Amended in Senate June 4, 2014

Amended in Senate May 21, 2014

Amended in Senate July 11, 2013

Amended in Assembly May 8, 2013

Amended in Assembly March 12, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 333

Introduced by Assembly Member Wieckowski

February 13, 2013

An act to amend Sections 117605, 117665, 117695, 117700 begin insert , end insert 117710, 117725, 117747, 117765, 117775, 117805, 117820, 117835, 117885, 117890, 117900, 117903, 117904, 117918, 117920, 117924,117935, 117938, 117940, 117943, 117945, 117950, 117960, 117970, 117990, 118000, 118025, 118027, 118029, 118032, 118045, 118135, 118150, 118155, 118160, 118205, 118215, 118220, 118222, 118240, 118245, 118275, 118280, 118286, 118307, 118321.1, 118321.5, 118335, and 118345 of, to add Sections 117636, 117647, 117663, 117664, 117946, 117967, and 117976 to, to repeal Sections 117620, 117635, 117748, 117755, 117777 begin insert , end insert 117895, 117915, 117933, 117955, 117980, 117985, 118005, 118030, and 118040 of, and to repeal and add Sections 117630, 117662, 117690, 117750, 117770, 117780, and 117975 of, the Health and Safety Code, relating to medical waste.

LEGISLATIVE COUNSEL’S DIGEST

AB 333, as amended, Wieckowski. Medical waste.

(1) Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring specified biohazard materials to be disposed of in biohazard bags and requiring specified treatment for medical waste. Transportation, storage, treatment, or disposal of medical waste in a manner not authorized by the act is a crime. Existing law defines specified terms for purposes of the Medical Waste Management Act, including “biohazard bag,” “medical waste management plan,” “health care professional,” “sharps container,” “shipping document,” and “treatment.” Under existing law, health care professionals who generate medical waste are generally required to have medical waste transported by a registered hazardous waste transporter. Under existing begin delete law , end delete begin insert law, end insert a health care professional is a person licensed under specified provisions, including dentists and physicians and surgeons.

This bill would specify that the United States Department of Transportation has responsibility for the transportation of medical waste on public roads and highways and that the United States Postal Service has responsibility for the transportation of medical waste through the mail. The bill would remove and recast provisions of the act that are inconsistent with that authority. The bill would also redefine the specified terms for purposes of the Medical Waste Management Act, including those above, add definitions of terms, including a chemotherapeutic agent, and expand the scope of a health care professional to include any person who generates medical waste in a health care setting or in the course of providing health care services. The bill would include all subsets of waste in the definition of treatment. The bill would also authorize the color coding of sharps containers to segregate the waste stream if designated in the medical waste management plan.

(2) Existing law authorizes a local agency to adopt a medical waste management program to, among other things, issue medical waste registrations and permits and inspect medical waste generators and treatment facilities, and requires the local agency, if it elects to do so, to notify the department. Under existing law, if the local agency chooses not to adopt a medical waste management program or if the department withdraws its designation, then the department is the enforcement agency.

Existing begin delete law, end delete begin insert law end insert requires the department to impose and cause to be collected an annual medical waste generator fee, as specified. Existing law authorizes the department to contract with a medical waste transporter or provider of medical waste mail-back systems for the collection of these fees and authorizes the collecting body to recover not more than 5% of the fees as administrative costs.

This bill would remove the ability of the department to use medical waste mail-back systems for the collection of these fees and would authorize medical waste transporters that collect these fees to recover up to 7.5% as administrative costs.

(3) Under the Medical Waste Management Act, medical waste generators, including large quantity generators and small quantity generators, are subject to various requirements relating to registration, record retention, and transportation of medical waste.

This bill would revise the registration procedures and the record requirements for large quantity and small quantity generators. The bill would require large and small quantity generators that operate treatment equipment to receive annual training to operate the equipment. The bill would exempt from regulation as a hazardous waste hauler a small quantity generator or large quantity generator that meets specified requirements, including retaining specified documentation and complying with certain federal requirements relating to a materials of trade exception.

The bill would make technical, conforming, and clarifying changes relating to these provisions.

Existing law prohibits a large quantity generator from generating medical waste unless the large quantity generator is registered with the enforcement agency.

This bill would authorize a large quantity medical waste generator who is registered with the enforcement agency to generate medical waste at a temporary event, including vaccination clinics, and would require the large quantity generator to notify the enforcement agency of its participation at such an event.

(4) Existing law requires that all medical waste be hauled by either a registered hazardous waste hauler or by a person with an approved limited-quantity exemption granted pursuant to specified provisions of law. Existing law also specifies treatment methods and processes that medical waste treatment facilities are required to use, including requiring heat sensitive tape to show that materials went through a heat process, and requires a medical waste treatment facility to be permitted by the department.

This bill would make specified changes to the provisions relating to medical waste haulers, including removing provisions that conflict with the United States Department of Transportation regulation of those entities and making changes to the information medical waste haulers are required to provide to the department annually. This bill would also make various changes to the provisions relating to medical waste treatment facilities, including specifying the decontamination methods for a closure plan, lowering the time period for which records are maintained from 3 to 2 years, and authorizing the use of electronic information for operating records and shipping documents.

(5) Existing law exempts from specified provisions of the Medical Waste Management Act a person who is authorized to collect solid waste and who unknowingly transports medical waste to a solid waste facility, incidental to the collection of solid waste.

This bill would exempt those persons from the entire act, with regard to that waste, and would require the solid waste transporter to contact the originating generator of the medical waste to respond to the facility to provide ultimate proper disposal of the medical waste.

(6) Existing law requires that animals that die of infectious diseases be treated as medical waste, as specified, if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans.

This bill would require the carcasses of animals that have died of infectious diseases or that have been euthanized because of suspected exposure to infectious disease to be treated with a treatment technology approved by the department if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans. By expanding the definition of a crime, this bill would create a state-mandated local program.

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.

Vote: 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 117605 of the Health and Safety Code
is amended to read:

117605.  

(a) The United States Department of Transportation
(USDOT) is responsible for the transportation of medical waste
on public roads and highways. The United States Postal Service
(USPS) is responsible for the transportation of medical waste
through the mail and approves medical waste mail-back systems.
The standards USDOT enforces are found in Title 49 of the Code
of Federal Regulations. The standards USPS enforces are found
in Domestic Mail Manual 601.10.17.5 (Mailability: Hazardous
Materials: Sharps and Other Mailable Regulated Medical Waste).
The USDOT and USPS regulations preempt state laws.

(b) The Medical Waste Management Act does not preempt any
local ordinance regulating infectious waste, as that term was
defined by Section 25117.5 as it read on December 31, 1990, if
the ordinance was in effect on January 1, 1990, and regulated both
large and small quantity generators. Any ordinance may be
amended in a manner that is consistent with this part.

SEC. 2.  

Section 117620 of the Health and Safety Code is
repealed.

SEC. 3.  

Section 117630 of the Health and Safety Code is
repealed.

SEC. 4.  

Section 117630 is added to the Health and Safety Code,
to read:

117630.  

“Biohazard bag” means a disposable film bag that is
impervious to moisture. The film bags that are used for transport
shall be marked and certified by the manufacturer as having passed
the tests prescribed for tear resistance in the American Society for
Testing Materials (ASTM) D1922, “Standard Test Method for
Propagation Tear Resistance of Plastic Film and Thin Sheeting by
Pendulum Method” and for impact resistance in ASTM D 1709,
“Standard Test Methods for Impact Resistance of Plastic Film by
the Free-Falling Dart Method,” as those documents are published
on January 1, 2014. The film bag shall meet an impact resistance
of 165 grams and a tearing resistance of 480 grams in both parallel
and perpendicular planes with respect to the length of the bag. The
color of the bag shall be red, except when other colors are used to
further segregate the waste stream, including for trace
chemotherapy wastes, laboratory wastes, and other subsets of the
waste stream. If additional colors are used other than the standard
red bag, the color assignments shall be designated in the facility’s
medical waste management plan.

