[HISTORY: Adopted by the City Commission
of the City of Parsons 3-20-2023 by Ord. No. 6532. Amendments noted where
applicable.]
The purpose of this chapter is to protect the health, safety,
and welfare of the public and of the environment by providing for
the safe and orderly disposal of drug waste; and by placing responsibility
for end-of-life management of drug products on the manufacturers and/or
producers of the products, while encouraging product design that minimizes
negative impacts on human health and the environment at every stage
of the product's life cycle.
This chapter may be cited as the "City of Parsons, Kansas, Safe
Drug Disposal Ordinance."
For the purposes of this chapter, the following terms have the
meanings given below:
The City of Parsons, Kansas.
Refers to the City of Parsons City Commission.
Residents of single- and multiple-family residences or other
locations who possess, dispose of, and/or abandon household drugs.
"Consumer generators" does not include airport security, drug seizures
by law enforcement, pharmacy waste, business waste, or any other source
identified by the Department as a nonconsumer source.
For purposes of this chapter shall mean any substance listed
under 21 U.S.C. §§ 812 and 813 or any successor legislation.
The County of Labette.
All drugs, including both brand name drugs and generic drugs,
and prescription drugs and nonprescription drugs. Notwithstanding
the foregoing sentence, "covered drug" does not include: a) herbal-based
remedies and homeopathic drugs, products, or remedies; b) 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 ("FFDCA") [21 U.S.C. § 301 et seq.
(2002)]; c) drugs for which 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. § 355-1); d) drugs that
are biological products as defined by 21 CFR 600.3(h) as it exists
on the effective date of this chapter if the producer already provides
a take-back program; and e) pet pesticide products contained in pet
collars, powders, shampoos, topical applications, or other delivery
systems.
The City of Parsons Police Department.
The City of Parsons Police Chief or his or her designee.
A person that sells or distributes drugs and covered drugs
for resale to an entity other than a consumer.
A) Articles recognized in the official United States Pharmacopeia,
the official National Formulary, the official Homeopathic Pharmacopoeia
of the United States, or any supplement to any of them; b) articles
intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or other animals; c) articles, other
than food, intended to affect the structure or any function of the
body of humans or other animals; and d) articles intended for use
as a component of any article specified in clause a), b), or c) of
this definition. Notwithstanding the foregoing sentence, "drugs" does
not include or mean medical devices or their component parts or accessories.
A person other than an individual.
A drug that is chemically identical or bioequivalent to a
brand name drug in dosage form, safety, strength, route of administration,
quality, performance characteristics, and intended use, though inactive
ingredients may vary.
A "hazardous waste" as defined in the Federal Resource Conservation
and Recovery Act (RCRA) of 1976, as amended (42 U.S.C.A. § 6901
et seq.) and the implementing regulations (40 CFR Parts 239 through
282), as amended. This waste includes, but is not limited to, bulk
chemotherapy drugs, P-listed waste, U-listed waste and characteristic
hazardous waste.
A system whereby consumer generators of unwanted products
obtain prepaid and pre-addressed mailing envelopes in which there
is a bottle to place unwanted products in a solution that provides
chemical destruction and safely neutralizes for shipment to an entity
that will dispose of them safely and legally.
The production, preparation, propagation, compounding, or
processing of drugs but does not include the activities of a repackager,
wholesaler or medical practitioner who distributes or dispenses such
substances in the ordinary course of his or her professional practice
or prepares, compounds, packages or labels such substances.
A person engaged in the manufacture of drugs.
As defined in Chapter 65 of the Kansas Statutes Annotated
and any applicable Kansas Administrative Regulations.
Any drug that may be lawfully sold without a prescription.
An individual, firm, sole proprietorship, corporation, limited
liability company, general partnership, limited partnership, limited
liability partnership, association, cooperative, or other entity of
any kind or nature, however organized.
A place licensed by the state where the practice of pharmacy
is conducted.
