BILL NUMBER: SB 225 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JULY 2, 2015
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, 117700, 117935, 117960,
118040, and 118275 of the Health and Safety Code, relating
to medical waste. waste, and declaring the
urgency thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 225, 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." 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 and into
commerce to a treatment and disposal facility. The bill would revise
the requirements for film biohazard
bags that are used to collect medical waste within a
facility and small biohazard bags, facility, 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)
(2) 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.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: majority 2/3 . Appropriation:
no. Fiscal committee: 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 used to
contain medical waste. The Notwithstanding
subdivision (b) of Section 117605, 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.
(b) The film biohazard bag that is
used to collect medical waste within a facility shall only
be required to be marked and be manufacturer
certified by the manufacturer to meet the ASTM
D1709 dart drop test, provided that when the bag is prepared for
transport off-site, offsite, 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)
(c) 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 by reference
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 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) 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.
(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) 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.
(j) A statement certifying that the information provided is
complete and accurate.
SEC. 5. SEC. 2. 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 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
who transports medical waste to a facility, other than the final
medical waste treatment facility, shall also maintain tracking
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 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 from the shipping
document and the tracking document may be combined onto one form
having the required information. The transporter transporting medical
waste shall maintain its copy of the 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 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) 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. 6. SEC. 3. 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 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 the United States Drug
Enforcement Administration (DEA) requirements.
(A) Pharmaceutical wastes classified by the DEA as "controlled
substances" shall be disposed of in compliance with DEA requirements.
Nonradioactive
(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 "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.
SEC. 4. This act is an urgency statute necessary
for the immediate preservation of the public peace, health, or safety
within the meaning of Article IV of the Constitution and shall go
into immediate effect. The facts constituting the necessity are:
In order to ensure that necessary and technical changes to the
laws governing the handling and disposal of medical waste are
implemented as soon as possible, it is necessary that this act take
effect immediately.