BILL ANALYSIS Ó
AB 2039
Page 1
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Luis Alejo, Chair
AB 2039
(Ting) - As Amended April 5, 2016
SUBJECT: Solid waste: home-generated sharps
SUMMARY: Requires the development and implementation of
industry-generated plans to collect and recycle home-generated
sharps. Specifically, this bill:
1) Declares that it is the intent of the Legislature, in
enacting the Safe Home-Generated Sharps Recovery Program
(Program), to ensure affordable and convenient sharps
collection opportunities, which, in turn, will help prevent
the improper management of those sharps.
2) Repeals the provisions of Senate Bill (SB) 486
(Simitian, Chapter 591, Statutes of 2009), which requires a
pharmaceutical manufacturer that sells or distributes a
medication in California that is usually intended to be
self-injected at home through the use of a hypodermic
needle, pen needle, intravenous needle, or any other
similar device, to submit a plan to the California
Department of Resources Recycling and Recovery (CalRecycle)
that describes the actions taken by the manufacturer to: 1)
support or provide for the safe collection and proper
disposal of the waste devices, and 2) educate consumers
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about safe sharps management and collection opportunities.
3) Authorizes home-generated sharps waste to be managed by
a facility or other home-generated sharps collection point
operated pursuant to a home-generated sharps stewardship
plan.
4) Defines "home-generated sharps stewardship plan" as a
plan submitted by an individual producer or by a
stewardship organization on behalf of one or more
producers.
5) Defines "producer" as: 1) the person who manufactures
home-generated sharps and who sells, offers for sale, or
distributes those home-generated sharps in the state under
that person's own name or brand; 2) if there is no person
who is a producer of the home-generated sharps, it is the
owner or licensee of a trademark or brand under which the
home-generated sharps are sold or distributed in the state,
whether or not the trademark is registered; or, 3) if there
is no person who is a producer of the sharps per 1) and 2)
above, the producer of those sharps is the person who
imports the home-generated sharps into the state for sale
or distribution.
6) Defines "stewardship organization" as either a nonprofit
organization created by one or more producers to act as an
agent on behalf of the producers to design, submit, and
administer a product stewardship plan pursuant to this
chapter; or a producer of a covered product.
7) Requires CalRecycle, on or before January 1, 2018, to
adopt regulations.
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8) Requires, on or before February 1, 2018, CalRecycle to
appoint a stakeholder advisory committee, with
representation from specific sectors, to provide
recommendations and guidance to producers and stewardship
organizations. Requires the stakeholder advisory committee
to annually report to CalRecycle.
9) Requires a pharmaceutical manufacturer that sells or
distributes a medication that is intended to be
self-injected at home to submit to CalRecycle a plan that
describes how the manufacturer supports the safe collection
and proper disposal of the home-generated sharps, on or
before July 1 of each year.
10) Requires, on or before July 1, 2018, a producer or a
stewardship organization designated by a producer, to
submit a home-generated sharps stewardship plan to
CalRecycle.
11) Requires the producer or stewardship organization to
consult with the stakeholder advisory committee as it
develops its stewardship plan. Requires the plan to provide
for the development and implementation of a recovery
program to reduce the generation of, and manage the end of
life of, home-generated sharps in an environmentally sound
and medically safe manner.
12) Specifies that the stewardship plan must contain the
following elements:
a. Contact information for all participating
producers;
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b. Procedures for calculating the amount, by
weight, of the home-generated sharps subject to the
plan;
c. Provisions for meeting specified collection
targets;
d. A demonstration of sufficient funding to
implement the plan;
e. Coordination of the home-generated sharps
stewardship plan with existing household hazardous
waste (HHW) and other local collection programs;
f. Programs to reduce the number of
home-generated sharps that are illegally disposed of,
and to maximize the proper end of life management of
home-generated sharps;
g. Education and outreach efforts;
h. Methods for demonstrating that the program
implemented achieves the maximum improvement possible
on the improper disposal of home-generated sharps;
i. The establishment of at least one
home-generated sharps collection point in every county
in the state, but no less than one home-generated
sharps collection point for every 25,000 people in
each county; and,
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j. Procedures for complying with all applicable
state and federal laws and regulations for the
collection, consolidation, transportation, and
recycling or disposal of home-generated sharps waste.
13) Requires CalRecycle to review a home-generated sharps
stewardship plan within 60 days of receipt. Specifies
timelines for approval and for requiring resubmission of a
revised stewardship plan.
