Bill Text: CA AB333 | 2013-2014 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Medical waste.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2014-09-25 - Chaptered by Secretary of State - Chapter 564, Statutes of 2014. [AB333 Detail]
Download: California-2013-AB333-Amended.html
Bill Title: Medical waste.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2014-09-25 - Chaptered by Secretary of State - Chapter 564, Statutes of 2014. [AB333 Detail]
Download: California-2013-AB333-Amended.html
BILL NUMBER: AB 333 AMENDED
BILL TEXT
AMENDED IN SENATE MAY 21, 2014
AMENDED IN SENATE JULY 11, 2013
AMENDED IN ASSEMBLY MAY 8, 2013
AMENDED IN ASSEMBLY MARCH 12, 2013
INTRODUCED BY Assembly Member Wieckowski
FEBRUARY 13, 2013
An act to amend Sections 117605, 117665, 117695,
117700 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, and 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
and , 117967, and 117976 to, to
repeal Sections 117620, 117635, 117748, 117755, 117777
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 law , 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 above-referenced 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 law, 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.
(2)
(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.
(3)
(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.
(4)
( 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. This part (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.
117620. The department and any local enforcement agency initially
electing to implement a medical waste management program pursuant to
this part shall initiate that program and begin enforcement of its
provisions on or before April 1, 1991, except for medical waste
programs operating under Section 117605.
SECTION 1. SEC. 3. Section 117630 of
the Health and Safety Code is repealed.
SEC. 2. 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.
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. 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 by the generator as much as
possible, using methods commonly employed to remove waste material
from tubing, containers, or liners, 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. 3. SEC. 8. Section 117662 of
the Health and Safety Code is repealed.
SEC. 4. 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 Biosafety Level
IV risk group 3 organisms , that, in
the opinion of the infection control staff, the department, local
health officer, attending physician and surgeon, or attending
veterinarian, merit special precautions to protect staff, patients,
and other persons from infection or higher .
"Highly communicable diseases" does not include diseases such as
the common cold, influenza, or other diseases not representing a
significant danger to nonimmunocompromised persons.
SEC. 13. Section 117690 of the Health
and Safety Code is repealed.
117690. (a) "Medical waste" means waste that meets both of the
following requirements:
(1) The waste is composed of waste that 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.
(E) Removal of a regulated waste, as defined in Section 5193 of
Title 8 of the California Code of Regulations, from a trauma scene by
a trauma scene waste management practitioner.
(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.
(c) Medical waste includes trauma scene waste.
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 clean up 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 known to
be infected with highly communicable diseases.
(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, 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. 5. 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 as defined in Section 117675
or an agent capable of causing an infection that is
highly communicable .
(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
, 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,
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
noncommercial farm or ranch unless otherwise specified in
law .
SEC. 6. 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. (a) "Medical waste
treatment facility" means all adjacent land and
structures, and other appurtenances or improvements on the land, used
for treating medical waste or for offsite
from a medical waste generator, including all associated
handling and storage of medical waste as permitted by
the department . Medical waste treatment facilities
are those facilities treating waste pursuant to subdivision (a) or
(c) of Section 118215. A medical waste treatment method approved
pursuant to subdivision (d) of Section 118215 may be designated as a
medical waste treatment facility by the department.
(b) "Adjacent," for purposes of subdivision (a), means real
property within 400 yards from the property boundary of the existing
medical waste treatment facility.
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 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.). 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.
117748. (a) "Pharmaceutical waste" means any pharmaceutical, as
defined in Section 117747, that is a waste, as defined in Section
25124.
(b) For purposes of this part, "pharmaceutical waste" does not
include any pharmaceutical that meets either of the following
criteria:
(1) The pharmaceutical is being sent out of the State of
California 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.
(2) 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 of California.
SEC. 7. SEC. 21. Section 117750 of
the Health and Safety Code is repealed.
SEC. 8. 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 federal
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, are not required to be lined with a plastic
bag or inner liner.
SEC. 23. Section 117755 of the Health
and Safety Code is repealed.
