Amended in Assembly April 8, 2013

Amended in Assembly March 19, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 403

Introduced by Assembly Members Stone and Eggman

February 15, 2013

An act to amend Section 118286 of the Health and Safety Code, and to repeal and add Article 3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of Division 30 of the Public Resources Code, relating to solid waste.

LEGISLATIVE COUNSEL’S DIGEST

AB 403, as amended, Stone. Solid waste: home-generated sharps.

(1) Existing law requires a pharmaceutical manufacturer selling or distributing medication that is intended to be self-injected at home to submit, on an annual basis, to the Department of Resources Recycling and Recovery a plan supporting the safe collection and proper disposal of specified waste devices.

This bill would require a producer of home-generated sharps or a stewardship organization designated by the producer to submit a home-generated sharps stewardship plan by April 1, 2015, to the Department of Resources Recycling and Recovery. The bill would require 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, and to include specified elements, including provisions to meet unspecified minimum collection rates for the home-generated sharps subject to the plan.

The bill would provide for the review and approval of the plan by the department and would require the department, on January 1, 2016, or upon the date the first plan is approved, whichever is earlier, to post on its Internet Web site a list of producers for which the department has approved a plan. The bill would require a wholesaler, health care facility, retailer, or other distributor that distributes or sells home-generated sharps to monitor the department’s Internet Web site to determine if the sale of a producer’s home-generated sharps is in compliance with the bill. The bill would, as of 120 days after that posting, prohibit a producer or retailer from selling or offering for sale in this state home-generated sharps to a person in this state unless the producer of those home-generated sharps is in compliance with the bill’s requirements.

The bill would require a producer or stewardship organization, by April 1, 2017, and every subsequent year thereafter, to prepare and submit to the department an annual report describing the activities carried out pursuant to the plan during the previous calendar year. The department would be required to review the report and would direct the department, if the annual report does not demonstrate the achievement of an unspecified collection rate increase, to require the program to take additional actions with regard to improving and increasing the number of home-generated sharps collection points, ensuring accessibility to those points, and providing additional education and outreach activities. The bill would authorize the department to exempt a producer or stewardship organization from the annual report requirements if the department determines that the collection rate for the home-generated sharps subject to a plan meets a 95% collection rate.

The bill would require a producer or stewardship organization submitting a plan to the department to pay the department an annual administrative fee in an amount that is sufficient to cover the department’s full costs of administering and enforcing these provisions. The bill would require the department to deposit the fees in the Safe Sharps Disposal Account, which the bill would establish in the Integrated Waste Management Fund, and the department would be authorized to expend the moneys in that account, upon appropriation by the Legislature, to administer and enforce the bill’s requirements.

The bill would require the department to enforce these provisions and would authorize the department to impose an administrative civil penalty on a person who violates the bill’s requirements or on a producer or stewardship organization that does not achieve the unspecified minimum collection rate. The department would be required to deposit all penalties collected into the Safe Sharps Disposal Penalty Account, which the bill would create in the Integrated Waste Management Fund, and the department would be authorized to expend the moneys in that account, upon appropriation by the Legislature, to enforce the bill’s requirements.

begin delete

The bill would also allow a producer who is subject to an approved plan and in compliance with the bill to bring a civil action to recover costs, damages, and fees from another producer for failure to comply with the bill’s provisions.

end delete

(2) The existing Medical Waste Management Act, administered by the State Department of Public Health, prohibits a person from knowingly placing home-generated sharps waste in certain types of containers, requires that home-generated sharps waste be transported only in a sharps container, as defined in the act, or other container approved by the department or local enforcement agency, and requires that this waste be managed only at specified locations.

This bill would additionally allow home-generated sharps waste to be managed at a facility or collection point operated pursuant to an approved home-generated sharps stewardship plan.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert begin insert

The Legislature finds and declares all of the
following:

end insert begin insert

(a) The United States Environmental Protection Agency
estimates that about 9 million people in the United States currently
use disposable needles (sharps) at home to deliver medications to
treat a variety of diseases and conditions, including diabetes,
cancer, multiple sclerosis, migraines, and allergies. United States
households use more than 3 billion disposable needles and syringes
each year.

end insert begin insert

(b) Since 2008 it has been illegal in California for individuals
to throw away home-generated sharps. While the state banned
needles from trash disposal in 2008, there is still no consistent,
statewide program that is sustainably funded or has high levels
of effectiveness at collecting the majority of sharps disposed of
each year in California. As a result, thousands of pounds of
illegally disposed of sharps enter the municipal waste stream each
year, putting many people at risk of injury or infection.

