BILL NUMBER: AB 333 AMENDED
BILL TEXT
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 117695, 117710, 117765, 117903,
117918, 117935, 117943, 117945, 117950, 117960, 117970,
118025, 118027, and 118240 of, to add Sections 117946 and
117976 to, and to repeal and add Section
Sections 117630 , 117662, 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.
Existing law defines a biohazard bag as a disposable red bag that
has the strength to preclude ripping, tearing, or bursting under
normal conditions of usage and handling and that is constructed of
material of sufficient single thickness strength to pass the 165-gram
dropped dart impact resistance test, as specified, and certified by
the bag manufacturer.
This bill would change the definition of a biohazard bag to a film
bag certified by the manufacturer as having passed specified tests
for tear resistance and impact resistance. The bill would require a
biohazard bag to be red unless other colors are used to further
segregate the waste stream. If additional colors are used, the bill
would require the color assignments to be designated in the facility'
s medical waste management plan.
(2) Existing law defines a medical waste management plan as a
document that is completed by generators of medical waste, as
specified, on forms provided by the State Department of Public Health
or a local agency.
This bill would define a medical waste management plan as a
document that describes how the medical waste generated at a
generator's facility shall be segregated, handled, stored, packaged,
treated, or shipped for treatment, as applicable, and would only
require the plan to be on department forms if those forms are
provided by the department or local agency.
This bill would redefine the above-referenced terms for purposes
of the Medical Waste Management Act 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.
(2) 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 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.
(3) 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) 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 117630 of the Health and Safety Code is
repealed.
SEC. 2. 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. 3. Section 117662 of the Health
and Safety Code is repealed.
117662. "Health care professional" means any person licensed or
certified pursuant to Division 2 (commencing with Section 500) of the
Business and Professions Code; any person licensed pursuant to the
Osteopathic Initiative Act, as set forth in Chapter 8 (commencing
with Section 3600) of Division 2 of the Business and Professions
Code, or pursuant to the Chiropractic Initiative Act, as set forth in
Chapter 2 (commencing with Section 1000) of Division 2 of the
Business and Professions Code; and any person certified pursuant to
Division 2.5 (commencing with Section 1797).
SEC. 4. 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. 3. SEC. 5. 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. 4. SEC. 6. 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. 7. Section 117750 of the Health
and Safety Code is repealed.
117750. "Sharps container" means a rigid puncture-resistant
container that, when sealed, is leak resistant and cannot be reopened
without great difficulty.
SEC. 8. 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 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).
SEC. 5. SEC. 9. 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. Section 117770 of the Health
and Safety Code is repealed.
117770. "Tracking document" means the medical waste tracking
document specified in Section 118040.
SEC. 11. 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 Department of Transportation
pursuant to Section 172.200 et seq. of Title 49 of the Code of
Federal Regulations.
SEC. 12 . Section 117780 of the
Health and Safety Code is repealed.
117780. "Treatment" means any method, technique, or process
designed to change the biological character or composition of any
medical waste so as to eliminate its potential for causing disease,
as specified in Chapter 8 (commencing with Section 118215).
SEC. 13. 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 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) 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.
SEC. 14. 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 subdivision (d) of
Section 118215 Chapter 8 (commencing with Section
118215) .
SEC. 15. Section 117918 of the Health
and Safety Code is amended to read:
117918. Treatment of medical Medical
waste shall be treated using treatment
technologies approved by the department in accordance with
Chapter 8 (commencing with Section 118215).
SEC. 16. 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, on
forms prescribed by the enforcement agency 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,
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, and, if
applicable, the 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.
(g) A statement indicating that the generator is hauling the
medical waste generated in his or her business pursuant to Section
118030 and the name and any business address of the treatment and
disposal facilities to which the waste is being hauled, if
applicable.
(h) The name and business address of the registered hazardous
waste hauler service provided by the building management to which the
building tenants may subscribe or are required by the building
management to subscribe and the name and business address of the
treatment and disposal facilities used, if applicable.
(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.
(i)
(k) A statement certifying that the information
provided is complete and accurate.
SEC. 17. 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, and tracking records, if applicable,
for three years, or for the period specified in the regulations,
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, both 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. 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 Department of
Transportation of any medical waste transported
shipped offsite for treatment and
disposal, including the quantity of waste transported, the date
transported, the name of the registered hazardous waste hauler or
individual hauling the waste pursuant to Section 118030, and, if
applicable, the name of the common carrier transporting
pharmaceutical waste pursuant to Section 118032. The small quantity
generator shall maintain these records for not less than two years
disposal . The small quantity generator sh
all 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. 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. 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. Large quantity generators owning or operating a
medical waste treatment facility shall also apply for a permit for
that treatment facility pursuant to Chapter 7 (commencing with
Section 118130) 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. 21. Section 117960 of the Health
and Safety Code is amended to read:
117960. Any large quantity generator required to register with
the enforcement agency pursuant to Section 117950
shall file with the enforcement agency a medical waste management
plan, on forms prescribed by the enforcement agency
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,
including incinerators or steam sterilizers or other treatment
facilities as determined by the enforcement agency, 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 registered hazardous
waste hauler service provided by the building management to which the
building tenants may subscribe or are required by the building
management to subscribe, if applicable.
(h)
(g) The name and business address of the offsite
medical waste treatment facility to which the medical waste is being
hauled, if applicable.
(i)
(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.
(j)
(k) A statement certifying that the information
provided is complete and accurate.
SEC. 22. 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 submit within 30 days an updated
application form when any of the information specified in
subdivisions (a) to (j), inclusive, of Section 117960 changes
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. Section 117975 of the Health
and Safety Code is repealed.
117975. A medical waste generator required to register pursuant
to this chapter shall maintain individual treatment, and tracking
records, if medical waste is removed from the generator's site for
treatment, for three years or for the period specified in the
regulations.
SEC. 24. 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. 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. 26. Section 118025 of the Health
and Safety Code is amended to read:
118025. All medical waste shall be hauled by either
a registered hazardous waste hauler or by a person with an
approved limited-quantity exemption granted pursuant to
Section 118030 exception granted pursuant to Section
117946 for small quantity generators or pursuant to Section 117976
for large quantity generators .
SEC. 6. SEC. 27. 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.
SEC. 7. SEC. 28. 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. 8. SEC. 29. 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.