Bill Text: CA SB727 | 2013-2014 | Regular Session | Amended
Bill Title: Medical waste: pharmaceutical product stewardship program.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Introduced - Dead) 2014-02-03 - Returned to Secretary of Senate pursuant to Joint Rule 56. [SB727 Detail]
Download: California-2013-SB727-Amended.html
BILL NUMBER: SB 727 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 3, 2013
INTRODUCED BY Senator Jackson
( Coauthor: Senator Hancock
)
FEBRUARY 22, 2013
An act to add Section 117647 to, and to add Chapter 12
(commencing with Section 118365) to Part 14 of Division 104 of, the
Health and Safety Code, relating to public health.
117670.1 to the Health and Safety Code, and to add Article 3.4
(commencing with Section 47122) to Chapter 1 of Part 7 of
Division 30 of the Public Resources Code, relating to waste
management.
LEGISLATIVE COUNSEL'S DIGEST
SB 727, as amended, Jackson. Medical waste: pharmaceutical product
stewardship program.
The existing Medical Waste Management Act,
administered by the State Department of Public Health, regulates the
management and handling of medical waste, including pharmaceutical
waste, as defined. Existing law requires, among other things, 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. Under the
law, an enforcement agency may bring an action to enjoin the
violation or threatened violation of those provisions or issue a
specified order to a person who is responsible for a violation or
threatened violation. A violation of that order, and other provisions
of law, is a crime.
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 a pharmaceutical sold in the
state to, individually or through a stewardship organization, to
submit a plan, on or before January 1, 2015, to the Department of
Resources Recycling and Recovery. The bill would require the plan to
provide for the development of a program to collect, transport, and
process home-generated pharmaceutical drugs and to include specified
aspects, including the minimum amount of collection sites, including
by January 1, 2016, at least one collection service within 10 miles
per person in the state.
The bill would require the department to post on its Internet Web
site a list of the producers or stewardship organizations that have
submitted a plan within 10 days of receipt of the plan. The bill
would provide for the review and approval of the plan by the
department, within 90 days of receipt of the plan. The bill would
require the department to post on its Internet Web site a list of
producers for which the department has approved a plan and the bill
would require the department to update this list no less than once
every 6 months.
The bill would require a producer or stewardship organization, on
or after April 1, 2016, and every 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 bill would require the producer or stewardship organization to
pay the department an annual administrative fee in an amount that is
sufficient to cover the department's costs of administering and
enforcing these provisions. The bill would require the department to
deposit the fees in the Drug Abuse Prevention and Safe Disposal
Program 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 requirement.
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 impose a
fine on a producer or stewardship organization if a stewardship plan
is not submitted by January 1, 2015. The bill would require the
department to deposit these fines and penalties into the Drug Abuse
Prevention and Safe Disposal Program Penalty Account, which this 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 enforce the bill's
requirements.
This bill would, effective January 1, 2015, prohibit a producer of
a pharmaceutical that is a cover drug, as defined, from selling or
distributing that pharmaceutical in the state unless it is included
in a product stewardship plan that is approved by the department.
This bill would require each producer to operate, individually or
jointly with other producers, an approved product stewardship program
or to enter into an agreement with a stewardship organization, as
defined, to operate that program on the producer's behalf. This bill
would require a producer, group of producers, or stewardship
organization, if applicable, to pay all associated costs with its
product stewardship program, as specified, including the costs
incurred by the state for administration and enforcement of the
program. The bill would prohibit the producer from charging specified
fees to recover the costs of its program.
