biotechnology that does not contain human
blood or blood products or animal blood or blood products suspected
of being contaminated with infectious agents known to be communicable
to humans.
(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
or vomitus, unless it contains fluid blood, as provided in
subdivision (d) of Section 117635.
(d) Waste which is not biohazardous, such as paper towels, paper
products, articles containing nonfluid blood, and other medical solid
waste products commonly found in the facilities of medical waste
generators.
(e) Hazardous waste, radioactive waste, or household waste.
(f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a farm or
ranch.
SEC. 6. Section 25024 of the Health and Safety Code is amended and
renumbered to read:
117705. "Medical waste generator" means any person whose act or
process produces medical waste and includes, but is not limited to, a
provider of health care, as defined in subdivision (d) of Section
56.05 of the Civil Code. All of the following are examples of
businesses that generate medical waste:
(a) Medical and dental offices, clinics, hospitals, surgery
centers, laboratories, research laboratories, unlicensed health
facilities, those facilities required to be licensed pursuant to
Division 2 (commencing with Section 1200), chronic dialysis clinics,
as regulated pursuant to Division 2 (commencing with Section 1200),
and education and research facilities.
(b) Veterinary offices, veterinary clinics, and veterinary
hospitals.
(c) Pet shops.
SEC. 7. Section 25025.9 of the Health and Safety Code is amended
and renumbered to read:
117742. "Parent organization" means an organization that employs
or contracts with health care professionals who provide health care
services at a location other than at a health care facility specified
in subdivision (a) of Section 117705.
SEC. 8. Section 25027 of the Health and Safety Code is amended and
renumbered to read:
117765. "Storage" means the holding of medical wastes, in
accordance with Chapter 9 (commencing with Section 118275), at a
designated accumulation area, offsite point of consolidation,
transfer station, other registered facility, or in a vehicle detached
from its means of locomotion.
SEC. 9. Section 25027.5 of the Health and Safety Code is amended
and renumbered to read:
117775. (a) "Transfer station" means any offsite location where
medical waste is loaded, unloaded, stored, or consolidated by a
registered hazardous waste hauler, or a holder of a limited quantity
hauling exemption granted pursuant to Section 118030, during the
normal course of transportation of the medical waste.
(b) "Transfer station" does not include any onsite facility,
including, but not limited to, common storage facilities, facilities
of medical waste generators employed for the purpose of
consolidation, or onsite treatment facilities.
SEC. 10. Section 25030.5 of the Health and Safety Code is amended
and renumbered to read:
117904. (a) In addition to the consolidation points authorized
pursuant to Section 118147, the enforcement agency may approve a
location as a point of consolidation for the collection of
home-generated sharps waste, which, after collection, shall be
transported and treated as medical waste.
(b) A consolidation location approved pursuant to this section
shall be known as a "home-generated sharps consolidation point."
(c) A home-generated sharps consolidation point is not subject to
the requirements of Chapter 9 (commencing with Section 118275), to
the permit or registration requirements of this part, or to any
permit or registration fees, with regard to the activity of
consolidating home-generated sharps waste pursuant to this section.
(d) A home-generated sharps consolidation point shall comply with
all of the following requirements:
(1) All sharps waste shall be placed in sharps containers.
(2) Sharps containers ready for disposal shall not be held for
more than seven days without the written approval of the enforcement
agency.
(e) An operator of a home-generated sharps consolidation point
approved pursuant to this section shall not be considered the
generator of that waste.
(f) The medical waste treatment facility which treats the sharps
waste subject to this section shall maintain the tracking documents
required by Sections 118040 and 118165 with regard to that sharps
waste.
SEC. 11. Section 25041 of the Health and Safety Code is amended
and renumbered to read:
117930. Small quantity generators that treat waste onsite,
pursuant to subdivision (a) of Section 117925, shall register with
the enforcement agency prior to the commencement of treatment.
SEC. 12. Section 25055 of the Health and Safety Code is amended
and renumbered to read:
117975. A medical waste generator required to register pursuant
to this chapter shall maintain individual treatment, and tracking
records, if medical waste is removed from the generator's site for
treatment, for three years or for the period specified in the
regulations.