end insert begin insert

(c) Sharps in the trash pose serious health risks to sanitation
workers, water treatment facility operators, and the general public.
In addition to the immediate risk of a needle stick injury, sharps
put individuals at risk of acquiring blood borne infectious diseases,
such as hepatitis or HIV. Individuals who suffer a needle stick
injury must receive immediate treatment and followup care,
including multiple lab tests and medications.

end insert begin insert

(d) When sanitation workers encounter sharps, productivity
suffers and costs increase. When workers sustain a needle stick
injury, the costs of care are borne by the waste management
company, the workers’ compensation insurer, and ultimately,
taxpayers and ratepayers.

end insert begin insert

(e) It is the intent of the Legislature, in enacting the safe
home-generated sharps recovery program, as established by Article
3.3 (commencing with Section 47115) of Chapter 1 of Part 7 of
Division 30 of the Public Resources Code, to ensure affordable
and convenient sharps collection opportunities, which, in turn,
will help prevent the improper management of those sharps.

end insert

begin delete SECTION 1. end delete
begin insert SEC. 2. end insert   

Section 118286 of the Health and Safety Code is
amended to read:

118286.  

(a) A person shall not knowingly place
home-generated sharps waste in any of the following containers:

(1) Any container used for the collection of solid waste,
recyclable materials, or greenwaste.

(2) Any container used for the commercial collection of solid
waste or recyclable materials from business establishments.

(3) Any roll-off container used for the collection of solid waste,
construction, and demolition debris, greenwaste, or other recyclable
materials.

(b) Home-generated sharps waste shall be transported only in
a sharps container, or other containers approved by the enforcement
agency, and shall only be managed at any of the following:

(1) A household hazardous waste facility pursuant to Section
25218.13.

(2) A “home-generated sharps consolidation point” as defined
in subdivision (b) of Section 117904.

(3) A medical waste generator’s facility pursuant to Section
118147.

(4) A facility through the use of a medical waste mail-back
container approved by the department pursuant to subdivision (b)
of Section 118245.

(5) A facility or other home-generated sharps collection point
operated pursuant to a home-generated sharps stewardship plan
approved pursuant to Article 3.3 (commencing with Section 47115)
of Chapter 1 of Part 7 of Division 30 of the Public Resources Code.

begin delete SEC. 2. end delete
begin insert SEC. 3. end insert   

Article 3.3 (commencing with Section 47115) of
Chapter 1 of Part 7 of Division 30 of the Public Resources Code
is repealed.

begin delete SEC. 3. end delete
begin insert SEC. 4. end insert   

Article 3.3 (commencing with Section 47115) is added
to Chapter 1 of Part 7 of Division 30 of the Public Resources Code,
to read:

 

Article 3.3.  Safe Home-Generated Sharps Recovery Program

 

47115.  

The Legislature finds and declares that the purpose of
the safe home-generated sharps recovery program established by
this article is to require the producers of injection devices to
develop and implement a program to collect, transport, and process
home-generated sharps, thereby reducing the costs, public health
risks, and environmental impacts of the illegal and unsafe disposal
of home-generated sharps in this state.

47116.  

For purposes of this article, the following terms have
the following meanings:

(a) “Consumer” means a person that purchases or owns
home-generated sharps.

(b) “Distributor” means a person that sells sharps or provides
sharps for free to the general public for home use, which may
include, but is not limited to, a retailer, a veterinarian, or a health
clinic, health dispensary, or health facility licensed under Division
2 (commencing with Section 1200) of the Health and Safety Code.

(c) “Home-generated sharps” means hypodermic needles,
syringes with needles attached, pen needles, intravenous needles,
or any other similar device intended to self-inject medication at
home.

(d) “Program” means the program implementing an approved
home-generated sharps stewardship plan.

(e) “Retailer” means a person that sells home-generated sharps
in the state to a consumer. A sale includes, but is not limited to, a
transaction conducted through sales outlets, catalogs, or the Internet
or any other similar electronic means.

(f) “Stewardship organization” means a nonprofit organization
created by one or more producers that also includes at least four
additional members, who shall be representatives from each of the
following entities, but not more than one representative per entity,
to the extent that the other entities do not have a representative:

(1) A local government.

(2) A distributor.

(3) A solid waste hauler.

(4) A consumer health organization that will implement the
home-generated sharps stewardship plan.

(g) “Home-generated sharps stewardship plan” or “plan” means
a plan submitted by an individual producer or by a stewardship
organization on behalf of one or more producers.

(h) “Producer” means, with regard to home-generated sharps
that are sold, offered for sale, or distributed in the state, one of the
following:

(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 sells, offers for sale, or distributes
home-generated sharps in the state under the person’s own name
or brand, the producer of the home-generated sharps 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.