SEC. 5.  

Section 117635 of the Health and Safety Code is
repealed.

SEC. 6.  

Section 117636 is added to the Health and Safety Code,
to read:

117636.  

“Chemotherapeutic agent” means an agent that kills
or prevents the reproduction of malignant cells. Chemotherapeutic
agent excludes anti-inflammatory and antibiotic medications used
to treat malignant cells in the practice of veterinary medicine.

SEC. 7.  

Section 117647 is added to the Health and Safety Code,
to read:

117647.  

“Empty tubing or container” means a condition
achieved when tubing, a container, or inner liner removed from a
container that previously contained liquid or solid material,
including, but not limited to, a chemotherapeutic agent, is
considered empty. The tubing, container, or inner liner removed
from the container shall be considered empty if it has been emptied
begin delete by the generator as much as possible, using methods commonly
employed to remove waste material from tubing, containers, or
liners, end delete so that the following conditions are met:

(a) If the material that the tubing, container, or inner liner held
is pourable, no material can be poured or drained from the tubing,
container, or inner liner when held in any orientation, including,
but not limited to, when tilted or inverted.

(b) If the material that the tubing, 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.

SEC. 8.  

Section 117662 of the Health and Safety Code is
repealed.

SEC. 9.  

Section 117662 is added to the Health and Safety Code,
to read:

117662.  

“Health care professional” means any person who
generates medical waste in a health care setting or in the course
of providing a health care service.

SEC. 10.  

Section 117663 is added to the Health and Safety
Code, to read:

117663.  

“Health care and veterinary services” means services
organized, delivered, and maintained for the diagnosis, care,
immunization, prevention, and treatment of human and animal
illness.

SEC. 11.  

Section 117664 is added to the Health and Safety
Code, to read:

117664.  

“Health care and veterinary settings” means a facility,
location, place, or building that is organized, maintained, and
operated, in whole or in part, fixed or mobile, for the diagnosis,
care, prevention, and treatment of human and animal illness.

SEC. 12.  

Section 117665 of the Health and Safety Code is
amended to read:

117665.  

“Highly communicable diseases” means diseases,
such as those caused by organisms classified by the federal Centers
for Disease Control and Prevention as risk group 3 organisms or
higher.

SEC. 13.  

Section 117690 of the Health and Safety Code is
repealed.

SEC. 14.  

Section 117690 is added to the Health and Safety
Code, to read:

117690.  

(a) “Medical waste” means any biohazardous,
pathology, pharmaceutical, trace or bulk chemotherapy waste not
regulated by the federal Resource Conservation and Recovery Act
of 1976 (Public Law 94-580), as amended; sharps and trace
chemotherapy wastes generated in a health care setting in the
diagnosis, treatment, immunization, or care of humans or animals;
waste generated in autopsy or necropsy; waste generated during
preparation of a body for final disposition such as cremation or
interment; waste generated in research pertaining to the production
or testing of microbiologicals; waste generated in research using
human or animal pathogens; sharps and laboratory waste that poses
a potential risk of infection to humans generated in the inoculation
of animals in commercial farming operations; waste generated
from the consolidation of home-generated sharps; and waste
generated in the cleanup of trauma scenes. Biohazardous,
pathology, pharmaceutical, sharps, and trace chemotherapy wastes
that are classified as medical wastes shall not be subject to any of
the hazardous waste requirements found in Chapter 6.5
(commencing with Section 25100) of Division 20.

(b) For purposes of this part the following definitions apply:

(1) “Biohazardous waste” includes all of the following:

(A) (i) Regulated medical waste, clinical waste, or biomedical
waste that is a waste or reusable material derived from the medical
treatment of a human or from an animal that is suspected by the
attending veterinarian of being infected with a pathogen that is
also infectious to humans, which includes diagnosis and
immunization; or from biomedical research, which includes the
production and testing of biological products.

(ii) Regulated medical waste or clinical waste or biomedical
waste suspected of containing a highly communicable disease.

(B) Laboratory waste such as human specimen cultures or
animal specimen cultures that are infected with pathogens that are
also infectious to humans; cultures and stocks of infectious agents
from research; 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 defined by the department; culture
dishes, devices used to transfer, inoculate, and mix cultures; and
wastes identified by Section 173.134 of Title 49 of the Code of
Federal Regulations as Category B “once wasted” for laboratory
wastes.

(C) Waste that, at the point of transport from the generator’s
site or at the point of disposal contains recognizable fluid human
blood, fluid human blood products, containers, or equipment
containing human blood that is fluid, or blood from animals begin delete known
to be infected with highly communicable diseases. end delete begin insert suspected by
the attending veterinarian of being contaminated with infectious
agents known to be contagious to humans. end insert

(D) 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 communicable to humans.

(2) Pathology waste includes both of the following:

(A) Human body parts, with the exception of teeth, removed at
surgery and surgery specimens or tissues removed at surgery or
autopsy that are suspected by the health care professional of being
contaminated with infectious agents known to be contagious to
humans or having been fixed in formaldehyde or another fixative.

(B) Animal parts, tissues, fluids, or carcasses suspected by the
attending veterinarian of being contaminated with infectious agents
known to be contagious to humans.

(3) “Pharmaceutical waste” means a pharmaceutical, as defined
in Section 117747, begin insert including fluid bulk chemotherapy waste, end insert that
is a waste, as defined in Section 25124. For purposes of this part,
“pharmaceutical waste” does not include a pharmaceutical that
meets either of the following criteria:

(A) The pharmaceutical is being sent out of the state to a reverse
distributor, as defined in Section 4040.5 of the Business and
Professions Code, that is licensed as a wholesaler of dangerous
drugs by the California State Board of Pharmacy pursuant to
Section 4161 of the Business and Professions Code.

(B) The pharmaceutical is being sent by a reverse distributor,
as defined in Section 4040.5 of the Business and Professions Code,
offsite for treatment and disposal in accordance with applicable
laws, or to a reverse distributor that 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
and as a permitted transfer station if the reverse distributor is
located within the state.

(4) “Sharps waste” means a device contaminated with
biohazardous waste that has acute rigid corners, edges, or
protuberances capable of cutting or piercing, including, but not
limited to, hypodermic needles, hypodermic needles with syringes,
blades, needles with attached tubing, acupuncture needles, root
canal files, broken glass items used in health care such as Pasteur
pipettes and blood vials contaminated with biohazardous waste,
and any item capable of cutting or piercing from trauma scene
waste.

(5) “Trace chemotherapeutic waste” means waste that 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 that are empty. A biohazardous waste that meets
the conditions of this paragraph is not subject to the hazardous
waste requirements of the Department of Toxic Substances Control.

(6) “Trauma scene waste” means waste that is a regulated waste,
as defined in Section 5193 of Title 8 of the California Code of
Regulations, and that has been removed, is to be removed, or is in
the process of being removed, from a trauma scene by a trauma
scene waste management practitioner.

SEC. 15.  

Section 117695 of the Health and Safety Code is
amended to read:

117695.  