The person that develops, implements and operates a stewardship
plan, including but not limited to a producer or stewardship organization.
A stewardship plan required under this chapter that describes
the manner in which a stewardship program will be provided pursuant
to the terms of this chapter.
Any drug, including, but not limited to, any controlled substance,
that is required by federal or state law, rule or regulation to be
dispensed by prescription only or is restricted to use by practitioners
only.
Shall be determined, with regard to covered drugs that are sold,
offered for sale, or distributed in the City as meaning one of the
following:
The person who manufactures covered drugs and who sells, offers
for sale or distributes covered drugs in the City under that person's
own name or brand.
If there is no person who sells, offers for sale, or distributes
covered drugs in the City under the person's own name or brand,
the producer of covered drugs is the owner or licensee of a trademark
or brand under which the covered drugs are sold or distributed in
the City, whether or not the trademark is registered.
Notwithstanding the foregoing, "producer" does not include:
i) a retailer or repackager that only puts its label on a covered
drug; ii) a pharmacist who dispenses prescription drugs to or repackages
or compounds a prescribed individual drug product for a consumer;
or iii) a drug wholesaler who is not also a manufacturer.
Any person that sells or otherwise furnishes drugs to consumers
at a location as defined (health-care facility) by the EPA located
in the City.
Any hearing held by the Department or the City which is open
to the public for the purposes of collecting public comment. It does
not necessarily refer to meetings of the City Commission.
A person who owns or operates an establishment that repacks,
repackages, and/or relabels a product or package (including a covered
drug) for further sale or for distribution without a further transaction.
Any person that sells drugs directly to consumers at a business
located in the City.
A person designated by the City to act as an agent on behalf
of each producer to operate a stewardship program or organization
that the City contracts with to operate a stewardship program.
Covered drugs no longer wanted by the owner or that have
been abandoned, discarded, or are intended to be discarded by the
owner.
A.
The requirement for sale. This chapter shall apply only to producers
whose covered drugs are sold and/or distributed in the City and to
retailers who sell covered drugs in the City. This chapter shall apply
only to areas within the City limits. This chapter shall be administered
and implemented by the City of Parsons Police Chief or another designee.
Each producer shall participate in the stewardship plan. Each producer
must:
(1)
Operate, individually or jointly, with other producers.
B.
Stewardship program costs.
(1)
A producer, or a group of producers, must pay all administrative
and operational fees and costs associated with their stewardship program
and related stewardship plan, including, but not limited to, the cost
of chemical digestion or neutralizing, transporting, and disposing
of unwanted products from consumer generators.
(2)
No person or producer may charge a specific point-of-sale fee to
consumers to recoup the costs of their product stewardship program,
nor may they charge a specific point-of-sale drug disposal fee at
the time the unwanted products are chemically digested or neutralized
from consumer generators or delivered for disposal.
(3)
A producer, or a group of producers, must pay all costs and expenses
incurred by the City, including but not limited to the Department,
in the administration and enforcement of their stewardship program.
Exclusive of fines and penalties, the City shall only recover its
actual costs of administration and enforcement under this chapter
and shall not charge any amounts under this chapter in excess of its
actual administrative and enforcement costs.
(4)
A producer, or a group of producers, must pay all disposal costs
and expenses as of the date that the ordinance codified in this chapter
becomes effective. If the City incurs any costs or expenses due to
delays in the establishment of an approved stewardship plan, the producer,
or group of producers, must reimburse the City in full for such costs.
A.