SEC. 13. Section 25061 of the Health and Safety Code is amended
and renumbered to read:
118030. (a) A medical waste generator or parent organization that
employs health care professionals who generate medical waste may
apply to the enforcement agency for a limited-quantity hauling
exemption, if the generator or health care professional meets all of
the following requirements:
(1) The generator or health care professional generates less than
20 pounds of medical waste per week, transports less than 20 pounds
of medical waste at any one time, and the generator or parent
organization has on file one of the following:
(A) 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.
(B) 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.
(C) If the parent organization is a large quantity generator, a
medical waste management plan prepared pursuant to Section 117960.
(2) The generator or health care professional who generated the
medical waste transports the medical waste himself or herself, or
directs a member of his or her staff to transport the medical waste,
to a permitted medical waste treatment facility, a transfer station,
a parent organization, or another health care facility for the
purpose of consolidation before treatment and disposal.
(3) Except as provided in paragraph (4), the generator maintains a
tracking document, as specified in Section 118040.
(4) (A) Notwithstanding paragraph (3), if a health care
professional who generates medical waste returns the medical waste to
the parent organization, 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:
(i) The name of the person transporting the medical waste.
(ii) The number of containers and type of medical waste. This
subparagraph 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 medical waste in any container.
(iii) The date that the medical waste was returned.
(B) This paragraph does not prohibit the use of a single document
to verify the return of more than one container over a period of
time, if the form or log is maintained in the files of the parent
organization once the page is completed.
(b) The limited-quantity hauling exemption authorized by this
section is valid for a period of one year.
(c) An application for an initial or a renewal of a
limited-quantity hauling exemption shall be accompanied by a fee of
twenty-five dollars ($25). The application shall identify each
person who will transport medical waste for the transporter. If the
generator or parent organization identifies more than four persons
who will be transporting medical waste, the generator or parent
organization shall pay an additional fee of five dollars ($5) for
each person, up to a maximum additional fee of twenty-five dollars
($25).
SEC. 14. Section 25062.5 of the Health and Safety Code is amended
and renumbered to read:
118035. For the purpose of transferring medical waste prior to
reaching a permitted medical waste treatment facility, medical waste
shall not be unloaded, reloaded, or transferred to another vehicle at
any location, except at a permitted medical waste transfer station
or in the case of a vehicle breakdown or other emergency.
SEC. 15. Section 25063 of the Health and Safety Code is amended
and renumbered 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
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 and quantity 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.
(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. 16. Section 25070.4 of the Health and Safety Code is amended
and renumbered to read:
118147. Notwithstanding any other provision of this chapter, a
registered medical waste generator, which is a facility specified in
subdivisions (a) and (b) of Section 117705, may accept home-generated
sharps waste, to be consolidated with the facility's medical waste
stream, subject to all of the following conditions:
(a) The generator of the sharps waste, a member of the generator'
s family, or a person authorized by the enforcement agency transports
the sharps waste to the medical waste generator's facility.
(b) The sharps waste is accepted at a central location at the
medical waste generator's facility.
(c) A reference to, and a description of, the actions taken
pursuant to this section are included in the facility's medical waste
management plan adopted pursuant to Section 117960.
SEC. 17. Section 25080 of the Health and Safety Code is amended
and renumbered to read:
118275. To containerize or store medical waste, a person shall do
all of the following:
(a) Medical waste shall be contained separately from other waste
at the point of origin in the producing facility. Sharps containers
may be placed in biohazard bags or in containers with biohazard bags.
(b) Biohazardous waste, except biohazardous waste as defined in
subdivision (g) of Section 117635, shall be placed in a red biohazard
bag conspicuously labeled with the words "Biohazardous Waste" or
with the international biohazard symbol and the word "BIOHAZARD."
(c) Sharps waste shall be contained in a sharps container pursuant
to Section 118285.