This bill would require a producer, individually or jointly with
other producers, in consultation with specified entities, to develop
a product stewardship plan that includes, among other things,
certification that the product stewardship program will accept all
unwanted products, except as specified, contact information for the
individual or entity submitting the plan and for each producer
participating in the program, and a description of the methods by
which unwanted products will be collected in the state. This bill
would require the producer, group of producers, or stewardship
organization operating the program to prepare and submit a written
report to the department, as prescribed. This bill would require the
department to administer any penalties under those 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.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes no .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares the
following:
(a) The stockpiling of unused and unwanted pharmaceuticals has
increased rapidly in recent years, creating access to potentially
dangerous drugs to children and adults alike. Accidental poisoning
from ingestion of drugs among children often occurs in homes where
medicine is easily accessible. The Partnership for a Drug-Free
America released a report in February 2010 indicating that over 60
percent of teenagers are able to obtain prescription painkillers free
of charge from family and friends.
(b) Poisoning is the fastest rising cause of accidental death
among older adults, particularly from overdoses of prescription drugs
and over-the-counter medications. Unintentional poisoning of adults
over 60 years of age resulting in hospitalization increased by 43
percent in the County of Alameda from 1998 to 2006.
(c) Pharmaceutical residues have been accumulating in groundwater
and drinking water. Drugs enter the environment through multiple
sources, including flushing toilets or through leaks in landfills.
Even the most advanced wastewater treatment plants are not currently
able to account for these chemicals. The cost of developing this
waste treatment for wastewater is extremely high. Thus, many drugs
will continue to pass through wastewater treatment systems and
contaminate receiving waters unless the source of the problem is
addressed.
(d) Safe and convenient medical waste recovery programs are
critical in reducing the negative social and environmental health
impacts of improper or illegal disposal.
(e) Product stewardship programs in Canada and Europe for
hazardous wastes, medical wastes, and hard-to-handle wastes,
including electronic waste, packaging, beverage containers,
batteries, mercury-containing lamps, and other mercury-containing
products have demonstrated that shared producer responsibility
results in significant improvements in safe end-of-life management
and reductions in taxpayer and ratepayer costs.
SEC. 2. Section 117670.1 is added to the
Health and Safety Code , to read:
117670.1. "Home-generated pharmaceutical waste" means a
prescription or over-the-counter human or veterinary drug, including,
but not limited to, a drug as defined in Section 109925 or in
Section 321 (g)(1) of Title 21 of the United States Code, that is a
waste, as defined in Section 25124, derived from a household,
including, but not limited to, a multifamily residence or household.
Home-generated pharmaceutical waste may be handled through a
home-generated pharmaceutical waste stewardship plan pursuant to
Article 3.4 (commencing with Section 47122) of the Public Resources
Code.
SEC. 3. Article 3.4 (commencing with Section
47122) is added to Chapter 1 of Part 7 of Division 30 of the
Public Resources Code , to read:
Article 3.4. Drug Abuse Prevention and Safe Disposal Program
47122. The purpose of the Drug Abuse Prevention and Safe Disposal
Program established pursuant to this article is to require the
producers of pharmaceuticals to develop and implement a program to
collect, transport, and process home-generated pharmaceutical drug
waste to reduce the costs, public health risk, and environmental
impacts of the illegal and unsafe disposal of this medical waste.
47123. For purposes of this article, the following terms have the
following meanings:
(a) "Consumer" means a purchaser or owner of home-generated
pharmaceuticals, including a person, business, corporation, limited
partnership, nonprofit organization, or governmental entity.
(b) "Department" means the Department of Resources Recycling and
Recovery.
(c) "Distributor" means a person that sells or provides for free
pharmaceuticals to the general public, which may include, but is not
limited to, retailers, hospitals, veterinarians, and health clinics.
(d) "Drug abuse prevention and safe disposal plan" or "plan" means
a plan written by an individual producer, or stewardship
organization, on behalf of one or more producers.
(e) "Home-generated pharmaceutical waste" means pharmaceutical
waste as defined in Section 117670.1 of the Health and Safety Code.