Plan content. The plan shall contain each of the following:
(1)
Certification through the City contract that the stewardship organization
will accept all unwanted products regardless of who produced them
unless excused from this requirement by the Department as part of
the approval of the plan;
(2)
Contact information (including the name, physical and mailing address,
telephone number, and email address) for the stewardship organization
submitting the plan;
(3)
A description of the methods by which unwanted products from consumer
generators will be chemically digested, neutralized, and handled in
the City, including without limitation a description of the chemical
digestion or neutralization methods used and the immediate neutralizing
of unwanted products;
(4)
A list containing the name, location, permit status, and record of
any penalties, violations, and/or regulatory orders received in the
previous five years by each person that will be involved in chemical
digestion and neutralization, and/or transporting unwanted products
and each medical waste or hazardous waste disposal facility proposed
to participate in the product stewardship plan;
(5)
A description of how the unwanted products will be safely and securely
tracked and handled from chemical digestion and neutralization through
final disposal, including weight accumulated, excluding packaging,
through the program and the policies and procedures to be followed
to ensure security;
(6)
A description of the public education and outreach activities required
under this chapter and how their effectiveness will be evaluated specifically
an in-school education program;
(7)
A description of how the scope and extent of the stewardship plan
are reasonably related to the number of covered drugs that are sold
in the City by the producer or group of producers;
(8)
A starting date when a safe drug disposal of unwanted products will
begin;
(9)
A description of how support will be provided to any law enforcement
agencies within the City that have, or later agree to have, a chemical
digestion and neutralization safe disposal program for controlled
substances, including, without limitation: i) the provision of a safe
drug disposal kiosk for chemical digestion with appropriate accessories
and signage; ii) an ability to accept controlled substances and other
covered drugs; and iii) technical support, up to and including an
appropriate person to provide on-site assistance with the safe drug
disposal kiosks and law enforcement agencies;
(10)
If more than one producer will be involved in a proposed stewardship
plan, then the stewardship plan for that program must include a fair
and reasonable manner for allocating the costs of the program among
the participants in that program, such that the portion of costs paid
by each producer is reasonably related to the number of covered drugs
that producer sells in the City.
B.
Existing county-approved stewardship plan. If a producer, group of producers or stewardship organization is/are operating a stewardship plan within the county under an existing stewardship plan that has been approved by the County of Labette, such producer, group of producers, or stewardship plan may comply with the above by supplementing such county-approved plan to cover the City and include all items listed in Subsection A, plan content, above. The stewardship plan, as supplemented, must be submitted to the Department for review and approval of the provisions relating to and/or applicable to the City.
C.
Department review and approval; updates.
(1)
No producer, group of producers or stewardship plan within the City
may begin chemical digestion or neutralizing through safe disposal
of unwanted products to comply with this chapter until it has received
written approval of its stewardship plan from the Department. The
City may continue safe drug disposal on an interim basis if there
is any delay in establishing a stewardship plan as required under
this chapter. Once approved by the Department, each stewardship plan
must receive prior written approval from the Department for any proposed
changes to the plan.
(2)
All stewardship plans must be submitted to the Department for approval.
Each stewardship organization shall submit its initial stewardship
plan (conforming to the above requirements) to the Department for
review within 60 days after the effective date of this chapter, or
at a later date as approved in writing by the Department.
(3)
Within 60 days after the Department's receipt and review of
a stewardship plan, the Department will determine whether the plan
complies with the requirements of this chapter and of any regulations
adopted pursuant to this chapter. The Department may at its sole discretion
conduct a noticed public hearing as part of this process.
(a)
As part of its approval, the Department may set reasonable performance
goals for the program.
(b)
If the Department approves a plan, it shall notify the applicant
of its approval in writing.
(c)
If the Department rejects a plan, it shall notify the applicant
in writing of its reasons for rejecting the plan. The Department may
reject a plan without conducting a public hearing.
(d)
An applicant whose plan has been rejected by the Department
must submit a revised plan to the Department within 30 days after
receiving notice of the rejection. The Department may require the
submission of a further revised plan or, at its sole discretion, the
Department may (without any obligation to do so) develop, approve
and impose upon the applicant the Department's own stewardship
plan or an approved plan submitted by other producers pursuant to
this chapter. The imposed plan will be presented at a public hearing.