14) Requires an approved plan to be public record, except
for any financial, production, or sales data reported to
CalRecycle by the producer or stewardship organization.
15) Requires, on or before January 1, 2019, or three months
after a plan is approved, whichever is later, but no later
than April 1, 2019, the producer or stewardship
organization to implement the home-generated sharps
stewardship program described in the plan.
16) Authorizes a retailer to voluntarily participate as a
home-generated sharps collection point pursuant to the
home-generated sharps program.
17) Requires CalRecycle, on or before January 1, 2023, to
consult with producers, stewardship organizations, the
stakeholder advisory committee, and all other stakeholders
regarding the Program's performance.
18) Requires CalRecycle, once the plan is approved, to post
on its Internet Website a list of producers covered under
the plan.
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19) Requires, on or before April 1, 2020, and annually
thereafter, each producer or stewardship organization
implementing a plan to prepare and submit to CalRecycle an
annual report with information describing the activities
carried out pursuant to the plan and specific
recommendations from the stakeholder advisory committee
that were accepted or rejected by the stewardship
organization.
20) Requires CalRecycle to review and approve or disapprove
the annual report and review the accuracy of the list of
home-generated sharps collection points that are certified
to be established pursuant to the plan.
21) Authorizes CalRecycle, if the annual report does not
demonstrate that the applicable program has achieved the
collection rate increase as required pursuant to
aforementioned collection targets, to require additional
actions to improve collection rates.
22) Requires a report deemed approved by CalRecycle if
CalRecycle does not disapprove a report within 45 days of
receipt. Requires all approved reports to be posted on
CalRecycle's Website for one year.
23) Requires a producer or stewardship organization
submitting a plan to CalRecycle to pay an annual
administrative fee, which shall be set at an appropriate
amount to cover CalRecycle's administrative costs.
24) Establishes the Safe Sharps Disposal Account within the
Integrated Waste Management Fund and requires the
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administrative fees to be deposited into that Account.
25) Authorizes CalRecycle to enforce this article and impose
a civil penalty of up to $1,000 per violation per day.
Authorizes CalRecycle to impose a civil penalty on a person
who knowingly and intentionally violates this article of up
to $10,000 per violation per day.
26) Establishes the Safe Sharps Disposal Penalty Account
within the Integrated Waste Management Fund and requires
all penalties to be deposited into that Account.
27) States that any action by a producer, stewardship
organization, or retailer is not a violation of the
Cartwright Act (Business & Professions Code (B&P) § 16700,
et seq.) or the Unfair Practices Act (B&P 1700, et seq.).
EXISTING LAW:
1) Authorizes a city and a county HHW element to include a
program for the safe collection, treatment, and disposal of
sharps waste generated by households. (Public Resources
Code (PRC) § 41502)
2) Requires manufacturers of self-injectable medications to
annually submit a plan describing how it provides for the
safe collection and proper disposal of medical sharps. (PRC
§ 47115)
3) Requires each county to prepare a HHW element which
identifies a program for the safe collection, recycling,
treatment, and disposal of hazardous wastes, which are
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generated by households in the city and which should be
separated from the solid waste stream. (PRC § 41510)
4) Defines "home-generated sharps waste" as hypodermic
needles, pen needles, intravenous needles, lancets, and
other devices that are used to penetrate the skin for the
delivery of medications derived from a household, including
a multifamily residence or household. (Health & Safety Code
(H&S) § 117671)
5) Prohibits the disposal of home-generated sharps waste in
the trash or recycling containers, and requires that all
sharps waste be transported to a collection center in a
sharps container approved by the local enforcement agency.
(H&S § 118286)
6) Pursuant to the Medical Waste Management Act (MWMA) (H&S
§ 117600, et seq.):
a. Defines "medical waste" as including waste
generated from the consolidation of home-generated
sharps. (H&S § 117690)
b. Authorizes a registered medical waste
generator to accept and consolidate home-generated
sharps waste with the facility's medical waste stream
under specified conditions. (H&S § 118147)
c. Requires a person generating or treating
sharps waste to ensure that the medical waste is
treated to render it solid waste prior to disposal.
(H&S § 118215)
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d. Requires sharps waste to be rendered
noninfectious prior to disposal by a specified
treatment method. (H&S § 118225)
e. Specifies containerization, storage and
labeling requirements for sharps waste. (H&S §
1118275, 118285, and 118286)
f. Authorizes a local enforcement agency to
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. (H&S § 117904)
FISCAL EFFECT: Unknown.