117755. "Sharps waste" means any device having acute rigid
corners, edges, or protuberances capable of cutting or piercing,
including, but not limited to, all of the following:
(a) Hypodermic needles, hypodermic needles with syringes, blades,
needles with attached tubing, syringes contaminated with
biohazardous waste, acupuncture needles, and root canal files.
(b) Broken glass
items, such as Pasteur pipettes and blood vials contaminated with
biohazardous waste.
(c) Any item capable of cutting or piercing that is contaminated
with trauma scene waste.
SEC. 9. 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. 10. SEC. 25. Section 117770 of
the Health and Safety Code is repealed.
SEC. 11. 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 federal 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 any
an offsite location permitted by the department
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. 28. Section 117777 of the Health
and Safety Code is repealed.
117777. "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. 12. SEC. 29. Section 117780 of
the Health and Safety Code is repealed.
SEC. 13. 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.
(b)
(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.
(c)
(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. Except as provided in subdivision (a) of Section
117810, a A local agency that elects to
implement a medical waste management program shall notify the
department within 90 days from the effective date of the act
enacting this part of its intent to do so
.
SEC. 32. Section 117820 of the Health
and Safety Code is am ended to read:
117820. A medical waste management program shall include, but not
be limited to, all of the following:
(a) Issuing medical waste registrations pursuant to
Chapter 5 (commencing with Section 117950) and permits
pursuant to Chapter 7 (commencing with Section 118130)
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 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
data base database of persons registered
under Chapter 4 (commencing with Section 117925) and persons
registered under Chapter 5 (commencing with Section 117950)
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.
(c) This section shall become operative on July 1, 1993.
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.
117895. A small quantity generator that treats medical waste
onsite by steam sterilization, incineration, or microwave technology
shall register with the enforcement agency pursuant to this part.
SEC. 37. Section 117900 of the Health
and Safety Code is amended to read:
117900. No person shall haul medical waste unless the person
meets either is one of the following
requirements :
(a) The person is registered pursuant to Article 6 (commencing
with Section 25160) and Article 6.5 (commencing with Section 25167.1)
of Chapter 6.5 of Division 20 and Chapter 30 (commencing with
Section 66001) of Division 4 of Title 22 of the California Code of
Regulations.
(b) The person has an approved limited-quantity exemption granted
pursuant to Section 118030.
(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. 14. 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 tracking
shipping documents required by Sections
118040 and Section 118165 with regard to that
sharps waste.
SEC. 40. Section 117915 of the Health
and Safety Code is repealed.
117915. Containment and storage of medical waste shall be in
accordance with Chapter 9 (commencing with Section 118275).
SEC. 15. 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. On or before January 1, 1993, the department may
adjust by regulation the fees specified in Section 117923
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
biohazardous pharmaceutical waste as defined in
subdivision (g) (c) of Section
117635 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 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 7.5
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 Public 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 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.
117933. Common storage facilities subject to Section 117928 shall
obtain a permit from the enforcement agency on or before April 1,
1991, where the storage of medical waste in the common storage
facility began prior to that date.
In those cases where the storage of medical waste begins after
April 1, 1991, permits shall be obtained pursuant to this chapter
prior to commencement of storage of medical waste in the common
storage facility.
SEC. 16. 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 inspection and permitting requirements
of subdivision (a) do not apply when onsite steam sterilization is
not 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 subdivisions
(a) to (i), inclusive, of Section 117935 their medical
waste management plan changes.
SEC. 17. 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. 18. 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 federal 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. 19. 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. 20. 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.
117955. Large quantity generators subject to Section 117950 shall
register with the enforcement agency on or before April 1, 1991, if
the generation of medical waste began prior to that date. In those
cases where the generation of medical waste begins after April 1,
1991, registration shall be completed pursuant to this chapter prior
to commencement of the generation of medical waste.
SEC. 21. 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. 22. 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. 23. SEC. 56. Section 117975 of
the Health and Safety Code is repealed.
SEC. 24. 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. 25. 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.
117980. Containment and storage of medical waste shall be in
accordance with Chapter 9 (commencing with Section 118275).