The Department is not required, and nothing in this chapter shall
be interpreted as requiring, the Department to create or impose a
stewardship plan.
(e)
If the Department rejects a revised stewardship plan or any other
subsequently revised plan, the Department may deem the producer(s)
at issue out of compliance with this chapter and subject to the enforcement
provisions contained in this chapter.
(4)
At least every three years, a stewardship plan shall update its stewardship
plan, explaining any substantive changes to components of the plan,
and submit the updated plan to the Department for review and approval.
(5)
A producer who begins to offer a covered drug for sale in the City
after the effective date of this chapter must submit a stewardship
plan to the Department and provide evidence of having joined the existing
approved stewardship plan within 60 days following the producer's
initial offer for sale of a covered drug in the City.
(6)
Any proposed changes to a stewardship plan must be submitted in writing
to the Department and approved by the Department in writing prior
to implementation of any change. Notwithstanding the foregoing, for
county-approved plans, only those changes relating to and/or applicable
to the City must be submitted in writing to the Department for review
and approval before implementation.
(7)
The Department may audit the records of a producer, or group of producers,
related to a stewardship plan, or request that the producer, or group
of producers, arrange for the Department to inspect at reasonable
times the facilities, vehicles, and equipment used in carrying out
the stewardship plan.
A.
Compliance with applicable law. Each stewardship plan must comply
with all local, state, and federal laws and regulations applicable
to its operations, including, but not limited to, laws, rules, and
regulations governing the treatment, chemical digestion and neutralizing
safe disposal of unwanted products.
B.
Treatment and disposal. Each stewardship program must dispose of
all unwanted covered drugs by incineration at a medical waste or hazardous
waste facility authorized to accept such waste. Each treatment and/or
disposal facility utilized must be in possession of all required regulatory
permits and licenses.
C.
New technologies. A stewardship plan may petition the Department
for approval to use treatment and final disposal technologies, where
lawful, that provide superior environmental and human health protection
than provided by current medical waste or hazardous waste disposal
technologies for covered drugs if and when those technologies are
proven and available. The proposed technology, at a minimum, must
provide equivalent protection in each, and superior protection in
one or more, of the following areas:
D.
Packaging separation. The stewardship plan shall allow the consumer
generators to separate unwanted products from their original containers
and packaging prior to safe drug disposal in a container that chemically
digests or neutralizes these items.
A.
A stewardship plan must promote the program to consumer generators,
pharmacists, retailers of covered drugs, and health-care practitioners
(including, but not limited to, doctors and other prescribers, veterinarians
and veterinary hospitals) as to the proper and safe method of storage
and safe disposal of unwanted products using the stewardship organization.
B.
A stewardship plan shall include, but is not limited to, developing,
and updating as necessary, educational and other outreach materials
for use by schools regarding covered drugs. These materials may include:
(1)
Signage that is prominently displayed and easily visible to the children.
(2)
Written materials and templates of materials for reproduction by
schools to be provided to the schools.
(3)
Advertising and/or other promotional materials related to the product
stewardship program.
(4)
An in-school educational program which may include videos, handout
material and webinars.
C.
A stewardship program must prepare education and outreach materials
that publicize the stewardship program in the City and disseminate
the materials to health-care facilities, pharmacies, schools, and
other interested parties. The program also must establish a website
publicizing how the program works and a toll-free telephone number
that consumer generators can call to find safe drug disposal kiosk
locations or acquire more in-home safe disposal bottles as needed
for their personal use.
A.
Within 60 days after the effective date of this chapter (or at a
later date as approved in writing by the Department), each drug wholesaler
that sells any covered drugs in the City must provide a list of the
producers of those covered drugs to the Department in a form prescribed
by the Department. Wholesalers must update and submit to the Department
such list of producers of covered drugs by January 15 of each calendar
year.
B.