Medical waste that has been treated in accordance
with the provisions of the Medical Waste Management Act,
Chapter 8 (commencing with Section 118215), and that is not
otherwise hazardous, shall thereafter be considered solid waste as
defined in Section 40191 of the Public Resources Code and not
medical waste.

SEC. 16.  

Section 117700 of the Health and Safety Code is
amended 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 or an agent capable of causing
an infection that is highly communicable begin insert , as defined in Section
117665 end insert .

(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 or a highly communicable disease.

(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
or vomitus, unless it contains visible fluid blood.

(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,
including, but not limited to, home-generated sharps waste, as
defined in Section 117671.

(f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a
begin delete noncommercial end delete farm or ranch unless otherwise specified in law.

SEC. 17.  

Section 117710 of the Health and Safety Code is
amended to read:

117710.  

“Medical waste management plan” means a document
that is completed by generators of medical waste that describes
how the medical waste generated at their facility shall be
segregated, handled, stored, packaged, treated, or shipped for
treatment, as applicable, pursuant to Section 117935 for small
quantity generators and Section 117960 for large quantity
generators, on forms prepared by the enforcement agency, if those
forms are provided by the enforcement agency.

SEC. 18.  

Section 117725 of the Health and Safety Code is
amended to read:

117725.  

“Medical waste treatment facility” means all land and
structures, and other appurtenances or improvements on the land
begin insert under the control of the treatment facility end insert , used for treating medical
waste offsite from a medical waste generator, including all
associated handling and storage of medical waste as permitted by
the department.

SEC. 19.  

Section 117747 of the Health and Safety Code is
amended 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 begin delete or end delete begin insert of end insert 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.). This waste
stream shall be handled as a hazardous waste under the authority
of the Department of Toxic Substances Control.

(2) The Radiation Control Law (Chapter 8 (commencing with
Section 114960) of Part 9).

SEC. 20.  

Section 117748 of the Health and Safety Code is
repealed.

SEC. 21.  

Section 117750 of the Health and Safety Code is
repealed.

SEC. 22.  

Section 117750 is added to the Health and Safety
Code, to read:

117750.  

(a) “Sharps container” means a rigid puncture-resistant
container used in patient care or research activities meeting the
standards of, and receiving approval from, the United States Food
and Drug Administration as a medical device used for the collection
of discarded medical needles, other sharps, or, except as specified
in subdivision (b), other waste.

(b) For purposes of subdivision (a), “other waste” does not
include any waste 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. Sec. 6901 et seq.).

(2) The Radiation Control Law (Chapter 8 (commencing with
Section 114960) of Part 9).

(c) No specific color of the sharps container is required. If
multiple colored containers are used to segregate the waste stream,
including for trace chemotherapy waste, laboratory waste, and
other subsets of the waste stream, the color assignments for the
sharps containers shall be designated in the generator’s medical
waste management plan.

(d) Sharps containers, including those used to containerize trace
chemotherapeutic wastes, begin delete are not required to end delete begin insert shall not end insert be lined
with a plastic bag or inner liner.

SEC. 23.  

Section 117755 of the Health and Safety Code is
repealed.

SEC. 24.  

Section 117765 of the Health and Safety Code is
amended to read:

117765.  

“Storage” means the holding of medical wastes, in
compliance with the Medical Waste Management Act, including
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. 25.  

Section 117770 of the Health and Safety Code is
repealed.

SEC. 26.  

Section 117770 is added to the Health and Safety
Code, to read:

117770.  

“Shipping document” means the medical waste
shipping document required by the United States Department of
Transportation pursuant to Section 172.200 et seq. of Title 49 of
the Code of Federal Regulations or the document required by the
United States Postal Service pursuant to Domestic Mail Manual
601.10.17.5 (Mailability: Hazardous Materials: Sharps and Other
Mailable Regulated Medical Waste).

SEC. 27.  

Section 117775 of the Health and Safety Code is
amended to read:

117775.  

(a) “Transfer station” means an offsite location
permitted by the department where medical waste is loaded,
unloaded, stored, or consolidated by a registered hazardous waste
hauler 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. 28.  

Section 117777 of the Health and Safety Code is
repealed.

SEC. 29.  

Section 117780 of the Health and Safety Code is
repealed.

SEC. 30.  

Section 117780 is added to the Health and Safety
Code, to read:

117780.  

“Treatment” includes any of the following:

(a) Treatment for biohazardous waste is any method, technique,
or process designed to change the biological character or
composition of any biohazardous medical waste so as to eliminate
its potential for causing disease.

(b) Treatment of pathology waste is any method, technique, or
process to destroy the biological character or composition of any
pathology medical waste so as to eliminate its potential for creating
public or environmental health harm.

(c) Treatment for pharmaceutical waste is any method,
technique, or process designed to destroy the character or
composition of any pharmaceutical medical waste so as to eliminate
its potential for creating public or environmental health harm.

(d) Treatment for sharps waste is any method, technique, or
process designed to change the biological character or composition
of any biohazardous material found on the sharp so as to eliminate
its potential for causing disease.

(e) Treatment for trace chemotherapeutic waste is any method,
technique, or process designed to destroy the character or
composition of any trace chemotherapeutic medical waste so as
to eliminate its potential for creating public or environmental health
harm.

(f) Treatment for trauma scene waste is any method, technique,
or process designed to change the biological character or
composition of trauma scene medical waste so as to eliminate its
potential for causing disease.

SEC. 31.  

Section 117805 of the Health and Safety Code is
amended to read:

117805.  

A local agency that elects to implement a medical
waste management program shall notify the department of its intent
to do so.

SEC. 32.  

Section 117820 of the Health and Safety Code is
amended to read:

117820.  

A medical waste management program shall include,
but not be limited to, all of the following:

(a) Issuing medical waste registrations and permits pursuant to
the Medical Waste Management Act.

(b) Processing and reviewing the medical waste management
plans and inspecting onsite treatment facilities in accordance with
Chapter 4 (commencing with Section 117925) for all small quantity
medical waste generators required to be registered.

(c) Conducting an evaluation, inspection, or records review for
all facilities or persons issued a large quantity medical waste
registration pursuant to Chapter 5 (commencing with Section
117950) or issued a permit for an offsite or onsite medical waste
treatment facility pursuant to Chapter 7 (commencing with Section
118130).

(d) Inspecting medical waste generators in response to
complaints or emergency incidents, or as part of an investigation
or evaluation of the implementation of the medical waste
management plan.

(e) Inspecting medical waste treatment facilities in response to
a complaint or as part of an investigation or emergency incident.

(f) Taking enforcement action for the suspension or revocation
of medical waste permits issued by the local agency pursuant to
this part.

(g) Referring or initiating proceedings for civil or criminal
prosecution of violations specified in Chapter 10 (commencing
with Section 118335).

(h) Reporting in a manner determined by the department so that
the statewide effectiveness of the program can be determined.

SEC. 33.  

Section 117835 of the Health and Safety Code is
amended to read:

117835.  

The department shall establish and maintain a database
of persons registered as small quantity generators and as large
quantity generators for whom the department is the enforcement
agency.

SEC. 34.  

Section 117885 of the Health and Safety Code is
amended to read:

117885.  

(a) There is in the State Treasury the Medical Waste
Management Fund, that shall be administered by the director.
Money deposited in the fund shall be available to the department,
upon appropriation by the Legislature, for the purposes of this part.

(b) In addition to any other funds transferred by the Legislature
to the Medical Waste Management Fund, the following shall be
deposited in the fund:

(1) Fees, penalties, interest earned, and fines collected by, or
on behalf of, the department pursuant to this part.

(2) Funds granted by the federal government for purposes of
carrying out this part.