COMMENTS:
Need for the bill: According to the author, "AB 2039 requires
sharps manufacturers to design, fund, and administer a take-back
program to safely collect and dispose of home-generated sharps
to keep them out of the trash ? California has set a goal to
recycle 75% of waste by 2020, which will require a great deal
more of hand sorting of our waste stream. Inaction on sharps
disposal leaves some workers over-exposed to health dangers, a
risk compounded by the growing use of home-generated sharps. We
must remove sharps from the waste stream on the front end so
that important state recycling goals are not unintentionally at
cross purposes with worker safety."
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Medical sharps: An estimated one million Californians inject
medications outside traditional health care facilities, which
generate approximately 936 million sharps each year, and the
numbers of patients using injectable medications will continue
to grow because it is an effective delivery method for various
medications. The most common home use of sharps is to manage
diabetes. Other reasons to inject at home include hepatitis,
multiple sclerosis, infertility, migraines, allergies,
hemophilia, and medications for pets.
Sharps waste: According to statistics from CalRecycle, 43% of
all self-injectors throw needles in the trash. According to
CalRecycle's 2014 waste characterization study, 2014
Disposal-Facility-Based Characterization of Solid Waste in
California, the composition of California's overall disposed
waste stream is dissected by material type. There is not a
line-item for home-generated sharps, but under the category of
HHW is the subcategory "Remainder/Composite Household
Hazardous," which includes household hazardous material that, if
improperly put in the solid waste stream, may present handling
problems or other hazards, such as pesticides and caustic
cleaners, sharps, medications, and supplements. The 2014 report
estimates that remainder/composite household hazardous materials
comprises more than 94,000lbs (0.2%), of the total solid waste
stream.
Sharps risk: Improper sharps disposal can affect janitors,
housekeepers, pest control workers, groundskeepers, waste
management workers, and children or household pets among others.
Roughly 25% to 45% of all facilities processing household trash
(besides recycling) in California have workers hand-sorting
recyclable material out of that trash. A single worker's
on-the-job needle stick can mean weeks of taking drugs to
prevent the spread of infection, with side effects including
nausea, depression, and extreme fatigue as well as months
waiting for expensive periodic tests to reveal whether they
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contracted life-threatening HIV/AIDs or hepatitis B or C.
According to CalRecycle, it costs between $154 to $2,411 for
testing/treatment for a single needlestick, and around $4.6
million is spent in California every year due to needlesticks,
primarily for testing for infection and work loss while testing.
In 2013, in connection with AB 1893 (Stone and Eggman) and a
related Senate Labor Committee hearing, the Legislature
requested that the Commission on Health and Safety and Workers'
Compensation review whether provisions of current law offered
sufficient protection against sharps injuries for workers
outside healthcare occupations. As a result, the University of
California, Berkeley (UC Berkeley) released a March 2015, study,
Infection Risk from "Sharps" Injuries for Non-healthcare
Workers, which found a contrary view. That study stated, "sharps
injuries, outside the healthcare setting are uncommon. About
1-in-10,000 workers outside healthcare will experience a
needlestick in a given year. For specific industries (education,
food & hospitality, and waste management) and occupations
(custodial services and protective services), this risk is
substantially higher. However, even in these specific industries
and occupations, the risk of a sharps injury is less than 1/1000
workers/year." The study concluded that, "no evidence that
additional statutory and regulatory action covering home-health
sharps waste or sharps injuries to non-healthcare workers is
warranted."
The California Life Sciences Association asserts the results of
the UC Berkeley study can be chalked up to existing
opportunities for safe disposal, specifically stating that
"because throwing sharps in the trash is already illegal,
patients and healthcare providers have access to numerous sharps
disposal options ? Current options for disposal include
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manufacturers' and others' mail-back programs, disposal with the
patient's healthcare provider, disposal at designated household
hazardous waste facilities and some pharmacies, needle
destruction devices, and disposal via a rigid plastic container
(e.g., bleach or detergent bottle) is permitted in ten counties.
Furthermore, sharps manufacturers in California must already
include safe disposal information in the packaging inserts
accompanying the patient's medicine, maintain a call center to
answer disposal questions, and post safe disposal information on
their websites. These requirements are in addition to the
ongoing education and outreach to healthcare providers, and the
patient's primary source of information on home-health
injectable medicines is generally his or her provider."
