Bill Text: CA SB26 | 2009-2010 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Hazardous waste: household hazardous waste collection

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Engrossed - Dead) 2010-06-22 - Set, first hearing. Hearing canceled at the request of author. [SB26 Detail]

Download: California-2009-SB26-Amended.html

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BILL NUMBER: SB 26	AMENDED
	BILL TEXT

	AMENDED IN SENATE  APRIL 15, 2009

INTRODUCED BY   Senator Simitian

                        DECEMBER 1, 2008

   An act to add Sections 4001.2, 4068.1, and 4146 to the Business
and Professions Code, to amend Sections 117700,  117935,
117945, 117960,  118000, 118040,  118147, and 118165
  and 118147  of, and to add Sections 
117642,  117669, 117748, 117904.5, 118031, and 118041 to,
the Health and Safety Code, and to amend Section 47200 of the Public
Resources Code, relating to pharmaceutical waste.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 26, as amended, Simitian. Home-generated pharmaceutical waste.
   The existing Pharmacy Law establishes the California State Board
of Pharmacy, prescribes the licensing, regulatory, and disciplinary
functions of the board, and authorizes the board to adopt rules and
regulations necessary to administer laws governing the operation of
pharmacies and the dispensing of drugs and devices to the public.
   This bill would require the board to coordinate with other state
agencies, local governments, drug manufacturers, and pharmacies to
develop sustainable, efficient policies and programs to manage
pharmaceutical wastes and the disposal of devices. The bill would
authorize a pharmacy to accept the return of home-generated
pharmaceutical waste and home-generated sharps waste, as defined.
   Existing law, the California Integrated Waste Management Act of
1989, requires the California Integrated Waste Management Board to
adopt regulations that set forth minimum standards for solid waste
management and require assurance of financial ability to pay for
specified injury and property damage claims resulting from the
operation of a disposal facility. The act requires the board to
expend moneys from the Solid Waste Management Account in the
Integrated Waste Management Fund, upon appropriation by the
Legislature, for the making of grants to cities, counties, or other
local agencies with responsibility for solid waste management, and
for local programs to help prevent the disposal of hazardous wastes
at disposal sites, as provided.
   This bill would require that local programs to help prevent the
disposal of home-generated sharps waste and home-generated
pharmaceutical waste at disposal sites also be included among the
types of local programs that may be funded by such a grant.
   Existing law, the Medical Waste Management Act, requires the State
Department of Public Health to regulate the management and handling
of medical waste, as defined. Under existing law, certain items, such
as household waste, are specifically excluded from the definition of
medical waste.
   This bill would also exclude home-generated pharmaceutical waste,
as defined, from the definition of medical waste.
   Existing law regulates the methods of consolidating, storing, and
transporting medical waste and home-generated sharps waste. Violation
of these provisions is a crime.
   This bill would regulate consolidation points for home-generated
pharmaceutical waste, as defined, as well as transportation and
disposal of that waste  by both hazardous waste haulers and
common carriers, as defined  . 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.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


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

  SECTION 1.  Section 4001.2 is added to the Business and Professions
Code, to read:
   4001.2.  To further the purposes of Section 4001.1, and to protect
the public from hazards caused by the improper management and
disposal of  waste drugs and devices  
pharmaceutical waste  , the California State Board of Pharmacy
shall coordinate with other state agencies, local governments, drug
manufacturers, and pharmacies to develop sustainable, efficient
policies and programs to properly manage pharmaceutical wastes and
the disposal of these wastes.
  SEC. 2.  Section 4068.1 is added to the Business and Professions
Code, to read:
   4068.1.  A pharmacy may accept the return of home-generated
pharmaceutical waste, as defined in Section 117769 of the Health and
Safety Code, from the public.
  SEC. 3.  Section 4146 is added to the Business and Professions
Code, to read:
   4146.  A pharmacy may accept the return of home-generated sharps
waste, as defined in Section 117671 of the Health and Safety Code,
from a person if the waste is contained in a sharps container.