(f) "Pharmaceutical" means a prescription or over-the-counter
human or veterinary drug as defined in Section 117747 of the Health
and Safety Code. For purposes of this article, "pharmaceutical"
includes any pharmaceutical that is regulated pursuant to (1) the
federal Resource Conservation and Recovery Act of 1976, as amended
(42 U.S.C. Sec. 6901 et seq.), and (2) the Radiation Control Law
(Chapter 8 (commencing with Section 114960) of Part 9). For purposes
of this article, "pharmaceutical" does not include the following
items:
(1) Vitamins or supplements.
(2) Herbal-based remedies and homeopathic drugs.
(3) Cosmetics, soap (with or without germicidal agents), laundry
detergent, bleach, household cleaning products, shampoos, sunscreens,
toothpaste, lip balm, antiperspirants, or other personal care
products that are regulated as both cosmetics and nonprescription
drugs under the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec.
301 et seq.).
(4) Drugs for which the producers provide a take-back program as
part of a federal Food and Drug Administration managed risk
evaluation and mitigation strategy (21 U.S.C. Sec. 355-1).
(5) Drugs that are biological products as defined by Section 600-3
(h) of Title 21 of the Code of Federal Regulations as it exists on
January 1, 2014 if the producer already provides a take-back program.
(6) Pet pesticide products contained in pet collars, powders,
shampoos, topical applications, or other delivery systems.
(g) "Prescription drug" means any drug that by federal or state
law may be dispensed lawfully only on prescription.
(h) (1) "Producer" shall be determined with regard to a
pharmaceutical that is sold, offered for sale, or distributed in
California as meaning one of the following:
(A) The person that manufactures a pharmaceutical and that sells,
offers for sale, or distributes that pharmaceutical in California
under that person's own name or brand.
(B) If there is no person who sells, offers for sale, or
distributes the pharmaceutical in California under the person's own
name or brand, the producer of the pharmaceutical is the owner or
licensee of a trademark or brand under which the pharmaceutical is
sold or distributed in California, whether or not the trademark is
registered.
(C) If there is no person who is a producer of the pharmaceutical
for purposes of subparagraphs (A) and (B), the producer of that
pharmaceutical is the person who brings the pharmaceutical into
California for sale or distribution.
(2) "Producer" does not include (A) a retailer that puts its store
label on a pharmaceutical or (B) a pharmacist who dispenses
prescription drugs to, or compounds a prescribed individual drug
product for a consumer.
(i) "Retailer" means a person that sells a pharmaceutical in the
state to a consumer. A sale includes, but is not limited to,
transactions conducted through sales outlets, catalogs, or the
Internet or any other similar electronic means.
(j) "Stewardship organization" means a nonprofit organization
created by the producers, including at a minimum, four
representatives one each from local government, a distributor, a
waste hauler, and a consumer health organization, to implement the
Drug Abuse Prevention and Safe Disposal Program stewardship program.
47124. A producer of any pharmaceutical sold in this state shall,
individually or through a stewardship organization, submit a drug
abuse prevention and safe disposal stewardship plan pursuant to
Section 47125 to the department to develop and implement a recovery
program to manage home-generated pharmaceutical waste in an
environmentally sound and medically safe fashion, including
collection, transportation, processing, and disposal.
47125. (a) (1) On or before January 1, 2015, a producer or the
designated stewardship organization for producers of pharmaceuticals
shall submit a stewardship plan to the department.
(2) The plan shall be posted on the producer or stewardship
organization's Internet Web site.
(b) A producer, group of producers, or stewardship organization
shall consult with stakeholders during the development of the
stewardship plan, including soliciting stakeholder comments, and
responding to stakeholder comments, and document the comments and
responses in the plan prior to submitting the stewardship plan.
(c) A stewardship plan shall include, at a minimum, all of the
following elements:
(1) Contact information for all participating producers.
(2) The number of collection services for the home-generated
pharmaceuticals subject to the plan. A baseline of the number of
home-generated pharmaceutical collection services shall be at least
one collection service within 10 miles per person in the state.
(d) The minimum number of collection sites for each plan submitted
to the department shall be as follows:
(1) On and after January 1, 2016, there shall be at least one
collection service within 10 miles per person in the state.
