BILL NUMBER: AB 1442	CHAPTERED
	BILL TEXT

	CHAPTER  689
	FILED WITH SECRETARY OF STATE  SEPTEMBER 28, 2012
	APPROVED BY GOVERNOR  SEPTEMBER 28, 2012
	PASSED THE SENATE  AUGUST 27, 2012
	PASSED THE ASSEMBLY  AUGUST 29, 2012
	AMENDED IN SENATE  AUGUST 21, 2012
	AMENDED IN SENATE  AUGUST 6, 2012
	AMENDED IN SENATE  JUNE 14, 2012
	AMENDED IN ASSEMBLY  MARCH 27, 2012
	AMENDED IN ASSEMBLY  FEBRUARY 6, 2012

INTRODUCED BY   Assembly Member Wieckowski
   (Coauthors: Assembly Members Allen and Williams)

                        JANUARY 4, 2012

   An act to amend Sections 117935, 117945, 117960, 118000, 118040,
and 118165 of, and to add Sections 117637, 117748, 118032, and 118033
to, the Health and Safety Code, relating to pharmaceutical waste.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1442, Wieckowski. Pharmaceutical waste.
   The existing Medical Waste Management Act, administered by the
State Department of Public Health, regulates the management and
handling of medical waste, as defined. Existing law requires that all
medical waste be hauled by either a registered hazardous waste
hauler or by a person with an approved limited-quantity exemption
granted pursuant to specified provisions of law. Violation of these
provisions of law is a crime.
   This bill would define pharmaceutical waste for purposes of the
Medical Waste Management Act, and would exempt a pharmaceutical waste
generator or parent organization that employs health care
professionals who generate pharmaceutical waste from specified
medical waste hauling requirements if the generator, health care
professional, or parent organization retains specified documentation
and meets specified requirements and if the facility receiving the
medical waste retains specified documentation and meets specified
requirements. The bill would authorize pharmaceutical waste to be
transported by the generator or health care professional who
generated the pharmaceutical waste, a staff member of the generator
or health care professional, or common carrier, as defined, pursuant
to these provisions. By expanding the definition of a crime, this
bill would impose 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.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 117637 is added to the Health and Safety Code,
to read:
   117637.  "Common carrier" means either of the following:
   (a) A person or company that has a United States Department of
Transportation number issued by the Federal Motor Carrier Safety
Administration and is registered with the Federal Motor Carrier
Safety Administration as a for-hire property carrier.
   (b) A person or company that has a motor carrier of property
permit issued by the Department of Motor Vehicles pursuant to the
Motor Carriers of Property Permit Act (Division 14.85 (commencing
with Section 34600) of the Vehicle Code) and, if applicable, a
carrier identification number issued by the Department of the
California Highway Patrol pursuant to Section 34507.5 of the Vehicle
Code.
  SEC. 2.  Section 117748 is added to the Health and Safety Code, to
read:
   117748.  (a) "Pharmaceutical waste" means any pharmaceutical, as
defined in Section 117747, that is a waste, as defined in Section
25124.
   (b) For purposes of this part, "pharmaceutical waste" does not
include any pharmaceutical that meets either of the following
criteria:
   (1) The pharmaceutical is being sent out of the State of
California to a reverse distributor, as defined in Section 4040.5 of
the Business and Professions Code, that is licensed as a wholesaler
of dangerous drugs by the California State Board of Pharmacy pursuant
to Section 4161 of the Business and Professions Code.
   (2) The pharmaceutical is being sent by a reverse distributor, as
defined in Section 4040.5 of the Business and Professions Code,
offsite for treatment and disposal in accordance with applicable
laws, or to a reverse distributor that is licensed as a wholesaler of
dangerous drugs by the California State Board of Pharmacy pursuant
to Section 4160 of the Business and Professions Code and as a
permitted transfer station if the reverse distributor is located
within the State of California.
  SEC. 3.  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:
   (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 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 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) A statement certifying that the information provided is
complete and accurate.
  SEC. 4.  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 of any medical waste transported 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.
  SEC. 5.  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 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) The name and business address of the offsite medical waste
treatment facility to which the medical waste is being hauled, if
applicable.
   (i) An emergency action plan complying with regulations adopted by
the department.
   (j) A statement certifying that the information provided is
complete and accurate.
  SEC. 6.  Section 118000 of the Health and Safety Code is amended to
read:
   118000.  (a) Except as otherwise exempted pursuant to Section
118030 or 118032, all medical waste transported to an offsite medical
waste treatment facility shall be transported in accordance with
this chapter by a registered hazardous waste transporter issued a
registration certificate pursuant to Chapter 6 (commencing with
Section 118025) and Article 6.5 (commencing with Section 25167.1) of
Chapter 6.5 of Division 20. A hazardous waste transporter
transporting medical waste shall have a copy of the transporter's
valid hazardous waste transporter registration certificate in the
transporter's possession while transporting medical waste. The
transporter shall show the certificate, upon demand, to any
enforcement agency personnel or authorized employee of the Department
of the California Highway Patrol.
   (b) Except for small quantity generators transporting medical
waste pursuant to Section 118030 or small quantity generators or
common carriers transporting pharmaceutical waste pursuant to Section
118032, medical waste shall be transported to a permitted offsite
medical waste treatment facility or a permitted transfer station in
leak-resistant and fully enclosed rigid secondary containers that are
then loaded into an enclosed cargo body.
   (c) A person shall not transport medical waste in the same vehicle
with other waste unless the medical waste is separately contained in
rigid containers or kept separate by barriers from other waste, or
unless all of the waste is to be handled as medical waste in
accordance with this part.
   (d) Medical waste shall only be transported to a permitted medical
waste treatment facility, or to a transfer station or another
registered generator for the purpose of consolidation before
treatment and disposal, pursuant to this part.
   (e) Facilities for the transfer of medical waste shall be annually
inspected and issued permits in accordance with the regulations
adopted pursuant to this part.
   (f) Any persons manually loading or unloading containers of
medical waste shall be provided by their employer at the beginning of
each shift with, and shall be required to wear, clean and protective
gloves and coveralls, changeable lab coats, or other protective
clothing. The department may require, by regulation, other protective
devices appropriate to the type of medical waste being handled.
  SEC. 7.  Section 118032 is added to the Health and Safety Code, 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 117915), 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 117915), 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 tracking
document, as specified in Section 118040.
   (2) The generator and the facility receiving the pharmaceutical
waste maintain the tracking 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 tracking 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 tracking 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. 8.  Section 118033 is added to the Health and Safety Code, to
read:
   118033.  The pharmaceutical waste that is separated from medical
waste by the generator shall be maintained in a manner to secure the
pharmaceutical waste contents from access by unauthorized
individuals. Any suspected or confirmed tampering of, unauthorized
access to, or loss of this pharmaceutical waste shall be reported to
the appropriate state licensing authority.
  SEC. 9.  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 tracking
document of all medical waste removed for treatment or disposal. 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 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 tracking document for the generator's
medical waste records. The transporter or generator transporting
medical waste shall maintain its copy of the 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 118030.
   (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 hazardous waste transporter or generator transporting
medical waste in a vehicle shall have a 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 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.
   (f)  Medical waste transported out of state shall be consigned to
a permitted medical waste treatment facility in the receiving state.
If there is no permitted medical waste treatment facility in the
receiving state or if the medical waste is crossing an international
border, the medical waste shall be treated in accordance with Chapter
8 (commencing with Section 118215) prior to being transported out of
the state.
  SEC. 10.  Section 118165 of the Health and Safety Code is amended
to read:
   118165.  On and after April 1, 1991, all persons operating a
medical waste treatment facility shall maintain individual records
for a period of three years and shall report or submit to the
enforcement agency upon request, all of the following information:
   (a) The type of treatment facility and its capacity.
   (b) All treatment facility operating records.
   (c) Copies of the tracking documents for all medical waste it
receives for treatment from offsite generators, hazardous waste
haulers, or, pursuant to Section 118032, common carriers.
  SEC. 11.  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.