(d) (1) Biohazardous waste, which meets the conditions of
subdivision (f) of Section 117635 because it is contaminated through
contact with, or having previously contained, chemotherapeutic
agents, shall be segregated for storage, and, when placed in a
secondary container, that container shall be labeled with the words
"Chemotherapy Waste", "CHEMO", or other label approved by the
department on the lid and on the sides, so as to be visible from any
lateral direction, to ensure treatment of the biohazardous waste
pursuant to Section 118222.
(2) Biohazardous waste, which meets the conditions of subdivision
(f) of Section 117635 because it is comprised of human surgery
specimens or tissues which have been fixed in formaldehyde or other
fixatives, shall be segregated for storage and, when placed in a
secondary container, that container shall be labeled with the words
"Pathology Waste", " PATH", or other label approved by the department
on the lid and on the sides, so as to be visible from any lateral
direction, to ensure treatment of the biohazardous waste pursuant to
Section 118222.
(e) Sharps waste, which meets the conditions of subdivision (f) of
Section 117635, shall be placed in sharps containers labeled in
accordance with the industry standard with the words "Chemotherapy
Waste", "Chemo", or other label approved by the department, and
segregated to ensure treatment of the sharps waste pursuant to
Section 118222.
(f) Biohazardous waste, which are recognizable human anatomical
parts, as specified in Section 118220, shall be segregated for
storage and, when placed in a secondary container for treatment as
pathology waste, that container shall be labeled with the words
"Pathology Waste", "PATH", or other label approved by the department
on the lid and on the sides, so as to be visible from any lateral
direction, to ensure treatment of the biohazardous waste pursuant to
Section 118222.
(g) Biohazardous waste, which meets the conditions specified in
subdivision (g) of Section 117635, shall be segregated for storage
and, when placed in a container or secondary container, that
container shall be labeled with the words "INCINERATION ONLY" or
other label approved by the department on the lid and on the sides,
so as to be visible from any lateral direction, to ensure treatment
of the biohazardous waste pursuant to Section 118222.
SEC. 18. Section 25081 of the Health and Safety Code is amended
and renumbered to read:
118280. To containerize biohazard bags, a person shall do all of
the following:
(a) The bags shall be tied to prevent leakage or expulsion of
contents during all future storage, handling, or transport.
(b) Biohazardous waste, except biohazardous waste as defined in
subdivision (g) of Section 117635, shall be bagged in accordance with
subdivision (b) of Section 118275 and placed for storage, handling,
or transport in a rigid container which may be disposable, reusable,
or recyclable. Containers shall be leak resistant, have
tight-fitting covers, and be kept clean and in good repair.
Containers may be recycled with the approval of the enforcement
agency. Containers may be of any color and shall be labeled with the
words "Biohazardous Waste" or with the international biohazard
symbol and the word "BIOHAZARD" on the lid and on the sides so as to
be visible from any lateral direction. Containers meeting the
requirements specified in Section 66840 of Title 22 of the California
Code of Regulations, as it read on December 31, 1990, may also be
used until the replacement of the containers is necessary or existing
stock has been depleted.
(c) Biohazardous waste shall not be removed from the biohazard bag
until treatment as prescribed in Chapter 8 (commencing with Section
118215) is completed, except to eliminate a safety hazard, or by the
enforcement officer in performance of an investigation pursuant to
Section 117820. Biohazardous waste shall not be disposed of before
being treated as prescribed in Chapter 8 (commencing with Section
118215).
(d) (1) Except as provided in paragraph (5), a person generating
biohazardous waste shall comply with the following requirements:
(A) If the person generates 20 or more pounds of biohazardous
waste per month, the person shall not contain or store biohazardous
or sharps waste above 0* Centigrade (32* Fahrenheit) at any onsite
location for more than seven days without obtaining prior written
approval of the enforcement agency.
(B) If a person generates less than 20 pounds of biohazardous
waste per month, the person shall not contain or store biohazardous
waste above 0* Centigrade (32* Fahrenheit) at any onsite location for
more than 30 days.
(2) A person may store biohazardous or sharps waste at or below 0*
Centigrade (32* Fahrenheit) at an onsite location for not more than
90 days without obtaining prior written approval of the enforcement
agency.