  SEC. 4.    Section 117642 is added to the Health
and Safety Code, to read:
   117642.  "Common carrier" means a person or company that hauls for
hire goods, including, but not limited to, pharmaceutical waste or
home-generated pharmaceutical waste. Home-generated pharmaceutical
waste must have been consolidated at a location approved by the
enforcement agency as a home-generated pharmaceutical waste
consolidation point. 
   SEC. 5.   SEC. 4.   Section 117669 is
added to the Health and Safety Code, to read:
   117669.  "Home-generated pharmaceutical waste" means 
prescribed and over-the-counter drugs   pharmaceutical
waste  derived from a household.
   SEC. 6.   SEC. 5.   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.
   (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.
   (c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
or vomitus, unless it contains fluid blood, as provided in
subdivision (d) of Section 117635.
   (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 home-generated pharmaceutical waste,
as defined in Section 117669.
   (f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a farm or
ranch.
   SEC. 7.   SEC. 6.   Section 117748 is
added to the Health and Safety Code, to read:
   117748.  "Pharmaceutical waste" means any pharmaceutical,
prescription, or over-the-counter human or veterinary drug,
including, but not limited to, a drug, as defined in Section 109925,
or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(g)
(1)) that meets any of the following requirements: 
   (a) The drug may no longer be sold or dispensed because it has
expired.  
   (b) 
    (a)  The drug can no longer be used for its intended
purpose. 
   (c) 
    (b)  The drug has been discarded. 
   (d) 
    (c)  The drug has been consolidated at a location
approved by the enforcement agency as a home-generated pharmaceutical
waste consolidation point.
   SEC. 8.   SEC. 7.   Section 117904.5 is
added to the Health and Safety Code, to read:
   117904.5.  (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 pharmaceutical waste. These locations may include, but
are not limited to, pharmacies, heath care facilities, veterinarian
offices, clinics, household hazardous waste programs, solid waste
facilities,  senior centers   nursing homes
 , or government offices.
   (b) A consolidation location approved pursuant to this section
shall be known as a home-generated pharmaceutical waste consolidation
point.
   (c) A home-generated pharmaceutical waste consolidation point is
not subject to the requirements of Chapter 9 (commencing with Section
118275) of Part 14 of Division  4   104  ,
to the permit requirements of this part, or to any permit or
registration fees, with regard to the activity of consolidating
home-generated pharmaceutical waste pursuant to this section.
   (d) A home-generated pharmaceutical waste consolidation point
shall comply with all of the following requirements:
   (1) It shall be approved by the enforcement agency for this
purpose.
   (2) The home-generated pharmaceutical waste collected and
consolidated at the facility shall be collected and contained in a
leak-resistant  and tamper-proof container and placed in a
secure area that does not allow the waste to be accessed or salvaged
by unauthorized persons.
   (3) Containers ready for disposal shall not be held for more than
90 days without the written approval of the enforcement agency.
   (e) An operator of a home-generated pharmaceutical waste
consolidation point that is approved pursuant to this section shall
not be considered a generator of that waste.
   (f) The end disposal facility that treats the home-generated
pharmaceutical waste shall maintain the tracking documents required
by Section 118040 or 118041, as applicable, and Section 118165 with
regard to the pharmaceutical waste.
   (g) Nothing in this section shall exempt any person from any
federal or state law governing pharmaceuticals. 
  SEC. 9.    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.