(2) On and after January 1, 2017, the number of collection
services shall increase 20 percent from the reported number of
collection services in 2016.
(e) On January 1, 2018, and annually thereafter, the department
shall consult with the producers and stewardship organizations, local
government, haulers, health community, and all stakeholders on how
the program is performing, and to set fair and reasonable collection
services for each year forward toward the goal of ultimately
achieving safe management of all home-generated pharmaceuticals. The
producer shall demonstrate to the department that it has achieved
maximum improvement in the collection services.
(f) A baseline of the number of home-generated pharmaceuticals
collected by all producers, or stewardship organizations, subject to
a plan, shall be calculated by weight based on the percentage of
home-generated pharmaceuticals collected during the preceding three
years.
(g) The plan shall address collecting both solid and liquid
home-generated pharmaceuticals.
(h) The methods of collection must be consistent with the
requirements of Section 47115.5. Collection shall involve the use of
two-key system whereby two individuals are needed to unlock the
disposal bin, or if a one-key system is used, whereby only one person
is needed to unlock the bin, the bin system shall render the
medication unusable.
(i) The plan shall demonstrate sufficient funding for the
stewardship program as described in the plan, including a funding
mechanism for securing and dispersing funds to cover administrative,
operational, and capital costs.
(j) The plan shall address the coordination of the stewardship
program with existing local medical waste collection programs as much
as is reasonably feasible and is mutually agreeable between those
programs.
(k) The plan shall include goals to reduce the number of
home-generated pharmaceuticals that are improperly disposed, and to
maximize the proper end-of-life management of home-generated
pharmaceuticals, including collection of home-generated
pharmaceuticals, as practical, based on current medical waste program
information.
(l) The plan shall include consumer, medical community, and
retailer education and outreach efforts to promote the collection of
home-generated pharmaceuticals. This information may include, but is
not limited to, developing, and updating as necessary, educational
and other outreach materials aimed at all distributors of
pharmaceuticals. These materials shall be made available to those
parties. These materials may include, but are not limited to, one or
more of the following:
(1) Signage that is prominently displayed and easily visible to
the consumer.
(2) 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. Written materials shall include information on
proper disposal of home-generated pharmaceuticals.
(3) Advertising or other promotional materials, or both, that
include references to home-generated pharmaceuticals collection
opportunities.
(m) Any retailer may participate, on a voluntary basis, at a
home-generated pharmaceuticals collection point pursuant to the
home-generated pharmaceuticals stewardship program.
47126. (a) The department shall post on its Internet web-site a
list of the producers or stewardship organizations that have
submitted a stewardship plan within 10 days of receipt of the plan.
(b) The department shall review the plan within 90 days of
receipt, and make a determination whether or not to approve the plan.
The department shall approve the plan if it provides for the
establishment of a home-generated pharmaceuticals stewardship program
that meets the requirements of Section 47125.
(c) (1) The approved plan shall be a public record, except that
financial, production, or sales data reported to the department by a
producer or 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 it does not
disclose financial, production, or sales data of a producer or
stewardship organization.
(d) Three months after a plan is approved, the producer or
stewardship organization shall implement the home-generated
pharmaceuticals stewardship program described in the approved plan.
(e) (1) Within five days of the department approving the plan, the
department shall post on its Internet Web site a list of producers
for which the department has approved a plan pursuant to subdivision
(b). The department shall update this posting that includes a list of
producers that are in compliance with this article no less than once
every six months thereafter.
(2) A producer that is not listed on the department's Internet Web
site pursuant to this section, but demonstrates to the satisfaction
of the department that it is in compliance with this article before
the next update of the list of compliant producers by the department,
pursuant to paragraph (1), may request a certification letter from
the department stating that the producer is in compliance. The
producer who receives the letter shall be deemed to be in compliance
with this article.