Within six months after the effective date of this chapter, or within
six months after a retailer whose label appears on a covered drug
or on the covered drug's packaging starts selling the covered
drug in the City (or at a later date as approved in writing by the
Department), and, thereafter, upon request from the Department, a
retailer whose label appears on a covered drug or on the covered drug's
packaging must provide the contact information of the manufacturer
from whom the retailer obtains the covered drug, including the mailing
address, physical address, telephone number, and email address of
the retailer's point of contact at the manufacturer.
C.
Within six months after the effective date of this chapter, or within
six months after a covered drug repackaged by a repackager is first
sold in the City (or at a later date as approved in writing by the
Department), and, thereafter, upon request from the Department, a
repackager whose label appears on a covered drug or on the covered
drug's packaging must provide the contact information of the
manufacturer from whom the repackager obtains the covered drug, including
the mailing address, physical address, telephone number, and email
address of the repackager's point of contact at the manufacturer.
A.
On or before March 1 (or at a later date as approved in writing by
the Department) and in each subsequent year, every producer, group
of producers, or stewardship organization operating a stewardship
program in the City must prepare and submit to the Department an annual
written report describing the program activities during the previous
reporting period. The report must include, at a minimum, the following:
(1)
A list of producers participating in the stewardship program;
(2)
A list of retailers and/or providers participating in the safe disposal
of consumer-generated covered drugs;
(3)
The amount, by weight, of unwanted products safely destroyed through
chemical digestion or neutralization, disposed from consumer generators
by street, area or the entire City, not to include the weight of packaging
material;
(4)
A description of the safe drug disposal system, including, without
limitation, the process of distribution, tracking, returns, and weight
excluding packaging;
(5)
The name and location of disposal facilities at which unwanted products
were disposed of and the weight of unwanted products, excluding packaging,
collected from consumer generators disposed of at each facility;
(6)
Whether policies and procedures for safe disposal, handling, transporting,
and disposing of unwanted products, as established in the plan, were
followed during the reporting period and a description of any noncompliance;
(7)
Whether any safety or security problems occurred during safe disposal,
handling, transportation, or disposal of unwanted products during
the reporting period and, if so, what changes have or will be made
to policies, procedures, or tracking mechanisms to alleviate the problem
and to improve safety and security;
(8)
A description of public education and outreach activities implemented
during the reporting period and their effectiveness, including, without
limitation, the methodology used to evaluate the outreach and program
activities;
(9)
How the stewardship program complied with all other elements in the
stewardship plan approved by the Department, including, without limitation,
its degree of success in meeting any performance goals set by the
Department as part of its approval of the program; and
(10)
Any other information that the Department may reasonably require.
B.
For the purposes of this section, "reporting period" means the period
beginning January 1 and ending December 31 of the same calendar year.
A.
At least once per year, at a time to be determined by the Department,
each stewardship program will conduct a detailed characterization
study of unwanted products chemically digested or neutralized and
safely disposed to help assess the effectiveness of the stewardship
program.
B.
Assessments shall be conducted in a secure location with proper supervision,
in full compliance with federal and state laws, rules, and regulations,
and in accordance with guidelines issued by the Department.
C.
Data collected from program assessments shall be shared with the
Department and other relevant agencies in a timely manner.
D.
The Department may require additional assessments as needed to address
problems or to help determine program needs.
The Department shall provide on its website a list of all producers
participating in stewardship programs approved by the Department and
a list of all producers the Department has identified as noncompliant
with this chapter or any regulations adopted pursuant to this chapter.
A.
The Director of the Department may, after a noticed public hearing,
adopt such rules and regulations as necessary to implement, administer,
and enforce this chapter.
B.
The City Commission authorizes the Director of the Department to
charge producers or a group of producers participating in a stewardship
program fees to cover all costs the City incurs in administering and
enforcing this chapter. Fees shall not exceed actual costs to the
City. As soon as practicable, the Department shall submit to the City
Commission a proposed schedule of fees to be charged to producers
to cover the City costs of administering and enforcing this chapter.