SEC. 35.  

Section 117890 of the Health and Safety Code is
amended to read:

117890.  

(a) No large quantity generator shall generate medical
waste unless the large quantity generator is registered with the
enforcement agency pursuant to this part.

(b) Registration pursuant to this part shall also allow the large
quantity generator to generate medical waste at temporary events,
including, but not limited to, health fairs, vaccination clinics, and
veteran stand downs, without further registration or permitting
required. The large quantity generator shall notify the local
enforcement agency of their intended participation in a temporary
event.

SEC. 36.  

Section 117895 of the Health and Safety Code is
repealed.

SEC. 37.  

Section 117900 of the Health and Safety Code is
amended to read:

117900.  

No person shall haul medical waste unless the person
is one of the following:

(a) A registered hazardous waste hauler pursuant to the
requirements of the Department of Toxic Substances Control.

(b) A mail-back system approved by the United States Postal
Service.

(c) A common carrier allowed to haul pharmaceutical waste
pursuant to Section 118029 or 118032.

(d) A small quantity generator or a large quantity generator that
has an exemption granted pursuant to either Section 117946 or
Section 117976, respectively.

SEC. 38.  

Section 117903 of the Health and Safety Code is
amended to read:

117903.  

No person shall treat medical waste unless the person
is permitted by the enforcement agency as required by this part or
unless the treatment is performed by a medical waste generator
and is a treatment method approved pursuant to Chapter 8
(commencing with Section 118215).

SEC. 39.  

Section 117904 of the Health and Safety Code is
amended 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, but shall be listed on the shipping document
in compliance with United States Department of Transportation
and United States Postal Service requirements.

(f) The medical waste treatment facility which treats the sharps
waste subject to this section shall maintain the shipping documents
required by Section 118165 with regard to that sharps waste.

SEC. 40.  

Section 117915 of the Health and Safety Code is
repealed.

SEC. 41.  

Section 117918 of the Health and Safety Code is
amended to read:

117918.  

Medical waste shall be treated using treatment
technologies approved by the department in accordance with
Chapter 8 (commencing with Section 118215).

SEC. 42.  

Section 117920 of the Health and Safety Code is
amended to read:

117920.  

The fee schedule specified in Section 117923 shall be
for the issuance of medical waste registrations and for conducting
inspections pursuant to this chapter when the department serves
as the enforcement agency for small quantity generators. This fee
schedule shall be adjusted annually in accordance with Section
100425 to reflect the actual costs of implementing this chapter.
Local enforcement agencies shall set fees that shall be sufficient
to cover their costs in implementing this part with regard to small
quantity generators required to be registered pursuant to Section
117925.

SEC. 43.  

Section 117924 of the Health and Safety Code is
amended 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
pharmaceutical waste as defined in begin insert paragraph (3) of end insert subdivision
begin delete (c) end delete begin insert (b) end insert of Section 117690. 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 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 for the collection of the fees, the
department shall do all of the following:

(1) Establish that not more than 7.5 percent of the fees collected
may be recovered by the medical waste transporter 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.

(3) Prohibit any medical waste transporter 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 to report the fees
collected pursuant to subdivision (a) to the department.

(5) Prohibit the medical waste transporter 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 to include the following
language in at least 12-point type on their invoices to medical
waste begin delete generators. end delete begin insert generators: end insert

“Pursuant to Section 117924 of the California Health and Safety
Code, the State Department of Public Health 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 7.5 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.”

(7) Ensure that generators subject to this section are required
to pay the fee only once per year.

SEC. 44.  

Section 117933 of the Health and Safety Code is
repealed.

SEC. 45.  

Section 117935 of the Health and Safety Code is
amended to read:

117935.  

Any small quantity generator required to register with
the enforcement agency pursuant to Section 117930 shall file with
the enforcement agency a medical waste management plan,
containing, but not limited to, all of the following that apply:

(a) The name of the person.

(b) The business address of the person.

(c) The type of business.

(d) The types, and the estimated average monthly quantity, of
medical waste generated.

(e) The type of treatment used onsite.

(f) The name and business address of the registered hazardous
waste hauler used by the generator for backup treatment and
disposal, for waste when the onsite treatment method is not
appropriate due to the hazardous or radioactive characteristics of
the waste.

(g) The name of the registered hazardous waste hauler used by
the generator to have untreated medical waste removed for
treatment and disposal.

(h) The name of the common carrier used by the generator to
transport pharmaceutical waste offsite for treatment and disposal
pursuant to Section 118032.

(i) The steps taken to categorize the pharmaceutical wastes
generated at the facility to ensure that the wastes are properly
disposed of as follows:

(1) Pharmaceutical wastes classified by the federal Drug
Enforcement Agency (DEA) as “controlled substances” are
disposed of in compliance with DEA requirements.

(2) The name and business address of the hazardous waste hauler
used by the generator to have wastes that are not regulated pursuant
to the federal Resource Conservation and Recovery Act of 1976
and nonradioactive pharmaceutical wastes regulated as medical
waste safely removed for treatment in compliance with subdivision
(b) of Section 118222 as waste requiring specific methods.

(j) A closure plan for the termination of treatment at the facility.

(k) A statement certifying that the information provided is
complete and accurate.

SEC. 46.  

Section 117938 of the Health and Safety Code is
amended to read:

117938.  

(a) Small quantity generators using onsite steam
sterilization, incineration, or microwave technology to treat medical
waste are subject to biennial inspection of that onsite treatment
facility by the enforcement agency and may be subject to the
permitting requirements for onsite medical waste treatment
facilities as determined by the enforcement agency.

(b) The permitting requirements of subdivision (a) do not apply
when onsite steam sterilization is begin delete not end delete used for the treatment or
disposal of medical waste.

(c) The operators of the treatment equipment specified in
subdivision (a) shall be required to receive training in the operation
of the treatment equipment, proper protective equipment to wear,
if any, how to clean up spills, and other information required to
operate the treatment equipment in a safe and effective manner.
Annual refresher training for the operators shall be provided after
the initial training has been completed. The training shall be
documented for each treatment operator and retained on file at the
generator facility for a minimum of two years.

SEC. 47.  

Section 117940 of the Health and Safety Code is
amended to read:

117940.  

(a) Each enforcement agency shall follow procedures
consistent with this chapter in registering medical waste generators.

(b) Each medical waste generator registration for small quantity
generators issued by the enforcement agency shall be valid for two
years.

(c) An application for renewal of the registration for small
quantity generators shall be filed with the enforcement agency on
or before the expiration date.

(d) Generators shall submit within 30 days an updated
application form when any of the information specified in their
medical waste management plan changes.

SEC. 48.  

Section 117943 of the Health and Safety Code is
amended to read:

117943.  

A medical waste generator required to register pursuant
to this chapter shall maintain for a minimum of two years
individual treatment operating records, and if applicable, shipping
documents for all untreated medical waste shipped offsite for
treatment, and shall report or submit to the enforcement agency,
upon request, all of the following:

(a) Treatment operating records. Operating records shall be
maintained in written or electronic form.

(b) An emergency action plan complying with regulations
adopted by the department.

(c) Shipping documents or electronically archived shipping
documents maintained by the facility or medical waste hauler of
all untreated medical waste shipped offsite for treatment.

(d) Documentation shall be made available to the enforcement
agency onsite as soon as feasible, but no more than two business
days following the request.

SEC. 49.  

Section 117945 of the Health and Safety Code is
amended to read:

117945.  

Small quantity generators who are not required to
register pursuant to this chapter shall maintain on file in their office
all of following:

(a) An information document stating how the generator contains,
stores, treats, and disposes of any medical waste generated through
any act or process of the generator.