47127. (a) On or before April 1, 2016, and every year thereafter,
a producer or stewardship organization implementing a stewardship
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. The annual report shall include, but is not
limited to, all of the following elements:
(1) The number of home-generated pharmaceuticals collected by the
program in the prior year and the collection services achieved in the
prior year.
(2) A report of the total sales data for pharmaceuticals sold to
distributors in the state for the previous calendar year.
(3) A report on the feedback from a stakeholders' meeting, hosted
by producers or the stewardship organization, that was made available
by Web cast, prior to submittal of the annual report.
(4) Independently audited financial statements that detail the
financing method selected to sustainably fund the implementation of
the plan to achieve the identified collection services described in
the plan, pursuant to Section 47125.
(5) A description of methods used to collect, transport, and
process home-generated pharmaceuticals in this state.
(6) A description of how solid and liquid home-generated
pharmaceuticals are collected.
(7) A description of how pharmaceuticals regulated pursuant to the
Resource Conservation and Recovery Act of 1976, as amended (42
U.S.C. Sec. 6901 et seq.), and the Radiation Control Law (Chapter 8
(commencing with Section 114960) of Part 9 of the Health and Safety
Code) are collected.
(8) Locations, hours, and contact information for all California
collection points set up by the producers covered by the plan.
(9) Examples and descriptions of educational materials distributed
to various stakeholders aimed to increase collection.
(10) An evaluation of the effectiveness of the program specific to
collection, public awareness, convenience, and reduced improper
disposal by both legal and illegal drug use.
(11) Any programmatic changes the producer, the stewardship
organization, or both recommend based on new data provided in the
annual report.
(b) The department shall review an annual report by doing all of
the following:
(1) For the reports submitted for the 2016 calendar year, and each
year thereafter, producers and stewardship organizations shall
certify the accuracy of the collection points listed in the annual
report and that they are located in every county in the state and
established at a minimum of one site per 5,000 people.
(2) Reviewing sales data and collection numbers provided for the
state to verify collection services.
(3) If a collection service pursuant to Section 47125 is not
achieved, the department shall direct the producer or the stewardship
organization to determine the most effective way to improve
collection services.
(4) Verifying that all annual report elements specified in
subdivision (a) have been addressed in the report.
(c) If the department does not act on a report within 45 days of
receipt, the report shall be approved.
(d) The department shall make all reports submitted pursuant to
this section available to the public on the department's Internet Web
site.
(e) If the collection service for the home-generated
pharmaceuticals subject to the plan meets the collection service,
specified in Section 47125, or if the producer or stewardship
organization demonstrates compliance with this article that is
consistently and significantly above mandated performance levels, the
department may reduce the frequency of reporting pursuant to this
section.
(f) The department shall review the annual report required
pursuant to this section and, within 90 days of receipt, shall adopt
a finding of compliance or noncompliance with this article.
47128. (a) The department shall enforce this chapter.
(b) (1) The producer or stewardship organization shall pay the
department an annual administrative fee pursuant to paragraph (2).
(2) The department shall impose fees in an amount that is
sufficient to cover the department's full costs of administering and
enforcing this chapter, including any program development costs or
regulatory costs incurred by the department prior to the submittal of
the stewardship plans. Fee revenues collected pursuant to this
section shall only be used to administer and enforce this article.
The total fee revenue collected shall not exceed $500,000 per year.
(3) The department shall deposit all fees collected pursuant to
this subdivision into the Drug Abuse Prevention and Safe Disposal
Program Account, which is hereby created in the Integrated Waste
Management Fund. Upon appropriation by the Legislature, moneys
deposited into the account may be expended by the department to
administer and enforce this article.
(c) (1) A civil penalty may be administratively imposed by the
department on any person who violates this article in an amount of up
to one thousand dollars ($1,000) per violation per day.
(2) A person who intentionally, knowingly, or negligently violates
this article may be assessed a civil penalty by the department of up
to ten thousand dollars ($10,000) per violation per day.
(A) In assessing any fine and penalty, the department shall
consider any exigent circumstance that contributed to the stewardship
organization or individual producer not meeting the required
recovery targets.
