BILL NUMBER: SB 225 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 17, 2015
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, 117904, 117943, 117945,
117975, 118032, 118040, 118345, and 118275 of the
Health and Safety Code, relating to medical waste, and declaring the
urgency thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 225, as amended, Wieckowski. Medical waste.
(1) Existing Under existing law, the
Medical Waste Management Act, the California Department of
Public Health regulates the disposal of medical waste,
including requiring waste. The act requires
specified biohazard materials to be disposed of in biohazard bags and
requiring requires 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.
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 biohazard bags that are used to collect medical
waste within a facility, as specified.
(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 instead require a shipping
document only when a hazardous waste transporter that
transports medical waste on a public roadway.
to maintain a tracking document in compliance with
specified requirements for purposes of tracking medical waste from
the point when the waste leaves the generator facility until the
waste receives final treatment. The bill would also require the
shipping document and tracking
information document to be maintained only by
hazardous waste transporters, and not by generators transporting
waste. The bill would also make conforming changes.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: 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. 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 biohazard bag that is used to collect medical waste within
a facility shall be manufacturer certified to meet the ASTM D1709
dart drop test, provided that when the bag is prepared for transport
offsite, it is placed into a USDOT-approved container lined with a
biohazard bag that is ASTM D1709 and ASTM D1922 certified.
(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 by reference as authorized by the USDOT.
SEC. 2. 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 tracking documents in compliance with
United States Department of Transportation and
the United States Postal Service requirements.
requirements for waste shipped through mail back and
on the tracking documents as required by the department.
(f) The medical waste treatment facility which treats the sharps
waste subject to this section shall maintain the shipping
and tracking documents document
required by Sections 118040 and 118165 with regard to that
sharps waste.
SEC. 3. Section 117943 of the Health
and Safety Code is amended to read:
117943. (a) A medical waste generator required to register
pursuant to this chapter shall maintain for a minimum of three years
individual treatment operating records, and if applicable,
shipping and the tracking documents
document for all untreated medical waste shipped
offsite for treatment, and 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 complying with regulations adopted by
the department.
(3) Shipping and tracking Tracking
documents or electronically archived shipping and
tracking documents maintained by the facility and medical waste
hauler of all untreated medical waste shipped offsite for treatment.
(b) Documentation shall be made available to the enforcement
agency onsite.
SEC. 4. Section 117945 of the Health
and Safety Code is amended to read:
117945. (a) Small quantity generators who are not required to
register pursuant to this chapter shall maintain on file in their
office all of following:
(1) 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.
(2) Records required by the United States Department of
Transportation or the United States Postal Service of any
medical waste shipped offsite for treatment and disposal. The small
quantity generator shall maintain, or have available electronically
at the facility or from the medical waste hauler or common carrier,
these records, for not less than three years.
(b) Documentation shall be made available to the enforcement
agency onsite.
SEC. 5. Section 117975 of the Health
and Safety Code is amended 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 and
the tracking documents
document 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 and tracking Tracking
documents or electronically archived shipping and
tracking documents 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. 6. Section 118032 of the Health
and Safety Code is amended to read:
118032. A pharmaceutical waste generator or parent organization
that employs health care professionals who generate pharmaceutical
waste is exempt from the requirements of subdivision (a) of Section
118000 if all of the following requirements are met:
(a) The generator or parent organization has on file one of the
following:
(1) If the generator or parent organization is a small quantity
generator required to register pursuant to Chapter 4 (commencing with
Section 117925), a medical waste management plan prepared pursuant
to Section 117935.
(2) If the generator or parent organization is a small quantity
generator not required to register pursuant to Chapter 4 (commencing
with Section 117925), the information document maintained pursuant to
subdivision (a) of Section 117945.
(3) If the generator or parent organization is a large quantity
generator, a medical waste management plan prepared pursuant to
Section 117960.
(b) The generator or health care professional who generated the
pharmaceutical waste transports the pharmaceutical waste himself or
herself, or directs a member of his or her staff to transport the
pharmaceutical waste to a parent organization or another health care
facility for the purpose of consolidation before treatment and
disposal, or contracts with a common carrier to transport the
pharmaceutical waste to a permitted medical waste treatment facility
or transfer station.
(c) Except as provided in subdivision (d), all of the following
requirements are met:
(1) Prior to shipment of the pharmaceutical waste, the generator
notifies the intended destination facility that it is shipping
pharmaceutical waste to it and provides a copy of the
shipping and tracking documents,
document, as specified in Section 118040.
(2) The generator and the facility receiving the pharmaceutical
waste maintain the shipping and tracking
documents, document, as specified in Section
118040.
(3) The facility receiving the pharmaceutical waste notifies the
generator of the receipt of the pharmaceutical waste shipment and any
discrepancies between the items received and the shipping
and tracking documents, document,
as specified in Section 118040, evidencing diversion of the
pharmaceutical waste.
(4) The generator notifies the enforcement agency of any
discrepancies between the items received and the shipping
and tracking documents, document,
as specified in Section 118040, 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. 2. SEC. 7. 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
tracking 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. subdivision (b) for the purpose of
tracking the medical waste from the point when the waste leaves the
generator facility until it receives final treatment. 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. tracking document. The transporter
transporting medical waste shall maintain its copy of the
shipping, tracking, and combined documents 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 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 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 shipping and
tracking documents. 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.
SEC. 3. SEC. 8. 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.
(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. 9. Section 118345 of the Health
and Safety Code is amended to read:
118345. (a) Any person who intentionally makes any false
statement or representation in any application, label,
shipping document, tracking 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. 4. SEC. 10. 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.