SEC. 60. Section 117985 of the Health
and Safety Code is repealed.
117985. Treatment of medical waste shall be in accordance with
Chapter 8 (commencing with Section 118215).
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.
On or before January 1, 1993, the department may adjust by
regulation the fees specified in Section 117995 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. 62. Section 118000 of the Health
and Safety Code is amended to read:
118000. (a) Except as otherwise exempted pursuant to Section
118030 or 118032, all medical waste transported to an offsite medical
waste treatment facility shall be transported in accordance with
this chapter by a registered hazardous waste transporter issued a
registration certificate pursuant to Chapter 6 (commencing with
Section 118025) and Article 6.5 (commencing with Section 25167.1) of
Chapter 6.5 of Division 20. A hazardous waste transporter
transporting medical waste shall have a copy of the transporter's
valid hazardous waste transporter registration certificate in the
transporter's possession while transporting medical waste. The
transporter shall show the certificate, upon demand, to any
enforcement agency personnel or authorized employee of the Department
of the California Highway Patrol.
(b) Except for small quantity generators transporting medical
waste pursuant to Section 118030 or small quantity generators or
common carriers transporting pharmaceutical waste pursuant to Section
118032, medical waste shall be transported to a permitted offsite
medical waste treatment facility or a permitted transfer station in
leak-resistant and fully enclosed rigid secondary containers that are
then loaded into an enclosed cargo body.
(c) A person shall not transport medical waste in the same vehicle
with other waste unless the medical waste is separately contained in
rigid containers or kept separate by barriers from other waste, or
unless all of the waste is to be handled as medical waste in
accordance with this part.
(d)
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 , pursuant to
this part .
(e)
(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.
(f) Any persons manually loading or unloading containers of
medical waste shall be provided by their employer at the beginning of
each shift with, and shall be required to wear, clean and protective
gloves and coveralls, changeable lab coats, or other protective
clothing. The department may require, by regulation, other protective
devices appropriate to the type of medical waste being handled.
(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.
118005. (a) Notwithstanding any other provision of this chapter,
trauma scene waste may be transported by a trauma scene management
practitioner registered pursuant to Section 118321.1.
(b) The exemption specified in Section 118030 for limited
quantity hauling shall not apply to the transportation of trauma
scene waste.
(c) (1) A business that has contracted with, or that currently
employs, a person whose services may include the cleanup of trauma
scene waste in the manner specified in Section 118321.6 may apply, on
forms provided by the department, to the department for an exemption
from the requirements of Section 118321.1. This exemption shall be
known as an incidental trauma scene waste hauling permit, and shall
authorize the person to transport, by herself or himself, trauma
scene waste that is collected in the manner specified in Section
118321.6 to a permitted medical waste transfer station or a permitted
medical waste offsite treatment facility, or to a health care
facility, previously designated by mutual agreement, for
consolidation with the facility's existing medical waste stream.
(2) An application for an incidental trauma scene waste hauling
permit shall be accompanied by a fee of twenty-five dollars ($25) and
the incidental trauma scene waste hauling permit shall be valid for
one cleanup event. The application shall identify any person who will
transport trauma scene waste for the business pursuant to paragraph
(1).
SEC. 26. 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. 27. 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
pro per 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
September 1, 1993, and each year thereafter on or before
July 1, of each year, a registered hazardous waste
transporter which 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) Vehicle manufacturer name, vehicle model year, vehicle
identification number, and the license plate number of each vehicle
transporting medical waste.
(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) For transporters that begin transporting medical waste after
September 1, 1993, notification to the department, and provision of
the information required by subdivision (a) shall be provided to the
department prior to transporting medical waste.
(c) On or before September 1, 1993, each
(b) Each registered hazardous
waste transporter, and each provider of medical waste mail
back systems, as defined in subdivision (b) of Section 118245,
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. When the transportation of
registered hazardous waste by a medical waste transporter or the
provision of a medical waste mail back system begins after September
1, 1993, the initial 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.