(b) Records required by the United States Department of
Transportation or the United States Postal Service of any medical
waste shipped offsite for treatment and disposal. The small quantity
generator shall maintain, or have available electronically at the
facility or from the medical waste hauler or common carrier, these
records, for not less than two years.

(c) Documentation shall be made available to the enforcement
agency onsite as soon as feasible, but no more than two days
following the request.

SEC. 50.  

Section 117946 is added to the Health and Safety
Code, to read:

117946.  

(a) A small quantity medical waste generator or parent
organization that employs health care professionals who generate
medical waste may transport medical waste generated in limited
quantities to the central location of accumulation, provided that
all of the following are met:

(1) The principal business of the generator is not to transport
or treat regulated medical waste.

(2) The generator shall adhere to the conditions and requirements
set forth in the materials of trade exception, as specified in Section
173.6 of Title 49 of the Code of Federal Regulations.

(3) A person transporting medical waste pursuant to this section
shall provide a form or log to the receiving facility, and the
receiving facility shall maintain the form or log for a period of two
years, containing all of the following information:

(A) The name of the person transporting the medical waste.

(B) The number of containers of medical waste transported.

(C) The date the medical waste was transported.

(b) A generator transporting medical waste pursuant to this
section shall not be regulated as a hazardous waste hauler pursuant
to Section 117660.

SEC. 51.  

Section 117950 of the Health and Safety Code is
amended to read:

117950.  

(a) Each large quantity generator, except as specified
in subdivisions (b) and (c), shall register with the enforcement
agency prior to commencement of the generation of medical waste.

(b) Large quantity generators operating as a business in the same
building, or that are associated with a group practice in the same
building, may register as one generator.

(c) Large quantity generators as specified in subdivision (a),
operating in different buildings on the same or adjacent property,
or as approved by the enforcement agency, may register as one
generator.

(d) “Adjacent,” for purposes of subdivision (c), means real
property within 400 yards from the property boundary of the
primary registration site. All federal transportation requirements
specified in Section 173.6 of Part 49 of the Code of Federal
Regulations shall apply for purposes of transporting medical waste
from adjacent properties.

SEC. 52.  

Section 117955 of the Health and Safety Code is
repealed.

SEC. 53.  

Section 117960 of the Health and Safety Code is
amended to read:

117960.  

Any large quantity generator required to register with
the enforcement agency shall file with the enforcement agency a
medical waste management plan containing, but not limited to, all
of the following:

(a) The name of the person.

(b) The business address of the person.

(c) The type of business.

(d) The types, and the estimated average monthly quantity, of
medical waste generated.

(e) The type of treatment used onsite, if applicable. For
generators with onsite medical waste treatment facilities, the
treatment capacity of the onsite treatment facility.

(f) The name and business address of the registered hazardous
waste hauler used by the generator to have untreated medical waste
removed for treatment, if applicable, and, if applicable, the name
and business address of the common carrier transporting
pharmaceutical waste pursuant to Section 118032.

(g) The name and business address of the offsite medical waste
treatment facility to which the medical waste is being hauled, if
applicable.

(h) An emergency action plan complying with regulations
adopted by the department.

(i) If applicable, the steps taken to categorize the pharmaceutical
wastes generated at the facility to ensure that the wastes are
properly disposed of as follows:

(1) Pharmaceutical wastes classified by the federal Drug
Enforcement Agency (DEA) as “controlled substances” are
disposed of in compliance with DEA requirements.

(2) The name and business address of the hazardous waste hauler
used by the generator to have wastes that are not regulated pursuant
to the federal Resource Conservation and Recovery Act of 1976
and nonradioactive pharmaceutical wastes regulated as medical
wastes safely removed for treatment in compliance with subdivision
(b) of Section 118222, as waste requiring specific methods.

(j) A closure plan for the termination of treatment at the facility.

(k) A statement certifying that the information provided is
complete and accurate.

SEC. 54.  

Section 117967 is added to the Health and Safety
Code, to read:

117967.  

Large quantity generators that treat medical waste
onsite using steam sterilization, incineration, microwave
technology, or other department approved treatment technology
to treat medical waste shall train the operators of the equipment
in its use, proper protective equipment to wear, if necessary, and
how to clean up spills to ensure that the equipment is being
operated in a safe and effective manner. Annual refresher training
for the operators shall be provided after the initial training has
been completed. The training shall be documented and the
documentation shall be retained at the facility for a minimum of
two years.

SEC. 55.  

Section 117970 of the Health and Safety Code is
amended to read:

117970.  

(a) Each enforcement agency shall follow procedures
consistent with this chapter in registering medical waste generators.

(b) Each medical waste registration issued by the enforcement
agency for large quantity generators shall be valid for one year.

(c) An application for renewal of the registration shall be filed
with the enforcement agency not less than 90 days prior to the
expiration date. Failure to meet this requirement shall result in an
assessment of a late fee.

(d) Generators shall update their medical waste management
plan within 30 days when any of the information in their medical
waste management plan changes and shall have the plan on file
for review during an inspection or upon request.

SEC. 56.  

Section 117975 of the Health and Safety Code is
repealed.

SEC. 57.  

Section 117975 is added to the Health and Safety
Code, to read:

117975.  

(a) A large quantity medical waste generator required
to register pursuant to this chapter shall maintain for a minimum
of two years individual treatment records and shipping documents
for all untreated medical waste shipped offsite for treatment. The
generator shall report or submit to the enforcement agency, upon
request, all of the following:

(1) Treatment operating records. Operating records shall be
maintained in written or electronic form.

(2) An emergency action plan in accordance with regulations
adopted by the department.

(3) Shipping documents or electronically archived shipping
documents maintained by the facility or medical waste hauler of
all untreated medical wastes shipped offsite for treatment.

(b) Documentation shall be made available to the enforcement
agency onsite as soon as feasible, but no more than two business
days following the request.

SEC. 58.  

Section 117976 is added to the Health and Safety
Code, to read:

117976.  

(a) A large quantity medical waste generator or parent
organization that employs health care professionals who generate
medical waste may transport medical waste generated in limited
quantities to the central location of accumulation, provided that
all of the following are met:

(1) The principal business of the generator is not to transport
or treat regulated medical waste.

(2) The generator shall adhere to the conditions and requirements
set forth in the materials of trade exception, as specified in Section
173.6 of Title 49 of the Code of Federal Regulations.

(3) A person transporting medical waste pursuant to this section
shall provide a form or log to the receiving facility, and the
receiving facility shall maintain the form or log for a period of two
years, containing all of the following information:

(A) The name of the person transporting the medical waste.

(B) The number of containers of medical waste transported.

(C) The date the medical waste was transported.

(b) A generator transporting medical waste pursuant to this
section shall not be regulated as a hazardous waste hauler pursuant
to Section 117660.

SEC. 59.  

Section 117980 of the Health and Safety Code is
repealed.

SEC. 60.  

Section 117985 of the Health and Safety Code is
repealed.

SEC. 61.  

Section 117990 of the Health and Safety Code is
amended to read:

117990.  

The fee schedule specified in Section 117995 shall be
for the issuance of medical waste registrations and onsite medical
waste treatment facility permits when the department serves as the
enforcement agency for large quantity generators. This fee schedule
shall be adjusted annually in accordance with Section 100425.
Local enforcement agencies shall set fees that shall be sufficient
to cover their costs in implementing this part with regard to large
quantity generators.

SEC. 62.  

Section 118000 of the Health and Safety Code is
amended to read:

118000.  