A.
The Department shall administer the penalty provisions of this chapter.
B.
It shall be unlawful for any person to violate any provision or fail
to comply with any of the requirements of this chapter.
C.
Any person, producer, plan operator or organization that violates
or continues to violate the provisions of this chapter shall be subject
to the penalties, remedies, and criminal, civil and/or administrative
enforcement actions set forth in the Parsons Municipal Code. Each
and every day a violation of this chapter exists constitutes a separate
and distinct offense for which enforcement action may be taken.
D.
In determining the appropriate penalties, the Department shall consider
the extent of harm caused by the violation, the nature and persistence
of the violation, the frequency of past violations, any action taken
to mitigate the violation, and the financial burden to the violator.
E.
Whenever the City finds that a person has violated a provision or
failed to meet a requirement of this chapter, the City may order compliance
by written notice of violation to the responsible person pursuant
to the Parsons Municipal Code.
F.
The Department may establish appropriate administrative rules for
implementing this chapter, conducting hearings and rendering decisions
pursuant to this section.
G.
Upon the failure of any person to comply with any requirement of
this chapter and any rule or regulation adopted pursuant to this chapter,
the City Attorney's office may petition any court having jurisdiction
for injunctive relief, payment of civil penalties and any other appropriate
remedy, including, without limitation, restraining such person or
entity from continuing any prohibited activity and compelling compliance
with lawful requirements. However, this subsection does not permit
the City or any court of competent jurisdiction to restrain the sale
of any covered drug in the City.
H.
Any person who knowingly and willfully violates the requirements
of this chapter or any rule or regulation adopted pursuant to this
chapter is guilty of a Class C misdemeanor. A conviction for a misdemeanor
violation under this chapter is punishable by a fine of not less than
$50 and not more than $500 for each day per violation, or by imprisonment
for a period not to exceed 30 days, or by both such fine and imprisonment.
I.
The remedies provided by this chapter are cumulative and in addition
to any other remedies available at law or in equity.
A.
Disclaimer. In adopting and implementing this chapter, the City is
assuming an undertaking only to promote the general welfare. The City
is not assuming or imposing on its officers and/or employees an obligation
by which they could be liable in money damages to any person or entity
who claims that a breach proximately caused injury.
B.
Conflict with State or Federal Law. This chapter shall be construed
so as not to conflict with applicable federal, state, and county laws,
rules, or regulations. Nothing in this chapter shall authorize any
City agency or department to impose any duties or obligations in conflict
with limitations on municipal authority established by state or federal
law at the time such agency or department action is taken. The City
shall suspend enforcement of this chapter to the extent that said
enforcement would conflict with any preemptive state or federal legislation
subsequently adopted.
C.
Severability. If any of the provisions of this chapter or the application
thereof to any person or circumstance is held invalid, the remainder
of those provisions, including the application of such part or provisions
to persons or circumstances other than those to which it is held invalid,
shall not be affected thereby and shall continue in full force and
effect. To this end, the provisions of this chapter are severable.
D.
Nothing in this chapter, or the stewardship program in which producers
of covered drug products who sell covered drugs in the City are required
to participate, is intended to protect anticompetitive or collusive
conduct, nor shall this chapter be construed to modify, impair, or
supersede the operation of any of the antitrust laws or unfair competition
laws of the State of Kansas or of the United States.
E.
This chapter shall be construed in accordance with state law and
shall not be construed in a way that would result in conflict with,
or preemption by, any such state law.
F.
Environmental findings. This chapter is entitled to a categorical
exemption which exempts actions taken by regulatory agencies, as authorized
by state or local ordinance, to assure the maintenance, restoration,
enhancement, or protection of the environment where the regulatory
process involves procedures for protection.
G.
This chapter shall be in effect for a period of 10 years following
enactment.