(3) A person may store biohazardous or sharps waste at a permitted
transfer station at or below 0* Centigrade (32* Fahrenheit) for not
more than 30 days without obtaining prior written approval of the
enforcement agency.
(4) A person shall not store biohazardous or sharps waste above 0*
Centigrade (32* Fahrenheit) at any location or facility which is
offsite from the generator for more than seven days before treatment.
(5) Notwithstanding paragraphs (1) to (4), inclusive, if the odor
from biohazardous or sharps waste stored at a facility poses a
nuisance, the enforcement agency may require more frequent removal.
(e) Waste that meets the definition of biohazardous waste in
subdivision (g) of Section 117635 shall not be subject to the
limitations on storage time prescribed in subdivision (d). A person
may store that biohazardous waste at an onsite location for not
longer than 90 days without obtaining prior written approval from the
enforcement agency or the department, except that persons generating
not more than 10 pounds of that biohazardous waste per calendar year
may store less than 10 pounds of the biohazardous waste at any
onsite location for not longer than one year without obtaining prior
written approval from the enforcement agency or the department. A
person may store that biohazardous waste at a permitted transfer
station for not longer than 30 days without obtaining prior written
approval from the enforcement agency or the department. A person
shall not store that biohazardous waste at any location or facility
that is offsite from the generator for more than 30 days before
treatment.
SEC. 19. Section 25088 of the Health and Safety Code is amended
and renumbered to read:
118320.
(a) Except as provided in subdivision (b), compactors or grinders
shall not be used to process medical waste until after the waste has
been treated pursuant to Chapter 8 (commencing with Section 118215)
and rendered solid waste.
(b) (1) Grinding or compacting may be used when it is an integral
part of an alternative treatment method approved by the department.
(2) A compactor may be used to compact medical waste if the type
of medical waste compactor proposed to be used is evaluated by the
department, and approved by the department prior to its use pursuant
to the following criteria:
(A) The compactor operates without the release of liquids or
pathogenic microorganisms from the medical waste during placement of
the medical waste into, or removal of the medical waste from, the
compactor units, and during the compaction process.
(B) The compacted medical waste will not release liquids or
pathogens during any subsequent handling and no residual waste will
be left in the compactor unit after the process is completed.
(C) Compactor operations and maintenance personnel will not be at
any substantial increased risk of exposure to pathogens.
(D) The compactor has been demonstrated not to have any adverse
effects on any treatment method. If only specific treatment methods
are compatible with the compaction process, the department shall
condition its approval of the compactor for use only in conjunction
with treatment methods, with regard to which no adverse effects have
been demonstrated.
(c) Medical waste in bags or other containers shall not be subject
to compaction by any compacting device and shall not be placed for
storage or transport in a portable or mobile trash compactor, except
as allowed pursuant to subdivision (b).
SEC. 20. Section 25090 of the Health and Safety Code is amended
and renumbered to read:
118215. 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:
(a) (1) 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.
(2) Treatment with an alternative technology approved pursuant to
subdivision (d), which, due to the extremely high temperatures of
treatment in excess of 1300 degrees Fahrenheit, has received express
approval from the department.
(b) (1) Discharge to a public sewage system if the medical waste
is liquid or semiliquid, and not either of the following:
(A) Liquid or semiliquid laboratory waste, as defined in
subdivision (a) of Section 117635.
(B) Microbiological specimens, including those specified in
subdivision (b) of Section 117635.
(2) Medical waste discharge shall be consistent with the waste
discharge requirements placed on the public sewer system by the
California regional water quality control board with jurisdiction.
(c) 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:
(1) 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.
(2) 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 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 three years or for the period
specified in the regulations.
(3) 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 the attainment of
adequate sterilization conditions.
(4) The biological indicator Bacillus 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.
(5) Records of the procedures specified in paragraphs (1), (2),
and (4) shall be maintained for a period of not less than three
years.
(d) (1) Other alternative medical waste treatment methods which
are both of the following:
(A) Approved by the department.
(B) Result in the destruction of pathogenic micro-organisms.