(3) If there is no person who is a producer of the sharps for
purposes of paragraphs (1) and (2), the producer of those sharps
is the person who imports the home-generated sharps into the state
for sale or distribution.

(i) “Stakeholder” means a person that is subject to, or will
participate in, the program that will be implemented by a proposed
home-generated sharps stewardship plan, including, but not limited
to, consumers, retailers, distributors, and health care providers and
facilities.

47117.  

(a) A producer or retailer shall not sell or offer for sale
in this state home-generated sharps to a person in this state unless
the producer of those home-generated sharps is in compliance with
this article.

(b) The sales prohibition specified in subdivision (a) shall apply
no earlier than 120 days after the date that the department posts
on its Internet Web site a list of producers for which the department
has approved a plan pursuant to paragraph (1) of subdivision (a)
of Section 47121.

(c) The sales prohibition specified in subdivision (a) shall apply
until the producer of the home-generated sharps is listed as
compliant on the department’s Internet Web site or demonstrates
compliance pursuant to subdivision (b) of Section 47122.

47118.  

(a) On or before April 1, 2015, a producer or a
stewardship organization designated by the producer shall submit
a home-generated sharps stewardship plan to the department. The
home-generated sharps stewardship plan shall also be posted on
the Internet Web site of the producer or stewardship organization.
The plan shall provide for the implementation of the plan for each
calendar year, commencing January 1, 2016.

(b) The producer, group of producers, or stewardship
organization shall consult with stakeholders during the
development of the home-generated sharps stewardship plan,
including soliciting stakeholder comments and responding to
stakeholder comments, and shall document those comments in the
plan.

(c) The home-generated sharps stewardship plan shall provide
for the development and implementation of a recovery program
to reduce the generation of, and manage the begin delete end-of-life end delete begin insert end of life end insert
of, home-generated sharps, in an environmentally sound and
medically safe manner, including collecting, transporting,
processing, and disposing. The plan shall include, at a minimum,
all of the following elements:

(1) Contact information for all participating producers.

(2) Procedures for calculating the collection rate for the
home-generated sharps subject to the plan, which shall be
determined using, as a baseline, the number of home-generated
sharps collected by all producers subject to the plan, by weight,
during the 2014 calendar year, as compared to the average number
of home-generated sharps that are sold in the state during the 2013
calendar year by producers that are subject to the plan.

(3) Provisions to meet the minimum collection rate for the
home-generated sharps subject to the plan, which shall be
determined in the following manner:

(A) On and after January 1, 2016, the minimum collection rate
shall be _____ percent of the average number of home-generated
sharps that are sold in the state during the previous three calendar
years by the producers who are subject to the plan.

(B) On and after January 1, 2017, the minimum collection rate
shall be _____ percent of the average number of home-generated
sharps that are sold in the state during the previous three calendar
years by the producers who are subject to the plan.

(C) On and after January 1, 2018, and annually thereafter, the
collection rate shall be determined pursuant to Section 47120.

(4) (A) A demonstration of sufficient funding for the
home-generated sharps stewardship program proposed by the plan,
including a funding mechanism for securing and dispersing funds
to cover administrative, operational, and capital costs.

(B) The plan shall require the producer, and not consumers, to
be responsible for implementing the home-generated sharps
stewardship program.

(C) The plan shall require that any surplus funds provided to
implement the home-generated sharps stewardship program be
used only to implement the program.

(5) Coordinate the home-generated sharps stewardship program
with existing local medical waste collection programs, to the extent
this requirement is reasonably feasible and mutually agreeable by
those programs.

(6) Programs to reduce the number of postconsumer sharps that
are illegally disposed of, and to maximize the proper end-of-life
management of home-generated sharps, including the collection
of home-generated sharps, as practical, based on current medical
waste program information.

(7) Education and outreach efforts for consumers, the medical
community, and retailers that would promote the collection of
home-generated sharps. This information may include, but is not
limited to, developing, and updating as necessary, educational and
other outreach materials aimed at all retailers and distributors of
home-generated sharps. These materials shall be made available
to those parties and may include, but are not limited to, one or
more of the following:

(A) Signage that is prominently displayed and easily visible to
the consumer.

(B) Written materials and templates of materials for reproduction
by retailers to be provided to the consumer at the time of purchase
or delivery, or both. These written materials shall include
information on the prohibition of the improper disposal of
home-generated sharps.

(C) Advertising or other promotional materials, or both, that
include references to home-generated sharps collection
opportunities and the prohibition on the improper disposal of
home-generated sharps.

