BILL NUMBER: SB 225 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 23, 2015
AMENDED IN ASSEMBLY JUNE 8, 2015
INTRODUCED BY Senator Wieckowski
FEBRUARY 13, 2015
An act to amend Sections 117630 117630,
117700, 117935, 117960, 118040, and 118275 of the Health and
Safety Code, relating to medical waste.
LEGISLATIVE COUNSEL'S DIGEST
SB 225, as amended, Wieckowski. Medical waste.
Existing
(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." Existing law defines a biohazard bag
to mean a film bag that is impervious to moisture. Existing law
requires the film bags that are used for transport to be marked and
certified by the manufacturer as having passed specified tests
prescribed for tear resistance and for impact resistance. Existing
law also imposes a specified labeling requirement on containers for
nonradioactive pharmaceutical wastes that are not subject to a
specified federal law and that are regulated as medical waste.
This bill would revise the definition of "biohazard bag" and
would limit the application of the requirement that film bags
used for transport be marked and certified by the manufacturer as
having passed specified tests only to those film bags that are used
for transport from the generator's facility onto roadways.
roadways and into commerce to a treatment and disposal
facility. The bill would revise the requirements for film bags that
are used to collect medical waste within a facility and small
biohazard bags, as specified. The bill would also make a
clarifying change to the labeling requirement for containers for
nonradioactive pharmaceutical waste.
(2) Existing law defines medical waste and specifically excludes
from that definition hazardous waste, radioactive waste, or household
waste, including, but not limited to, home-generated sharps waste.
This bill would exclude controlled substances from the definition
of medical waste.
(3) Existing law requires small and large quantity generators to
file with the enforcement agency a medical waste management plan
containing specified information, including, if applicable, the steps
taken to categorize the pharmaceutical wastes generated at the
facility to ensure that the wastes are properly disposed of as
prescribed.
This bill would remove the requirement that the waste management
plans include the steps taken to categorize the pharmaceutical wastes
generated at the facility.
(4) Existing law requires a hazardous waste transporter or
generator transporting medical waste to maintain a completed shipping
document in compliance with the United States Department of
Transportation and a tracking document if the waste is transported to
a facility other than the final medical waste treatment facility.
This bill would require a shipping document only when a hazardous
waste transporter transports medical waste on a public roadway. The
bill would also require the shipping document and tracking
information to be maintained only by hazardous waste transporters,
and not by generators transporting waste.
Vote: majority. Appropriation: no. Fiscal committee: no
yes . State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 117630 of the Health and Safety Code is amended
to read:
117630. (a) "Biohazard bag" means a
disposable film bag that is impervious to moisture.
used to contain medical waste. The film bags
that are used to line the United States Department of
Transportation (USDOT)-approved shipping containers for
transport from the generator's facility onto roadways and into
commerce to a treatment and disposal facility 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 D1709, "Standard Test Methods for
Impact Resistance of Plastic Film by the Free-Falling Dart Method,"
as those documents were 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 yellow bags are used to further segregate trace
chemotherapy waste and white bags are used to further segregate
pathology waste.
(b) The film bag that is used to collect medical waste within a
facility shall only be required to be marked and certified by the
manufacturer to meet the ASTM D1709 dart drop test, provided that
when the bag is prepared for transport off-site, it is placed into a
USDOT-approved container lined with a biohazard bag that is ASTM
D1709 and ASTM D1922 certified.
(c) Small biohazard bags used for the collection of medical waste
in small waste containers, including, but not limited to, exam and
patient rooms, kickbuckets, and benchtop waste containers, shall not
be required to be ASTM D1709 or ASTM D1922 certified, provided that
the bag has strength sufficient to preclude ripping, tearing,
leaking, or bursting under normal conditions and the bags from these
containers are placed into a larger container lined with an ASTM
D1709 marked and certified film bag or a USDOT-approved shipping
container lined with an ASTM D1709 and ASTM D1922 certified bag.
(d) The color of the bag shall be red, except when yellow bags are
used to further segregate trace chemotherapy waste and white bags
are used to further segregate pathology waste. The biohazard bag
shall be marked with the international biohazard symbol and may be
labeled as regulated medical waste, biomedical waste, biohazardous
waste, infectious waste, clinical waste, infectious substance, or
other language as authorized by the USDOT.
SEC. 2. 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, as
defined in Section 117665.
(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 or recognizable fluid blood,
as provided in subparagraph (C) of paragraph (1) of subdivision (b)
of Section 117690.
(d) Waste which that 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 , and controlled substances .
(f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a farm or
ranch unless otherwise specified in law.
SEC. 3. Section 117935 of the Health
and Safety Code is amended to read:
117935. A 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, if provided. The plans shall
contain, but are 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.
(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, if applicable.
(h) The name of the common carrier used by the generator to
transport pharmaceutical waste offsite for treatment and disposal
pursuant to Section 118032, if applicable.