(2) 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.
SEC. 21. Section 25090.5 of the Health and Safety Code is amended
and renumbered to read:
118220. Recognizable human anatomical parts, with the exception
of teeth not deemed infectious by the attending physician and surgeon
or dentist, shall be disposed of by interment or in accordance with
subdivision (a) of Section 118215, unless otherwise hazardous.
SEC. 22. Section 25090.6 of the Health and Safety Code is amended
and renumbered to read:
118222. (a) Biohazardous waste that meets the conditions of
paragraph (1) of subdivision (f) of Section 117635 shall be treated
pursuant to subdivision (a) of Section 118215 prior to disposal.
(b) Biohazardous waste that meets the conditions specified in
subdivision (g) of Section 117635 shall be treated pursuant to
subdivision (a) or (d) of Section 118215 prior to disposal.
SEC. 23. Section 25117.5 of the Health and Safety Code is amended
to read:
25117.5. (a) Waste that is hazardous only because it is medical
waste, as defined in the Medical Waste Management Act (Part 14
(commencing with Section 117600) of Division 104) shall not be
governed by, subject to fees assessed by, or otherwise subject to,
the requirements of this chapter or regulations adopted pursuant to
this chapter.
(b) Biohazardous waste that meets the conditions specified in
subdivision (f) or (g) of Section 117635 is not subject to this
chapter.
SEC. 24. Section 117747 is added to the Health and Safety Code, to
read:
117747. (a) "Pharmaceutical" means a prescription or
over-the-counter human or veterinary drug, including, but not limited
to, a drug as defined in Section 109925 or the Federal Food, Drug,
and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).
(b) For purposes of this part, "pharmaceutical" does not include
any pharmaceutical that is regulated pursuant to either of the
following:
(1) The federal Resource Conservation and Recovery Act of 1976, as
amended (42 U.S.C.A. Sec. 6901 et seq.).
(2) The Radiation Control Law (Chapter 8 (commencing with Section
114960) of Part 9).
SEC. 25. Section 117924 is added to the Health and Safety Code, to
read:
117924. (a) When the department is the enforcement agency, the
department shall impose and cause the collection of an annual medical
waste generator fee in an amount not to exceed twenty-five dollars
($25) on small quantity generators of medical waste, except for those
small quantity generators that are required to register pursuant to
Section 117925 and those generators generating only biohazardous
waste as defined in subdivision (g) of Section 117635. Nothing in
this part shall prevent the department from contracting with entities
other than the department for these fee collection activities or
from entering into agreements with medical waste transporters or
providers of medical waste mail-back systems for the collection of
these fees, if the department determines that such a fee collection
arrangement would be cost-effective.
(b) If the department determines to enter into a contract with a
medical waste transporter or provider of medical waste mail-back
systems for the collection of the fees, the department shall do all
of the following:
(1) Establish that not more than 5 percent of the fees collected
may be recovered by the medical waste transporter or provider of
medical waste mail-back systems as administrative costs for the
collection of those fees.
(2) Establish that the administrative costs for the collection of
the fees shall be the same for all medical waste transporters and
providers of medical waste mail-back systems.
(3) Prohibit any medical waste transporter or provider of medical
waste mail-back systems from waiving the generator fee without the
written approval of the department and only if the medical waste
generator has made a written request for the waiver.
(4) Require the medical waste transporter or provider of medical
waste mail-back systems to report the fees collected pursuant to
subdivision (a) to the department.
(5) Prohibit the medical waste transporter or provider of medical
waste mail-back systems from assuming the role of the department as
an enforcement agent for purposes of collecting the medical waste
generator fees.
(6) Require medical waste transporters or providers of medical
waste mail-back systems to include the following language in at least
12-point type on their invoices to medical waste generators.
"Pursuant to Section 117924 of the California Health and Safety
Code, the State Department of Health Services has contracted with us
to collect your annual medical waste generator fee. The department
may offset our costs of collection and administration in an amount
that may not exceed 5 percent of the fee collected. We may not waive
the fee without written approval of the department, and only if you
have made a written request for the waiver."