Amended in Assembly June 23, 2015

Amended in Assembly June 8, 2015

Senate Bill No. 225

Introduced by Senator Wieckowski

February 13, 2015

An act to amend Sections begin delete 117630 end delete begin insert 117630, 117700, 117935, 117960, 118040, end insert and 118275 of the Health and Safety Code, relating to medical waste.

LEGISLATIVE COUNSEL’S DIGEST

SB 225, as amended, Wieckowski. Medical waste.

begin delete

Existing

end delete

begin insert (1) end insert begin insert   end insert begin insert Existing end insert 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 begin insert revise the definition of “biohazard bag” and would end insert 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 begin delete roadways. end delete begin insert 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. end insert The bill would also make a clarifying change to the labeling requirement for containers for nonradioactive pharmaceutical waste.

begin insert

(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.

end insert begin insert

This bill would exclude controlled substances from the definition of medical waste.

end insert begin insert

(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.

end insert begin insert

This bill would remove the requirement that the waste management plans include the steps taken to categorize the pharmaceutical wastes generated at the facility.

end insert begin insert

(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.

end insert begin insert

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.

end insert

Vote: majority. Appropriation: no. Fiscal committee:  begin delete no end delete begin insert yes end insert . 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.  

begin insert (a) end insert begin insert   end insert “Biohazard bag” means a disposable film bag begin delete that
is impervious to moisture. end delete begin insert used to contain medical waste. end insert The film
bags that are used begin insert to line the United States Department of
Transportation (USDOT)-approved shipping containers end insert for
transport from the generator’s facility onto roadways begin insert and into
commerce to a treatment and disposal facility end insert 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. begin delete 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. end delete

begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 117700 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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 begin delete which end delete begin insert that end insert 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 begin insert , and controlled substances end insert .

(f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a farm
or ranch unless otherwise specified in law.

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 117935 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin delete

(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.

end delete begin delete

(j)

end delete

begin insert (i) end insert  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.

begin delete

(k)

end delete

begin insert (j) end insert  A statement certifying that the information provided is
complete and accurate.

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert Section 117960 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin delete

(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.

end delete begin delete

(j)

end delete

begin insert (i) end insert  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.

begin delete

(k)

end delete

begin insert (j) end insert  A statement certifying that the information provided is
complete and accurate.

begin insert

begin insert SEC. 5. end insert   

end insert

begin insert Section 118040 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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 begin delete or generator end delete
transporting medical waste shall maintain a completed shipping
document in compliance with United States Department of
Transportation (USDOT) requirements when medical waste is
transported begin insert on a public roadway end insert . In addition to the shipping
document required by USDOT, a hazardous waste transporter begin delete or
generator end delete who transports medical waste to a facility, other than
the final medical waste treatment facility, shall also maintain
tracking begin delete documents which show end delete begin insert information that shows end insert 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 begin insert document end insert and tracking
begin delete documents end delete begin insert document, if the waste is transported to a facility other
than the final medical waste treatment facility end insert for the generator’s
medical waste records. begin insert Information from the shipping document
and the tracking document may be combined onto one form having
the required information. end insert The transporter begin delete or generator end delete transporting
medical waste shall maintain its copy of the begin delete shipping and tracking end delete
begin insert shipping, tracking, and combined end insert 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 begin delete Section
118030. end delete begin insert Section 117946 or 117976. end insert

(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)   begin delete Any end delete begin insert A end insert 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.

begin delete SEC. 2. end delete
begin insert SEC. 6. end insert   

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 begin delete conspicuously labeled with the words “Biohazardous Waste”
or with the international biohazard symbol and the word
“BIOHAZARD.” end delete begin insert and labeled in compliance with Section 117630. end insert

(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 begin delete and United States
Drug Enforcement Agency (DEA) end delete requirements.

begin delete

(A) Pharmaceutical wastes classified by the DEA as “controlled
substances” shall be disposed of in compliance with DEA
requirements.

end delete begin delete

(B) Nonradioactive

end delete

begin insert Nonradioactive end insert 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.