(8) Methods for demonstrating to the department that the
program implemented pursuant to the plan achieves the maximum
improvement possible in achieving the minimum collection rate.

(9) 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 5,000 people in
the state.

47119.  

A retailer may voluntarily participate as a
home-generated sharps collection point pursuant to the
home-generated sharps stewardship program.

47120.  

On or before January 1, 2018, the department shall
consult with producers, stewardship organizations, local
government, solid waste haulers, the health community, and all
other stakeholders regarding the program performance. The
department shall set a fair and reasonable minimum collection rate
for the 2018 calendar year and for each subsequent calendar year
to achieve the goal of safely managing all home-generated sharps
in this state.

47121.  

(a) The department shall review a home-generated
sharps stewardship plan submitted pursuant to Section 47118 within
90 days of receipt. The department shall approve the plan if the
department determines the plan provides for the establishment of
a home-generated sharps stewardship program that meets the
requirements of Section 47118. If the department does not approve
the plan, the department shall allow the producer or stewardship
organization to resubmit the plan within 90 days after receiving
notice of disapproval from the department.

(b) (1) The approved plan shall be a public record, except that
financial, production, or sales data reported to the department by
a producer or by the stewardship organization is not a public record
under the California Public Records Act (Chapter 3.5 (commencing
with Section 6250) of Division 7 of Title 1 of the Government
Code) and shall not be open to public inspection.

(2) Notwithstanding paragraph (1), the department may release
a summary form of financial, production, or sales data if the
department does not disclose financial, production, or sales data
of a producer or stewardship organization.

(c) On or before_____ , or three months after a plan is approved
pursuant to subdivision (a), whichever is later, but no later than
January 1, 2016, the producer or stewardship organization shall
implement the home-generated sharps stewardship program
described in the approved plan.

47122.  

(a) (1) On January 1, 2016, or upon the date the first
plan is approved, whichever is earlier, the department shall post
on its Internet Web site a list of producers for which the department
has approved a plan pursuant to subdivision (a) of Section 42121.
The department shall update this posting no less than once every
six months thereafter.

(2) On and after July 1, 2016, the department shall post a notice
on its Internet Web site listing producers that are in compliance
with this article and shall update this posting no less than once
every six months.

(b) A producer that is not listed on the department’s Internet
Web site pursuant to this section, but that demonstrates to the
satisfaction of the department that it is in compliance with this
chapter before the next notice is required to be posted pursuant to
this section, may request a certification letter from the department
stating that the producer is in compliance. The producer who
receives that letter shall be deemed to be in compliance with this
chapter.

(c) A wholesaler, health facility, as defined in Section 1250 of
the Health and Safety Code, retailer, or other distributor that
distributes or sells home-generated sharps shall monitor the
department’s Internet Web site to determine if the sale of a
producer’s home-generated sharps is in compliance with this
chapter.

47123.  

On or before April 1, 2017, and every subsequent year
thereafter, each producer or sharps stewardship organization
implementing a plan shall prepare and submit to the department
an annual report describing the activities carried out pursuant to
the plan during the previous calendar year, commencing with the
2016 calendar year. The annual report shall include, but is not
limited to, all of the following elements:

(a) The number of home-generated sharps collected by the
program in the previous calendar year and the collection rate
achieved in the previous calendar year.

(b) A report of the total sales data for sharps sold to distributors
in the state for the previous calendar year.

(c) A report on the feedback from a stakeholders’ meeting, that
shall be hosted by the producers subject to the plan and made
available by Webcast, prior to submittal of the annual report.

(d) Independently audited financial statements that detail the
financing method selected to sustainably fund the implementation
of the plan to achieve the minimum collection rates described in
the plan, pursuant to paragraph (3) of subdivision (c) of Section
47118.

(e) Examples and descriptions of educational materials
distributed to various stakeholders aimed at increasing collection.

(f) An evaluation of the effectiveness of the program specific
to collection, public awareness, convenience, and reduced improper
disposal associated with both legal and illegal drug use.

(g) Any programmatic changes the producer or the stewardship
organization recommends based on new data provided in the report.

(h) The location, hours, and contact information for all
home-generated sharps collection points established pursuant to
the plan, including a certification that this information is accurate,
that a home-generated sharps collection point has been established
in every county in the state, and that the number of home-generated
sharps collection points is equal to at least one for every 5,000
people in the state.

47124.  

(a) The department shall review the annual report
submitted pursuant to Section 47123, including reviewing the
accuracy of the list of home-generated sharps collection points
that are certified to be established pursuant to the plan, and the
data used to determine the collection rate, including sales and
collection data. The department shall also determine whether all
of the elements specified in begin delete subdivision end delete begin insert subdivisions end insert (a) to (h),
inclusive, of Section 47123 are included in the report.