(a) Medical waste shall only be transported to a
permitted medical waste treatment facility, or to a transfer station
or another registered generator for the purpose of consolidation
before treatment and disposal.

(b) Facilities for the transfer of medical waste shall be annually
inspected and issued permits in accordance with the regulations
adopted pursuant to this part.

(c) 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. 63.  

Section 118005 of the Health and Safety Code is
repealed.

SEC. 64.  

Section 118025 of the Health and Safety Code is
amended to read:

118025.  

All medical waste shall be hauled by a registered
hazardous waste hauler, the United States Postal Service, or by a
person with an exception granted pursuant to Section 117946 for
small quantity generators or pursuant to Section 117976 for large
quantity generators.

SEC. 65.  

Section 118027 of the Health and Safety Code is
amended to read:

118027.  

A person who is authorized to collect solid waste, as
defined in Section 40191 of the Public Resources Code, who
unknowingly transports medical waste to a solid waste facility, as
defined in Section 40194 of the Public Resources Code, incidental
to the collection of solid waste, is exempt from the provisions of
the Medical Waste Management Act with regard to that waste. If
a solid waste transporter discovers that he or she has hauled
untreated medical waste to a landfill or materials recovery facility,
he or she shall contact the originating generator of the medical
waste to respond to the landfill or recovery facility to provide
ultimate proper disposal of the medical waste. The solid waste
facility operator may, at its discretion and after contacting the
generator, make arrangements for the proper treatment and disposal
of the medical waste at a facility approved by the department. Title
to the waste remains with the generator. Reimbursement costs for
the proper management of discovered waste shall be the originating
generator’s responsibility.

SEC. 66.  

Section 118029 of the Health and Safety Code is
amended to read:

118029.  

(a) Haulers of medical waste in California, with the
exception of those using a materials of trade exception as specified
in Sections 117946 and 117976, and United States Department of
Transportation licensed common carriers hauling pharmaceutical
waste, shall meet all United States Department of Transportation
requirements for transporting medical waste and shall be hazardous
waste haulers in California. On or before July 1, of each year, a
registered hazardous waste hauler that transports medical waste
shall so notify the department, and provide, in a format that
conforms to the protocol requirements for submission of data to
the department, the following information:

(1) Business name, address, and telephone number.

(2) Name of owner, operator, and contact person.

(3) Hazardous waste transporter registration number.

(4) The number of vehicles and trailers transporting medical
waste within the state as of that date.

(5) Types and quantities of medical waste collected, in pounds.

(6) The names of the generators whose waste has been
transported by the hauler and the amounts of medical waste
transported, by waste type category.

(b)  Each registered hazardous waste hauler shall provide to the
department a list of all medical waste generators serviced by that
person during the previous 12 months. That list shall include the
business name, business address, mailing address, telephone
number, and other information as required by the department to
collect annual fees pursuant to Section 117924. The list shall be
provided to the department within 10 days of the close of the
earliest calendar quarter ending September 30, December 31,
March 31, or June 30, or as otherwise required by the department.

SEC. 67.  

Section 118030 of the Health and Safety Code is
repealed.

SEC. 68.  

Section 118032 of the Health and Safety Code is
amended to read:

118032.  

A pharmaceutical waste generator or parent
organization that employs health care professionals who generate
pharmaceutical waste is exempt from the requirements of
subdivision (a) of Section 118000 if all of the following
requirements are met:

(a) The generator or parent organization has on file one of the
following:

(1) If the generator or parent organization is a small quantity
generator required to register pursuant to Chapter 4 (commencing
with Section 117925), a medical waste management plan prepared
pursuant to Section 117935.

(2) If the generator or parent organization is a small quantity
generator not required to register pursuant to Chapter 4
(commencing with Section 117925), the information document
maintained pursuant to subdivision (a) of Section 117945.

(3) If the generator or parent organization is a large quantity
generator, a medical waste management plan prepared pursuant
to Section 117960.

(b) The generator or health care professional who generated the
pharmaceutical waste transports the pharmaceutical waste himself
or herself, or directs a member of his or her staff to transport the
pharmaceutical waste to a parent organization or another health
care facility for the purpose of consolidation before treatment and
disposal, or contracts with a common carrier to transport the
pharmaceutical waste to a permitted medical waste treatment
facility or transfer station.

(c) Except as provided in subdivision (d), all of the following
requirements are met:

(1) Prior to shipment of the pharmaceutical waste, the generator
notifies the intended destination facility that it is shipping
pharmaceutical waste to it and provides a copy of the shipping
document, as specified in Section 117770.

(2) The generator and the facility receiving the pharmaceutical
waste maintain the shipping document, as specified in Section
117770.

(3) The facility receiving the pharmaceutical waste notifies the
generator of the receipt of the pharmaceutical waste shipment and
any discrepancies between the items received and the shipping
document, as specified in Section 117770, evidencing diversion
of the pharmaceutical waste.

(4) The generator notifies the enforcement agency of any
discrepancies between the items received and the shipping
document, as specified in Section 117770, evidencing diversion
of the pharmaceutical waste.

(d) (1) Notwithstanding subdivision (c), if a health care
professional who generates pharmaceutical waste returns the
pharmaceutical waste to the parent organization for the purpose
of consolidation before treatment and disposal over a period of
time, 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:

(A) The name of the person transporting the pharmaceutical
waste.

(B) The number of containers of pharmaceutical waste. This
clause does not require any generator to maintain a separate
pharmaceutical waste container for every patient or to maintain
records as to the specified source of the pharmaceutical waste in
any container.

(C) The date that the pharmaceutical waste was returned.

(2) The form or log described in paragraph (1) shall be
maintained in the files of the health care professional who generates
the pharmaceutical waste and the parent organization or another
health care facility that receives the pharmaceutical waste.

(3) This subdivision does not prohibit the use of a single
document to verify the return of more than one container to a parent
organization or another health care facility, provided the form or
log meets the requirements specified in paragraphs (1) and (2).

SEC. 69.  

Section 118040 of the Health and Safety Code is
repealed.

SEC. 70.  

Section 118045 of the Health and Safety Code is
amended to read:

118045.  

(a) The department shall charge an application fee
for a permit for a transfer station equal to one hundred dollars
($100) for each hour which the department spends on processing
the application, but not more than ten thousand dollars ($10,000).

(b) In addition to the fee specified in subdivision (a), the annual
permit fee for a transfer station is two thousand dollars ($2,000).

SEC. 71.  

Section 118135 of the Health and Safety Code is
amended to read:

118135.  

Each person operating an offsite medical waste
treatment facility shall obtain a permit pursuant to this chapter
from the department prior to commencement of the treatment
facility’s operation.

SEC. 72.  

Section 118150 of the Health and Safety Code is
amended to read:

118150.  

Each enforcement agency shall follow procedures that
are consistent with the Medical Waste Management Act and the
regulations adopted pursuant to this chapter, when issuing medical
waste permits.

SEC. 73.  

Section 118155 of the Health and Safety Code is
amended to read:

118155.  

A person required to obtain an offsite medical waste
treatment facility permit pursuant to this part shall file with the
enforcement agency an application containing, but not limited to,
all of the following:

(a) The name of the applicant.

(b) The business address of the applicant.

(c) The type of treatment provided, the treatment capacity of
the facility, a characterization of the waste treated at this facility.

(d) A disclosure statement, as provided in Section 25112.5,
except for onsite medical waste treatment facilities.