However, the UC Berkeley study specifically looked at the
incidences of needlesticks, the cost to employers, and the cost
(if any) and risk faced by workers. Even if the incidence of
pricks, the pathogen transfer, and the cost to employers are all
low, the intent of AB 2039 is to have a safe mechanism to
prevent all injuries given the exponential growth of the
consumption of injectable drugs at home.
Sharps collection: Home-generated sharps waste is required to be
put into an approved sharps container before being transported
out to an approved drop-off location or via mail-back program.
CalRecycle maintains the Facility Information Toolbox (FacIT)
Website, which currently lists more than 600 facilities where
residents can take their home-generated sharps such as
hospitals, pharmacies, or HHW facilities.
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While disposal of sharps is illegal, there is no statutory
program in place to require the management of sharps by
manufacturers, pharmaceutical companies, pharmacies, or others.
Current law allows for a streamlined oversight structure for
those that do wish to provide a voluntary disposal for sharps to
their customers or the general public, but there is no mandate
for them to do so. Some pharmacies and health care providers
have developed programs as a way to assist their customers and
have reported some success.
Currently, out of California's 58 counties, three counties
(Tulare, San Luis Obispo, and Santa Cruz) and two cities (Galt
and Santa Cruz) have an ordinance that has some level of
requirements on retail establishments that sell sharps to accept
the used sharps for proper disposal. Other jurisdictions are
considering a similar ordinance. According to CalRecycle,
approximately 50 counties provide free disposal. At least eight
counties and some cities provide free sharps containers and one
county provides free mail-back containers to its residents as
long as supplies last.
Sharps collection requirements under the Medical Waste
Management Act (MWMA): The Department of Public Health (DPH) has
the authority to approve locations as points of consolidation
for the collection of home-generated sharps waste, which, after
collection, is transported and treated as medical waste. An
approved consolidation location is known as a "home-generated
sharps consolidation point." A home-generated sharps
consolidation point must comply with all of the following
requirements: (1) All sharps waste shall be placed in sharps
containers; and (2) sharps containers ready for disposal shall
not be held for more than seven days without the written
approval of the enforcement agency.
Under AB 2039, a home-generated sharps stewardship plan must
establish at least one home-generated sharps collection point in
every county in the state, but no less than one home-generated
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sharps collection point for every 25,000 people in each county,
and the plan must include procedures for complying with all
applicable state and federal laws and regulations for the
collection, consolidation, transportation, and recycling or
disposal of home-generated sharps waste.
Current requirements for sharps manufacturers: Pursuant to SB
486, a pharmaceutical manufacturer that sells or distributes a
medication in California that is intended to be self-injected at
home through the use of a hypodermic needle, pen needle,
intravenous needle, or any other similar device, is required to
submit a plan to CalRecycle that describes the actions taken by
the manufacturer to support or provide for the safe collection
and proper disposal of the waste devices, and educate consumers
about safe sharps management and collection opportunities. To
date, CalRecycle has received sharps collection and disposal
plans from 29 pharmaceutical manufacturers or distributors.
According to the analysis of SB 486, "?with the prohibition of
disposal of sharps in the waste stream and no convenient, cost
effect [sic] method of management identified, it is time to take
steps to find a solution of the problem. The first step to that
is to identify what the companies that manufacture the medicines
that are dispensed through a 'sharp' are doing to help their
customers address the disposal ban issue? The author's office
believes that this bill represents a first step toward
developing an EPR [Extended Producer Responsibility] approach to
the management of sharps, and provides a way to determine what
the pharmaceutical industry is doing to assist with the effort
to manage sharps."
In the opinion of the Monterey Regional Waste Management
District, the voluntary provisions of SB 486 are not working. As
of July 1, 2012, there were 31 plans submitted to CalRecycle,
which were read and graded by a 9-person evaluation team,
scoring each plan based on published consumer criteria. The
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Senate Bill 486 Evaluation Team Consumer Report Card found that,
of those 31 manufacturer reports, 20, or nearly 65% of all
submitted reports, were graded an F. In addition, 8 other
manufacturers were graded "F/Incomplete" for not submitting
plans by the legislatively mandated deadline of July 1 and being
in violation of state law.
AB 2039 proposes to repeal the provisions enacted pursuant to SB
486, entirely, and replace them with new requirements for the
collection and safe disposal of home-generated sharps.