(B) The department may require the producer or stewardship
organization to increase expenditure on program compliance in lieu of
part of any fine or penalty to be imposed for not meeting the
required recovery targets.
(d) (1) The department shall impose a fine on a producer or
stewardship organization if a stewardship plan required pursuant to
Section 47125 is not submitted by January 1, 2015.
(2) The fine in paragraph (1) shall be effective on the 120th day
after the list described in Section 47126 is posted on the department'
s Internet Web site, and shall apply to any producer that is not
listed on the department's Internet Web site, and shall remain in
effect until the producer is listed on the department's Internet Web
site or can demonstrate compliance with the requirements of Section
47125. A two-thousand-five-hundred-dollar ($2,500) fine will be
imposed on the first day, and will increase by 50 percent with
interest each day thereafter until a plan is submitted.
(e) The department shall deposit all fines and penalties collected
pursuant to subdivisions (c) and (d) into the Drug Abuse Prevention
and Safe Disposal Program Penalty Account, which is hereby created in
the Integrated Waste Management Fund. Upon appropriation by the
Legislature, moneys deposited into the account may be expended by the
department to enforce this article.
47129. (a) Except as provided in subdivision (c), an action
solely to increase the collection of home-generated pharmaceuticals
by a producer, stewardship organization, or retailer that affects the
types or quantities being recycled, or the cost and structure of any
return program, 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 pharmaceuticals, except for
the home-generated pharmaceuticals stewardship assessment, or the
output or production of home-generated pharmaceuticals, or any
agreement restricting the geographic area or customers to which
home-generated pharmaceuticals will be sold.
SECTION 1. Section 117647 is added to the
Health and Safety Code, to read:
117647. (a) "Covered drugs" means all drugs as defined in Section
201 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
321(g)(1)), and covered under Section 503 of the act (21 U.S.C.
Section 353(b)(1)), including both brand name and generic drugs.
(b) Covered drugs do not include any of the following:
(1) Vitamins or supplements.
(2) Herbal-based remedies, or homeopathic drugs, products, or
remedies.
(3) Cosmetics, soap, with or without germicidal agents, laundry
detergent, bleach, household cleaning products, shampoo, sunscreen,
toothpaste, lip balm, antiperspirants, or other personal care
products that are regulated as both cosmetics and nonprescription
drugs under the FFDCA.
(4) Drugs for which a producer provides a take-back program
as part of an FFDCA managed risk evaluation and mitigation strategy.
(5) Drugs that are biological products, as defined in Section 262
(i) of Title 42 of the United States Code, if the producer already
provides a take-back program
(6) Pet pesticide products contained in pet collars, powders,
shampoos, topical applications, or other delivery systems.
(7) Nonprescription drugs.
SEC. 2. Chapter 12 (commencing with Section
118365) is added to Part 14 of Division 104 of the Health and Safety
Code, to read:
CHAPTER 12. PHARMACEUTICAL PRODUCT STEWARDSHIP PROGRAM
118365. For purposes of this chapter, "stewardship organization"
means a nonprofit organization created by a producer to implement the
pharmaceutical product stewardship program described in Section
118365.1.
118365.1. (a) Effective January 1, 2015, a producer of a
pharmaceutical that is a covered drug shall not sell or distribute
that pharmaceutical in the state unless it is included in a product
stewardship plan approved by the department.
(b) Each producer shall do one of the following:
(1) Operate, individually or jointly with other producers, a
product stewardship program approved by the department.
(2) Enter into an agreement with a stewardship organization to
operate, on the producer's behalf, a product stewardship program
approved by the department.
(c) (1) A producer, group of producers, or stewardship
organization shall pay all administrative and operational fees
associated with its product stewardship program, including the costs
of collecting, transporting, and disposing of unwanted products
collected from residential generators and the recycling or disposal,
or both, of packaging collected with the unwanted product.