(e) A plan for closure of the facility using one of the methods
of decontamination specified in begin insert subdivision (a) or (b) of end insert Section
118295, thereby begin delete restoring end delete begin insert rendering end insert the property to an acceptable
sanitary condition following the ending of treatment services at
the site.

(f) Any other information required by the enforcement agency
for the administration or enforcement of this part or the regulations
adopted pursuant to this part.

SEC. 74.  

Section 118160 of the Health and Safety Code is
amended to read:

118160.  

(a) Prior to issuing or renewing a permit for an offsite
medical waste treatment facility, the department shall review the
compliance history of the applicant, under any local, state, or
federal law or regulation governing the control of medical waste
or pollution.

(b) The department shall, pursuant to this section, deny a permit,
or specify additional permit conditions, to ensure compliance with
applicable regulations, if the department determines that in the
three-year period preceding the date of application the applicant
has violated laws or regulations identified in subdivision (a) at a
facility owned or operated by the applicant, and the violations
demonstrate a recurring pattern of noncompliance or pose, or have
posed, a significant risk to public health and safety or to the
environment.

(c) In making the determination of whether to deny a permit or
to specify additional permit conditions, the department shall take
both of the following into consideration:

(1) Whether a permit denial or permit condition is appropriate
or necessary given the severity of the violation.

(2) Whether the violation has been corrected in a timely fashion.

SEC. 75.  

Section 118205 of the Health and Safety Code is
amended to read:

118205.  

The fee schedule specified in Section 118210 shall
cover the issuance of medical waste treatment facility permits and
an inspection program, when the department serves as the
enforcement agency. This fee schedule shall be adjusted annually
in accordance with Section 100425. The department may adjust
by regulation the fees specified in Section 118210 to reflect the
actual costs of implementing this chapter. Local enforcement
agencies shall set fees that shall be sufficient to cover their costs
in implementing this part with regard to large quantity generators.

SEC. 76.  

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.

(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 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. 77.  

Section 118220 of the Health and Safety Code is
amended to read:

118220.  

begin delete Recognizable human anatomical parts, end delete begin insert Pathology
waste, end insert with the exception of teeth, shall be disposed of by
interment, incineration, or alternative treatment technologies
approved to treat this type of waste.

SEC. 78.  

Section 118222 of the Health and Safety Code is
amended to read:

118222.  

(a) Pathology waste that meets the conditions of
begin insert paragraph (2) of end insert subdivision (b) of Section 117690 and trace
chemotherapy waste that meets the conditions of begin insert paragraph (5)
of end insert subdivision begin delete (e) end delete begin insert (b) end insert of Section 117690 shall be treated by
incineration or alternative treatment technologies approved to treat
that waste pursuant to paragraph (1) or paragraph (3) of subdivision
(a) of Section 118215 prior to disposal.

(b) Pharmaceutical waste from health care settings that meets
the conditions specified in begin insert paragraph (3) of end insert subdivision begin delete (c) end delete begin insert (b) end insert of
Section 117690 shall be treated by incineration or alternative
treatment technologies approved to treat that waste pursuant to
paragraph (1) or paragraph (3) of subdivision (a) of Section 118215
prior to disposal.

SEC. 79.  

Section 118240 of the Health and Safety Code is
amended to read:

118240.  

Notwithstanding Section 9141 of the Food and
Agricultural Code, animals that die from infectious diseases or
that are euthanized because they are suspected of having been
exposed to infectious disease shall be treated with a treatment
technology approved by the department for that use if, in the
opinion of the attending veterinarian or local health officer, the
carcass presents a danger of infection to humans.

SEC. 80.  

Section 118245 of the Health and Safety Code is
amended to read:

118245.  

The department shall charge an application fee for
evaluation of an alternative treatment technology of two thousand
five hundred dollars ($2,500) and shall charge an additional fee
equal to one hundred dollars ($100) per hour for each hour which
the department spends on processing the application, but not more
than a total of five thousand dollars ($5,000).

SEC. 81.  

Section 118275 of the Health and Safety Code is
amended to read:

118275.  

(a) To containerize or store medical waste, at the
point of generation and while collected in that room, a person shall
do all of the following:

(1) Medical waste, as defined in Section 117690, 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.

(2) Biohazardous waste, as defined in begin insert paragraph (1) of end insert
subdivision begin delete (a) end delete begin insert (b) end insert of Section 117690, 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.”

(3) Sharps waste, as defined in begin insert paragraph (4) of end insert subdivision
begin delete (d) end delete begin insert (b) end insert of Section 117690, including sharps and pharmaceutical
waste containerized pursuant to begin delete subdivision (g), end delete begin insert paragraph (7), end insert
shall be contained in a United States Food and Drug Administration
(USFDA) approved sharps container that meets USFDA labeling
requirements and is handled pursuant to Section 118285.

(4) Trace chemotherapy waste, as defined in begin insert paragraph (5) of end insert
subdivision begin delete (e) end delete begin insert (b) end insert of Section 117690, 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 sides,
so as to be visible from any lateral direction, to ensure treatment
of the biohazardous waste pursuant to Section 118222. Sharps
waste that is contaminated through contact with, or having
previously contained, chemotherapeutic agents, 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 shall be segregated to ensure
treatment of the sharps waste pursuant to Section 118222.

(5)  Pathology waste, as defined in begin insert paragraph (2) of end insert subdivision
(b) of Section 117690, 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 sides, so as to be visible from
any lateral direction, to ensure treatment of the waste pursuant to
Section 118222.

(6) Pharmaceutical waste, as defined in begin insert paragraph (3) of end insert
subdivision begin delete (c) end delete begin insert (b) end insert of Section 117690, shall be segregated for
storage in accordance with the facility’s medical waste management
plan to ensure that it is properly containerized for disposal in
compliance with United States Department of Transportation and
United States Drug Enforcement Agency (DEA) requirements.

(A) Pharmaceutical wastes classified by the DEA as “controlled
substances” shall be disposed of in compliance with DEA
requirements.

(B) Nonradioactive pharmaceutical wastes that are not subject
to the federal Resource Conservation and Recovery Act of 1976
(Public Law 94-580), as amended, and that are regulated as medical
waste are placed in a container or secondary container labeled with
the words “INCINERATION ONLY,” “PHARMACEUTICAL”
or other label approved by the department on the sides, so as to be
visible from any lateral direction, to ensure treatment of the
biohazardous waste pursuant to Section 118222.

(7) A person may consolidate into a common container, which
may be reusable, sharps waste, as defined in begin insert paragraph (4) of end insert
subdivision begin delete (d) end delete begin insert (b) end insert of Section 117690, and pharmaceutical wastes,
as defined in begin insert paragraph (3) end insert subdivision begin delete (c) end delete begin insert (b) end insert of Section 117690,
provided that the consolidated waste is treated pursuant to
paragraph (1) of subdivision (a) of Section 118215 and the
container meets the requirements of Section 118285. The container
shall be labeled with the biohazardous waste symbol and the words
“HIGH HEAT ONLY,” “INCINERATION,” or other label
approved by the department on the sides, so as to be visible from
any lateral direction, to ensure treatment of the waste pursuant to
this subdivision.

(b) To containerize medical waste being held for shipment
offsite for treatment, the waste shall be begin delete additionally end delete labeled, as
outlined in subdivision (a), on the begin delete lid as well as the end delete sides of the
container.

(c) When medical waste is containerized pursuant to
subdivisions (a) and (b) there is no requirement to label the
containers with the date that the waste started to accumulate.

SEC. 82.  

Section 118280 of the Health and Safety Code is
amended 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 in
compliance with United States Department of Transportation
requirements.