Extended producer responsibility: CalRecycle defines extended
producer responsibility (EPR) as a strategy to place a shared
responsibility for end-of-life product management on the
producers, and all entities involved in the product chain,
instead of the general public; while encouraging product design
changes that minimize a negative impact on human health and the
environment at every stage of the product's lifecycle. This
allows the costs of treatment and disposal to be incorporated
into the total cost of a product. It places primary
responsibility on the producer, or brand owner, who makes design
and marketing decisions. It also creates a setting for markets
to emerge that truly reflect the environmental impacts of a
product, and to which producers and consumers respond.
By shifting costs and responsibilities of product disposal to
producers and others who directly benefit, EPR provides an
incentive to eliminate waste and pollution through product
design changes.
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There are a number of existing, statewide EPR programs for
various products, including, but not limited to paint, used oil,
and, most recently, mattresses.
AB 2039 proposes building on the models of the aforementioned
programs to develop EPR for home-generated medical sharps.
Related bills:
1) SB 1229 (Jackson) would provide that an entity
registered with the federal Drug Enforcement Agency to
receive a controlled substance for the purpose of
destruction is not liable for civil damages, or subject to
criminal prosecution, for maintaining a secure drug
take-back bin on its premise. This bill will be heard in
the Senate Judiciary Committee on April 12.
2) AB 1159 (Gordon, 2015) proposed establishing a pilot
product stewardship program for the management of medical
sharps and household primary batteries. It was approved by
the Assembly Environmental Safety & Toxic Materials
Committee on April 28, 2015 by a 6-0 vote. AB 1159 was held
in the Assembly Appropriations Committee.
3) AB 1893 (Stone/Eggman, 2014) proposed requiring
customers be given a free sharps disposal container with
the sale of 50 or more medical sharps for self-injection.
AB 1893 was pulled by the author from the Assembly Floor.
4) AB 403 (Stone/Eggman, 2013) proposed requiring
manufacturers that sell medical sharps to establish a
product stewardship plan for home-generated medical waste.
AB 403 was held in the Assembly Appropriations Committee.
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REGISTERED SUPPORT / OPPOSITION:
Support
California Product Stewardship Council (Sponsor)
Atlas Disposal Industries
Bay Counties Waste Services
BMS Technologies
Burrtec Waste Industries
Butte County
Cal-Waste Recovery Systems
Californians Against Waste
California Alliance for Retired Americans
California Refuse Recycling Council
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California State Association of Counties
California Teamsters Public Affairs Council Cal-Waste Recovery
Systems
City and County of San Francisco
City of Sacramento
City of Lakewood
City of Sunnyvale
Consolidated Fabricators Corp.
County of Santa Clara
CR&R Environmental Services
Davis Waste Removal Co. Inc.
Desert Valley Disposal, Inc.
Drug Policy Alliance
East Bay Counties Waste Services
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East Bay Sanitary Co.
E-Recycling of California
Garaventa Enterprises
Garden City Sanitation
GreenWaste Recovery
Inland Empire Disposal Association
Kern County
Kern Refuse, Inc.
League of California Cities
Los Angeles County Integrated Waste Management Committee/Task
Force
Los Angeles County Waste Management Association
MarBorg Industries
Marin Sanitary Service
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Monterey Regional Waste Management District
Napa Recycling & Waste Services
Northern Recycling Operations & Waste Services, LLC
Palm Springs Disposal Services
Recology
Rural County Representatives of California
San Diego County Board of Supervisors
San Francisco Public Utilities Commission
Silicon Valley Leadership Group
Solid Waste Association of North America
Solid Waste Association Orange County
South Lake Refuse & Recycling
Southern California Disposal & Recycling Stanislaus County
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Strategic Materials
Turlock Scavenger Company
United Pharmacy
Upper Valley Disposal & Recycling
Western Placer Waste Management
Authority
Varner Bros
Opposition
Advanced Medical Technology Association
Amgen
AstraZeneca
BD
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Biocom
Biotechnology Industry Organization
Biotechnology Innovation
Bristol-Myers Squibb
Cal Chamber
California Life Sciences Association
California Manufacturers and Technology Association
Industrial Environmental Association
Eli Lilly
Medtronic
Pharmaceutical Research and Manufacturers of America (PhRMA)
Silicon Valley Leadership Group
PhRMA
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Analysis Prepared by:Paige Brokaw / E.S. & T.M. / (916) 319-3965