(d) Subsequent to providing the initial list pursuant to
subdivision(c), registered hazardous waste transporters and providers
of medical waste mail back systems shall submit to the department
any changes made to the most recent list every three months, within
10 days of the close of the calendar quarters ending September 30,
December 31, March 31, and June 30, or as otherwise required by the
department.
SEC. 67. Section 118030 of the Health
and Safety Code is repealed.
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. 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 117915) 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 117915) 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
tracking shipping document, as specified in
Section 118040 117770 .
(2) The generator and the facility receiving the pharmaceutical
waste maintain the tracking shipping
document, as specified in Section 118040
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 tracking
shipping document, as specified in Section
118040 117770 , evidencing diversion of
the pharmaceutical waste.
(4) The generator notifies the enforcement agency of any
discrepancies between the items received and the tracking
shipping document, as specified in Section
118040 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.
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 of medical waste transported and the quantity or
aggregate weight 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. 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) , or as
provided in the regulations adopted by the department .
(b) In addition to the fee specified in subdivision (a), the
annual permit fee for a transfer station issued a permit
pursuant to subdivision (e) of Section 118000 is two
thousand dollars ($2,000) , or as provided in the
regulations adopted pursuant to this part .
SEC. 71. Section 118135 of the Health
and Safety Code is amended to read:
118135. On or before April 1, 1991, each
Each person operating a an offsite
medical waste treatment facility shall obtain a permit pursuant
to this chapter from the department. If the medical waste
treatment facility begins operation after April 1, 1991, the permit
shall be obtained pursuant to this article 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. (a) Each
enforcement agency shall follow procedures that are consistent with
this chapter, the Medical Waste Management
Act and the regulations adopted pursuant to this chapter, when
issuing medical waste permits.
(b) Each person operating a medical waste treatment facility
pursuant to a hazardous waste facilities permit or grant of interim
status pursuant to Article 9 (commencing with Section 25200) of
Chapter 6.5 of Division 20, as of January 1, 1991, shall be
considered to have the medical waste permit required by this article
until January 1, 1992, unless the enforcement agency with
jurisdiction over its activities has taken final action prior to
January 1, 1992, on an application for a permit pursuant to this
article.
(c) Each medical waste facility subject to subdivision (b) shall
operate in accordance with the standards and procedures contained in
this chapter, and on and after January 1, 1991, is not subject to the
standards and procedures contained in Chapter 6.5 (commencing with
Section 25100) of Division 20.
SEC. 73. Section 118155 of the Health
and Safety Code is amended to read:
118155. Any A person required to
obtain a an offsite medical waste treatment
facility permit pursuant to this part shall file with the
enforcement agency an application , on forms prescribed by
the department, 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
, and the estimated average monthly quantity of waste
treated at the facility .
(d) A disclosure statement, as provided in Section 25112.5, except
for onsite medical waste treatment facilities.
(e) Evidence satisfactory to the enforcement agency that the
operator of the medical waste treatment facility has the ability to
comply with this part and the regulations adopted pursuant to this
part.
(e) A plan for closure of the facility using one of the methods of
decontamination specified in Section 118295, thereby restoring 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 pursuant to Section 118130
, 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 ,
including, but not limited to, the Clean Air Act (42 U.S.C. Sec. 7401
et seq.) .
(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 addition to any other information required to be submitted
for the permitting of a facility pursuant to Section 118130, an
applicant who has owned or operated a facility regulated by the
department shall provide a description of all violations described in
subdivision (a), that occurred at any facility permitted and owned
or operated by the applicant in the state in the three years prior to
the date of application.