(b)  begin insert (1) end insert begin insert   end insert Medical waste may be placed into a biohazard bag and
tied, as required in subdivision (a), in a patient room and shall be
immediately transported begin insert upon completion of the procedure end insert directly
from the point of generation and placed into a biohazard container
stored in a soiled utility room or other biohazardous waste storage
area without having first been placed into a secondary container
in the patient room.

begin insert

(2) Medical waste may be placed into a biohazard bag hung on
a hamper stand in a surgery suite and the bag removed from the
hamper stand after completion of the procedure, taken out of the
surgery suite, and placed into a biohazard container stored in a
soiled utility room or other biohazard waste storage area.

end insert

(c) Biohazardous waste, except as provided in subdivision (b),
shall be bagged in accordance with subdivision (b) of Section
118275 and placed for storage, handling, or transport in a rigid
container that 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 sides so as to be visible from any lateral
direction. Containers shall comply with United States Department
of Transportation requirements.

(d) 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).

(e) (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 that waste
above 0° Centigrade (32° Fahrenheit) at an 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 that waste
above 0° Centigrade (32° Fahrenheit) at an onsite location for more
than 30 days.

(2) A person may store biohazardous 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 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. A transfer station that does not have storage
capacity at or below 0° Centigrade (32° Fahrenheit) may only store
waste for a maximum of three days without obtaining prior written
approval of the enforcement agency.

(4) A person shall not store biohazardous waste above 0°
Centigrade (32° Fahrenheit) at a location or facility that 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.

(f) Waste that meets the definition of pharmaceutical waste in
begin insert paragraph (3) of end insert subdivision begin delete (c) end delete begin insert (b) end insert of Section 117690 shall not
be subject to the limitations on storage time prescribed in
subdivision (e). A person may store that pharmaceutical waste at
an onsite location for not longer than 90 days when the container
is ready for disposal, unless prior written approval from the
enforcement agency is obtained. The container shall be emptied
at least once per year, unless prior written approval from the
enforcement agency is obtained. A person may store that
pharmaceutical waste at a permitted transfer station for not longer
than 30 days without obtaining prior written approval from the
enforcement agency. A person shall not store pharmaceutical waste
at a location or facility that is offsite from the generator for more
than 30 days before treatment.

(g) The containment and storage time for wastes consolidated
in a common container pursuant to begin insert paragraph (7) of end insert subdivision
begin delete (h) end delete begin insert (a) end insert of Section 118275 shall not exceed the storage time for any
category of waste set forth in this section.

SEC. 83.  

Section 118286 of the Health and Safety Code is
amended to read:

118286.  

(a) A person shall not knowingly place
home-generated sharps waste in any of the following containers:

(1) Any container used for the collection of solid waste,
recyclable materials, or greenwaste.

(2) Any container used for the commercial collection of solid
waste or recyclable materials from business establishments.

(3) Any roll-off container used for the collection of solid waste,
construction, and demolition debris, greenwaste, or other recyclable
materials.

(b) Home-generated sharps waste shall be transported only in
a sharps container, or other containers approved by the enforcement
agency, and shall only be managed at any of the following:

(1) A household hazardous waste facility pursuant to Section
25218.13.

(2) A “home-generated sharps consolidation point” as defined
in subdivision (b) of Section 117904.

(3) A medical waste generator’s facility pursuant to Section
118147.

(4) A facility through the use of a medical waste mail-back
container approved by the United States Postal Service.

SEC. 84.  

Section 118307 of the Health and Safety Code is
amended to read:

118307.  

Medical waste that is stored in an area prior to transfer
to the designated accumulation area, as defined in Section 118310,
shall be stored in an area that is either locked or under direct
supervision or surveillance. Intermediate storage areas shall be
marked with the international biohazard symbol or the signage
described in Section 118310. These warning signs shall be readily
legible from a distance of five feet. This section does not apply to
the rooms in which medical waste is generated.

SEC. 85.  

Section 118321.1 of the Health and Safety Code is
amended to read:

118321.1.  

(a) A trauma scene waste management practitioner
shall register with the department on forms provided by the
department.

(b) The department shall register a trauma scene waste
management practitioner and issue a trauma scene waste hauling
permit to a trauma scene waste management practitioner who
submits a completed application form and the registration fee,
upon approval of the application by the department.

(c) A registered trauma scene waste management practitioner
is exempt from the registration requirements imposed pursuant to
Chapter 6 (commencing with Section 118025) or Article 6.5
(commencing with Section 25167.1) of Chapter 6.5 of Division
20 upon haulers of medical waste.

(d) Registered trauma scene waste management practitioners
shall pay an annual fee of two hundred dollars ($200) to the
department for deposit in the fund. The fee revenues deposited in
the fund pursuant to this subdivision may be expended by the
department, upon appropriation by the Legislature, for the
implementation of this chapter.

SEC. 86.  

Section 118321.5 of the Health and Safety Code is
amended to read:

118321.5.  

(a) Trauma scene waste shall be removed from the
trauma scene immediately upon completion of the removal phase
of a trauma scene waste removal operation.

(b) Trauma scene waste shall be transported to a permitted
medical waste transfer station or treatment facility pursuant to the
conditions and requirements set forth in the materials of trade
exception specified in Section 173.6 of Title 49 of the Code of
Federal Regulations, or may be stored in a dedicated freezer at the
business location of the trauma scene waste management
practitioner for a period of not more than 14 days, or as otherwise
approved by the department.

SEC. 87.  

Section 118335 of the Health and Safety Code is
amended to read:

118335.  

(a) In order to carry out the purpose of this part, any
authorized representative of the enforcement agency may do any
of the following:

(1) Enter and inspect a facility for which a medical waste permit
or registration has been issued, for which a medical waste permit
or registration application has been filed, or that is subject to
registration or permitting requirements pursuant to this part. Enter
and inspect a vehicle for which a hazardous waste hauler
registration has been issued, for which an application has been
filed for a hazardous waste hauler registration, or that is subject
to registration requirements pursuant to this part.

(2) Inspect and copy any records, reports, test results, or other
information related to the requirements of this part or the
regulations adopted pursuant to this part.

(b) The inspection shall be made with the consent of the owner
or possessor of the facilities or, if consent is refused, with a warrant
duly issued pursuant to Title 13 (commencing with Section
1822.50) of Part 3 of the Code of Civil Procedure. However, in
the event of an emergency affecting the public health or safety, an
inspection may be made without consent or the issuance of a
warrant.

(c) Any traffic officer, as defined in Section 625 of the Vehicle
Code, and any peace officer, as defined in Section 830.1 or 830.2
of the Penal Code, may enforce Chapter 6 (commencing with
Section 118000) and this chapter, and for purposes of enforcing
these chapters, traffic officers and these peace officers are
authorized representatives of the department.

SEC. 88.  

Section 118345 of the Health and Safety Code is
amended to read:

118345.  

(a) Any person who intentionally makes any false
statement or representation in any application, label, shipping
document, record, report, permit, registration, or other document
filed, maintained, or used for purposes of compliance with this
part that materially affects the health and safety of the public is
liable for a civil penalty of not more than ten thousand dollars
($10,000) for each separate violation or, for continuing violations,
for each day that the violation continues.

(b) Any person who fails to register or fails to obtain a medical
waste permit in violation of this part, or otherwise violates any
provision of this part, any order issued pursuant to Section 118330,
or any regulation adopted pursuant to this part, is liable for a civil
penalty of not more than ten thousand dollars ($10,000) for each
violation of a separate provision of this part or, for continuing
violations, for each day that the violation continues.

SEC. 89.  

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.