(b) If the annual report does not demonstrate that the program
has achieved a collection rate increase of ___ percent, the
department may require the program to take additional actions
with regard to improving and increasing the number of
home-generated sharps collection points, ensuring accessibility to
those points, and providing additional education and outreach
activities.

(c) If the department does not disapprove a report within 45
days of receipt, the report shall be deemed approved by the
department.

(d) The department shall make all reports submitted to the
department pursuant to this section available to the public on the
department’s Internet Web site.

47125.  

If the department determines that the collection rate for
the home-generated sharps subject to a plan meets 95 percent, the
department may exempt a producer or stewardship organization
from any or all of the elements required to be included in the annual
report specified in Section 47123.

47126.  

(a) A producer or stewardship organization submitting
a plan to the department shall pay the department an annual
administrative fee pursuant to subdivision (b).

(b) The department shall impose the annual fee in an amount
that is sufficient to cover the department’s full costs of
administering and enforcing this article, including any program
development costs or regulatory costs incurred by the department
prior to the submittal of the plan. The department shall deposit the
fees in the Safe Sharps Disposal Account, which is hereby
established in the Integrated Waste Management Fund. The
department may expend the moneys in the Safe Sharps Disposal
Account, upon appropriation by the Legislature, to administer and
enforce this article.

47127.  

(a) The department shall enforce this article and may
impose an administrative civil penalty on a person who violates
this article in an amount of up to one thousand dollars ($1,000)
per violation per day.

(b) The department may impose an administrative civil penalty
on a person who intentionally, knowingly, or negligently violates
this article in an amount of up to ten thousand dollars ($10,000)
per violation per day.

(c) (1) The department may impose the civil penalty specified
in subdivision (a) or (b) on a producer or stewardship organization
for which the annual report submitted does not demonstrate that
the ____ begin insert percent end insert minimum collection rate has been achieved. In
lieu of imposing a civil penalty, the department may require a
producer or stewardship organization to take additional actions to
comply with this article.

(2) In assessing a penalty pursuant to this subdivision on a
producer or stewardship organization, the department shall consider
any exigent circumstance that contributed to the producer or
stewardship organization not meeting the required minimum
collection rate.

(d) The department shall deposit all penalties collected pursuant
to this section into the Safe Sharps Disposal Penalty Account,
which is hereby created in the Integrated Waste Management Fund.
Upon appropriation by the Legislature, moneys deposited into the
Safe Sharps Disposal Penalty Account may be expended by the
department to enforce this article.

begin delete

47128.  

(a) A producer who is subject to an approved plan and
in compliance with this article may bring a civil action to recover
costs, damages, and fees, as specified in subdivision (c), from
another producer for failure to comply with this article.

(b) An action under this section may be brought against one or
more producers who is not in compliance with this article, except
an action shall not be commenced under either of the following
circumstances:

(1) No earlier than 60 days after a written notice of the
producer’s intention to file an action has been provided to the
department and to the producer who is alleged to be noncompliant.

(2) If the department has commenced an enforcement action
against the producer who is alleged to be noncompliant and is
diligently pursuing that action.

(c) In an action under this section, the plaintiff may recover
from a producer who has been found to be noncompliant all of the
following:

(1) The costs the plaintiff incurred in collecting, handling,
recycling, or properly disposing of home-generated sharps
reasonably identified as having originated from the noncompliant
producer.

(2) An amount of damages equal to no more than three times
those costs specified in paragraph (1).

(3) The plaintiff’s attorney’s fees and costs of bringing the
action.

(d) An action to recover the costs specified in this section may
be brought in any court in the state, without regard to the amount
in dispute.

end delete

47129.  

(a) Except as provided in subdivision (c), an action
solely to increase the collection of home-generated sharps by a
producer, stewardship organization, or retailer that affects the types
or quantities being collected, or the cost and structure of any
program implementing a stewardship plan, is not a violation of
the statutes specified in subdivision (b).

(b) The following statutes are not violated by an action specified
in subdivision (a):

(1) The Cartwright Act (Chapter 2 (commencing with Section
16700) of Part 2 of Division 7 of the Business and Professions
Code).

(2) The Unfair Practices Act (Chapter 4 (commencing with
Section 17000) of Part 2 of Division 7 of the Business and
Professions Code).

(c) Subdivision (a) shall not apply to any agreement establishing
or affecting the price of home-generated sharps or the output or
production of home-generated sharps, or any agreement restricting
the geographic area or customers to which home-generated sharps
will be sold.