(d)
(c) In making the determination of whether to deny a
permit or to specify additional permit conditions pursuant
to subdivision (b) , 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. On or before January 1, 1993, the
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 three 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 the
attainment of adequate sterilization conditions 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 Bacillus
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
three 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) A medical waste Fluid blood or fluid
blood products may be discharged to a public sewage system
without treatment if it is not a biohazardous waste of a
type described in either subdivision (a) or (b) of Section 117635, it
is liquid or semiliquid, and 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 of a type described in subdivision (a) of
Section 117635 , as defined in Section 117690,
may be treated by a chemical disinfection if the medical
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. 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 paragraph (1) or paragraph (3) of
subdivision (a) of Section 118215, unless otherwise hazardous
, 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) Biohazardous waste that meets the conditions
of subdivision (f) of Section 117635 Pathology waste
that meets the conditions of subdivision (b) of Section 117690 and
trace chemotherapy waste that meets the conditions of subdivision (e)
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) Biohazardous Pharmaceutical
waste from health care settings that meets the conditions
specified in subdivision (g) of Section 117635
subdivision (c) of Sect ion 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. 28. 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. (a) The department
shall charge an application fee for evaluation of an alternative
treatment technology pursuant to subdivision (d) of Section
118215 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) , or as provided in the regulations adopted by the
department .
(b) The department shall charge an application fee of one
thousand dollars, ($1,000) for evaluation and approval of the use of
a medical waste mail back system, which sends medical waste generated
in this state to an out-of-state facility for treatment and disposal
pursuant to subdivision (f) of Section 118040.
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:
(a)
(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.
(b)
(2) Biohazardous waste, except biohazardous
waste as defined in subdivision (g) of Section 117635
as defined in subdivision (a) 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."
(c)
(3) Sharps waste , as defined in subdivision (d)
of Section 117690, including sharps and pharmaceutical waste
containerized pursuant to subdivision (g), 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.
(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,
(4) Trace chemotherapy waste, as
defined in subdivision (e) of S ection 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
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. 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.
(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,
(5) Pathology waste, as defined in
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 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.
(6) Pharmaceutical waste, as defined in subdivision (c) 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.
(h)
(7) A person may consolidate into a common container,
which may be reusable, sharps waste, as defined in Section
117755 subdivision (d) of Section 117690 , and
pharmaceutical wastes, as defined in Section 117747
subdivision (c) 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 lid and on the sides, so as to be visible from any
lateral direction, to ensure treatment of the biohazardous
waste pursuant to this subdivision.
(b) To containerize medical waste being held for shipment offsite
for treatment, the waste shall be additionally labeled, as outlined
in subdivision (a), on the lid as well as the 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) 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 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.
(b)
(c) Biohazardous waste, except biohazardous
waste as defined in subdivision (g) of Section 117635
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 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.
Containers shall comply with United States Department
of Transportation requirements.
(c)
(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).
(d)
(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
biohazardous or sharps that waste above 0
Centigrade (32 Fahrenheit) at any 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
biohazardous that waste above 0 Centigrade (32
Fahrenheit) at any an 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. 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 or sharps
waste above 0 Centigrade (32 Fahrenheit) at any
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.
(e)
(f) Waste that meets the definition of
biohazardous pharmaceutical waste in subdivision
(g) of Section 117635 (c) of Section 117690
shall not be subject to the limitations on storage time
prescribed in subdivision (d) (e) . A
person may store that biohazardous
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 or the
department is obtained. The container shall be emptied at
least once a per year, unless prior
written approval from the enforcement agency or the
department is obtained. A person may store that
biohazardous pharmaceutical 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 pharmaceutical waste at
any a location or facility that is offsite from
the generator for more than 30 days before treatment.
(f)
(g) The containment and storage time for wastes
consolidated in a common container pursuant to subdivision (h) 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) On or after September 1, 2008, no
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) On or after September 1, 2008, home-generated
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 department pursuant to subdivision
(b) of Section 118245 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 biohazardous
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) Notwithstanding subdivision (a), a person who possessed a
local business license as of January 1, 1997, and performs trauma
scene waste management activities may continue to do so until April
1, 1998, subject to both of the following conditions:
(1) The department has been notified of the trauma scene waste
management activities.
(2) Registration as a trauma scene waste management practitioner
is completed on or before April 1, 1998.
(c)
(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.
(d)
(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.
(e)
(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
subdivision (d) of Section 118000 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 or a limited-quantity exemption granted
, for which an application has been filed for a hazardous
waste hauler registration or a limited-quantity exemption
, 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,
tracking 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. 29. 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.