   (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. 10.    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, and the name of the registered hazardous waste hauler or
individual hauling the waste pursuant to Section 118030, or the name
of the common carrier hauling pharmaceutical waste pursuant to
Section 118031. The small quantity generator shall maintain these
records for not less than two years.  
  SEC. 11.    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, or the name of the common
carrier hauling pharmaceutical waste pursuant to Section 118031.
   (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. 12.   SEC. 8.   Section 118000 of
the Health and Safety Code is amended to read:
   118000.  (a) Except as otherwise exempted pursuant to Section
118030 or 118031, 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 home-generated
pharmaceutical waste pursuant to Section 118031, 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. 13.    Section 118031 is added to the Health
and Safety Code, to read:
   118031.  Pharmaceutical waste may be shipped by a common carrier
if the generator or home-generated pharmaceutical waste consolidation
point meets the following requirements:
   (a) The facility shall maintain documentation as required in
Sections 118040 and 118041.
   (b) The waste products are transported to any of the following:
   (1) A medical waste facility.
   (2) A hazardous waste facility.
   (3) A reverse distributor, with the final destination of a medical
or hazardous waste facility. 
   SEC. 9.    Section 118031 is added to the  
Health and Safety Code   , to read:  
   118031.  (a) Except for a person who generated the home-generated
pharmaceutical waste, or a family member or other designated person
who is not subject to this part, no person may transport
home-generated pharmaceutical waste unless the person is one of the
following:
   (1) A currently registered hazardous waste hauler.
   (2) In possession of a limited-quantity hauling exemption granted
pursuant to Section 118030, provided that the person may transport no
more than five pounds of home-generated pharmaceutical waste.
   (3) An operator of a home-generated pharmaceutical waste
consolidation point provided that the person transports the
home-generated pharmaceutical waste only from the consolidation point
to a permitted treatment facility or transfer station and maintains
tracking documentation, as required by Sections 118040 and 118041.
   (b) Nothing in this section shall prohibit the operator of a
home-generated pharmaceutical waste consolidation point from using a
registered hazardous waste hauler for transporting the home-generated
pharmaceutical waste to a permitted medical waste treatment or
transfer station facility. 
   SEC. 14.   SEC. 10.   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, pharmaceutical waste or home-generated pharmaceutical
waste consolidated by a home-generated pharmaceutical waste
consolidation point approved pursuant to Section 117904.5, or
home-generated pharmaceutical waste transported pursuant to Section
118031, 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 and quantity 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. 15.   SEC. 11.   Section 118041 is
added to the Health and Safety Code, to read:
   118041.  (a) A person transporting pharmaceutical waste shall
maintain a completed tracking document of all pharmaceutical waste
removed for treatment or disposal. A copy of the tracking document
shall be included with the container holding the pharmaceutical
waste.
   (b) The tracking document shall include, but not be limited to,
all of the following information:
   (1) The name, address, and telephone number of the generator.
   (2) Specific information indicating that pharmaceutical waste is
being transported.
   (3) The name, address, and telephone number of the person
transporting the waste.
   (4) The name, address, telephone number, and permit number of the
permitted treatment facility or transfer station to which the
pharmaceutical waste is being sent.
   (5) The date that the pharmaceutical waste was collected or
removed from the generator or home-generated pharmaceutical waste
consolidation point. 
   (6) The amount of pharmaceutical waste being transported. 
   (c) A person  tracking   transporting 
pharmaceutical waste shall have a tracking document for the waste in
his or her possession while transporting the waste. The tracking
document shall be shown, upon demand, to any enforcement agency
personnel or officer of the Department of the California Highway
Patrol.
   (d) A medical waste treatment facility and transfer station shall
 verify the amount of pharmaceutical waste being delivered, 
date and sign a copy of the tracking document upon receipt,
periodically provide data in a format determined by the department,
and shall maintain a copy of the tracking document for three years.
   (e) This section 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 for the purpose of
consolidation before treatment and disposal of the pharmaceutical
waste over a period of time, if the form or log is maintained in the
files of the parent organization or other health care facility that
receives the waste.
   (f) Pharmaceutical 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 waste is
crossing an international border, the home-generated pharmaceutical
waste shall be treated pursuant to Section 118222 prior to being
transported out of state.   receiving state. 
   SEC. 16.   SEC. 12.   Section 118147 of
the Health and Safety Code is amended to read:
   118147.  Notwithstanding any other provision of this chapter, a
registered medical waste generator, which is a facility specified in
subdivisions (a) and (b) of Section 117705, may accept home-generated
sharps waste and home-generated pharmaceutical waste, to be
consolidated with the facility's medical waste stream, subject to all
of the following conditions:
   (a) The generator of the home-generated sharps waste or
home-generated pharmaceutical waste, a member of the generator's
family, or a person authorized by the enforcement agency transports
the sharps waste or pharmaceutical waste to the medical waste
generator's facility.
   (b) The home-generated sharps waste or home-generated
pharmaceutical waste is accepted at a central location at the medical
waste generator's facility.
   (c) A reference to, and a description of, the actions taken
pursuant to this section are included in the facility's medical waste
management plan adopted pursuant to Section 117960. 
  SEC. 17.    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 or from hazardous
waste haulers or common carriers, pursuant to Section 118041.

   SEC. 18.   SEC. 13.   Section 47200 of
the Public Resources Code is amended to read:
   47200.  (a) The board shall expend funds from the account, upon
appropriation by the Legislature, for the making of grants to cities,
counties, or other local agencies with responsibility for solid
waste management, and for local programs to help prevent the disposal
of home-generated sharps waste, as defined in Section 117671 of the
Health and Safety Code,  home-generated pharmaceutical waste,
as defined in Section 117669 of the Health and Safety Code,
 and hazardous wastes at disposal sites, including, but not
limited to, programs to expand or initially implement household
hazardous waste programs. In making grants pursuant to this section,
the board shall give priority to funding programs that provide for
the following:
   (1) New programs for rural areas, underserved areas, and for small
cities.
   (2) Expansion of existing programs to provide for the collection
of additional waste types, innovative or more cost-effective
collection methods, or expanded public education services.
   (3) Regional household hazardous waste programs.
   (b) (1) The total amount of grants made by the board pursuant to
this section shall not exceed, in any one fiscal year, three million
dollars ($3,000,000).
   (2) Notwithstanding paragraph (1), the total amount of grants made
by the board pursuant to this section may exceed three million
dollars ($3,000,000) but shall not exceed six million dollars
($6,000,000), in any one fiscal year, if sufficient funds are
appropriated from the Integrated Waste Management Account for this
purpose.
   SEC. 19.   SEC. 14.   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.