(2) A producer, group of producers, or stewardship organization
shall pay for all fees associated with obtaining compliance with the
California Environmental Quality Act (Division 13 (commencing with
Section 21000) of the Public Resources Code), if required, for a
product stewardship program and product stewardship plan.
(3) A person or producer shall not charge a specific point-of-sale
fee to a consumer to recover the costs of its product stewardship
program, and shall not charge a specific point-of-collection fee at
the time the unwanted products are collected from residential
generators or delivered for disposal.
(4) A producer, group of producers, or stewardship organization
shall pay all costs incurred by the state, including, but not limited
to, the department's costs, for the administration and enforcement
of its pharmaceutical product stewardship program. Exclusive of any
fines, the state shall only recover the actual costs of
administration and enforcement under this chapter, and shall not
charge any amounts under this chapter in excess of the actual
administrative and enforcement costs.
118365.2. In consultation with local governments, water
districts, sanitation districts, pharmacies, waste haulers,
environmental health officers, and all interested stakeholders, the
producers, individually or jointly with other producers, shall
develop a product stewardship plan.
(a) Each product stewardship plan required under Section 118365.1
shall contain all of the following:
(1) Certification that the product stewardship program will accept
all unwanted products, regardless of who produced them under a joint
plan, unless excused from this requirement by the department as part
of its approval of the plan.
(2) Contact information for the individual and the entity
submitting the plan and for each of the producers participating in
the product stewardship program.
(3) A description of the methods by which unwanted products from
residential generators will be collected in the state and an
explanation of how the collection system will be convenient and
adequate to serve the needs of all California residents.
(4) A description of how the product stewardship plan will provide
collection services for unwanted products in all areas of California
that are convenient to the public and adequate to meet the needs of
the population in the area being served.
(5) If applicable, the location of each collection site and
locations where envelopes for a mail-back program are available.
(6) A list containing the name, location, permit status, and
record of any penalties, violations, or regulatory orders received in
the previous five years by each person that will be involved in
transporting unwanted products and each medical waste or hazardous
disposal facility proposed to participate in the product stewardship
program.
(7) A description of how the unwanted products will be safely and
securely tracked and handled from collection through final disposal,
and the policies and procedures to be followed to ensure security and
adherence to highest management standards.
(8) A description of public education and outreach activities that
are consistent with this chapter, and how the effectiveness of those
programs and activities will be evaluated.
(9) A description of how the scope and extent of the product
stewardship program is reasonably related to the amount of covered
drugs that are sold in the state by the producer, or group of
producers.
(10) A starting date for the collection of unwanted products.
(11) If applicable, a description of how support will be provided
to any law enforcement agencies within the state that operate, or
later agree to operate, a collection program for controlled
substances, including the provision of a collection kiosk with
appropriate accessories and signage, the ability to accept controlled
substances and other covered drugs, and technical support, up to and
including an appropriate person to provide on-site assistance with
the sorting and separation of controlled substances at no cost to a
participating law enforcement agency. Otherwise, controlled
substances are expressly excluded from this chapter, notwithstanding
any other provision.
(12) A description of how collection sites for unwanted products
may be placed at appropriate retail stores in the state, including a
description of the involvement of the retail store. Retailers are not
required or mandated to host collection sites, and nothing in this
chapter shall be interpreted as requiring that participation.
(13) If more than one producer will be involved in a proposed
product stewardship program, the plan for that program shall include
a fair and reasonable manner for allocating the costs of the program
among the participants in that program, so that the portion of costs
paid by each producer is reasonably related to the amount of covered
drugs that producer sells in the state.
118365.3. On or before January 1, 2016, or at a later date as
approved in writing by the department, and in each subsequent year,
each producer, group of producers, or stewardship organization
operating a product stewardship program shall prepare and submit to
the department an annual written report describing the program's
activities during the previous reporting period.
118365.4. The department shall administer the penalty provisions
for this chapter.
SEC. 3. 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.