(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 registered 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)
(i) A closure plan for the termination of treatment at
the facility using, at a minimum, one of the methods of
decontamination specified in subdivision (a) or (b) of Section
118295, thereby rendering the property to an acceptable sanitary
condition following the completion of treatment services at the site.
(k)
(j) A statement certifying that the information
provided is complete and accurate.
SEC. 4. Section 117960 of the Health
and Safety Code is amended to read:
117960. A large quantity generator required to register with the
enforcement agency shall file with the enforcement agency a medical
waste management plan, on forms prescribed by the enforcement agency,
if provided. The plans shall contain, but are 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)
(i) A closure plan for the termination of treatment at
the facility using, at a minimum, one of the methods of
decontamination specified in subdivision (a) or (b) of Section
118295, thereby rendering the property to an acceptable sanitary
condition following the completion of treatment services at the site.
(k)
(j) A statement certifying that the information
provided is complete and accurate.
SEC. 5. Section 118040 of the Health
and Safety Code is amended to read:
118040. (a) Except with regard to sharps waste consolidated by a
home-generated sharps consolidation point approved pursuant to
Section 117904, a hazardous waste transporter or generator
transporting medical waste shall maintain a completed
shipping document in compliance with United States Department of
Transportation (USDOT) requirements when medical waste is transported
on a public roadway . In addition to the shipping
document required by USDOT, 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
information that shows 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 shipping
document and tracking documents
document, if the waste is transported to a facility other
than the final medical waste treatment facility for the
generator's medical waste records. Information f rom
the shipping document and the tracking document may be combined onto
one form having the required information. The transporter
or generator transporting medical waste shall
maintain its copy of the shipping and tracking
shipping, tracking, and combined documents 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. Section 117946 or 117976.
(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 A hazardous waste
transporter or generator transporting medical waste in a vehicle
shall have the shipping and tracking documents 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 shipping and tracking documents.
(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.
SEC. 2. SEC. 6. Section 118275 of
the Health and Safety Code is amended to read:
118275. (a) To containerize or store medical waste, at the point
of generation and while collected in that room, a person shall do all
of the following:
(1) Medical waste, as defined in Section 117690, shall be
contained separately from other waste at the point of origin in the
producing facility. Sharps containers may be placed in biohazard bags
or in containers with biohazard bags.
(2) Biohazardous waste, as defined in paragraph (1) of subdivision
(b) of Section 117690, shall be placed in a biohazard bag
conspicuously labeled with the words "Biohazardous Waste" or with the
international biohazard symbol and the word "BIOHAZARD."
and labeled in compliance with Section 117630.
(3) Sharps waste, as defined in paragraph (4) of subdivision (b)
of Section 117690, including sharps and pharmaceutical waste
containerized pursuant to paragraph (7), shall be contained in a
United States Food and Drug Administration (USFDA) approved sharps
container that meets USFDA labeling requirements and is handled
pursuant to Section 118285.
(4) Trace chemotherapy waste, as defined in paragraph (5) of
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 "Chemotherapy Waste," "CHEMO," or other label
approved by the department on the lid and sides, so as to be visible
from any lateral direction, to ensure treatment of the biohazardous
waste pursuant to Section 118222. Sharps waste that is contaminated
through contact with, or having previously contained,
chemotherapeutic agents, shall be placed in sharps containers labeled
in accordance with the industry standard with the words
"Chemotherapy Waste," "CHEMO," or other label approved by the
department, and shall be segregated to ensure treatment of the sharps
waste pursuant to Section 118222.
(5) Pathology waste, as defined in paragraph (2) of 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 sides, so as to be visible from any lateral
direction, to ensure treatment of the waste pursuant to Section
118222.
(6) Pharmaceutical waste, as defined in paragraph (3) of
subdivision (b) of Section 117690, shall be segregated for storage in
accordance with the facility's medical waste management plan. When
this waste is prepared for shipment offsite for treatment, it shall
be properly containerized for shipment 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
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 "HIGH HEAT" or "INCINERATION ONLY," or with another label
approved by the department, on the lid and sides, so as to be visible
from any lateral direction, to ensure treatment of the biohazardous
waste pursuant to Section 118222.
(7) A person may consolidate into a common container, which may be
reusable, sharps waste, as defined in paragraph (4) of subdivision
(b) of Section 117690, and pharmaceutical wastes, as defined in
paragraph (3) of subdivision (b) of Section 117690, provided that
both of the following apply:
(A) The consolidated waste is treated by incineration or
alternative treatment technologies approved to treat that waste
pursuant to paragraph (1) or (3) of subdivision (a) of Section 118215
prior to disposal. That alternative treatment shall render the waste
unrecoverable and nonhazardous.
(B) The container meets the requirements of Section 118285. The
container shall be labeled with the biohazardous waste symbol and the
words "HIGH HEAT" or "INCINERATION ONLY," or with another label
approved by the department, on the lid and sides, so as to be visible
from any lateral direction, to ensure treatment of the waste
pursuant to this subdivision.
(b) To containerize medical waste being held for shipment offsite
for treatment, the waste shall be labeled, as outlined in subdivision
(a), on the lid and 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.