HF 1217

as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:45am

A bill for an act
relating to solid waste; requiring a product stewardship program operated
by drug producers to collect and dispose of unwanted drugs; providing civil
penalties; creating an account; proposing coding for new law in Minnesota
Statutes, chapter 115A.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [115A.1410] TITLE.
new text end

new text begin This act may be cited as the Minnesota Safe Drug Disposal Act of 2009.
new text end

Sec. 2.

new text begin [115A.1411] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin For the purposes of sections 115A.1410 to 115A.1419, the
following terms have the meanings given.
new text end

new text begin Subd. 2. new text end

new text begin Covered product. new text end

new text begin "Covered product" means all prescription drugs and all
nonprescription drugs, including both brand name and generic drugs.
new text end

new text begin Subd. 3. new text end

new text begin Drug wholesaler. new text end

new text begin "Drug wholesaler" means a business that sells or
distributes drugs for resale to an entity other than a consumer.
new text end

new text begin Subd. 4. new text end

new text begin Drugs. new text end

new text begin "Drugs" means:
new text end

new text begin (1) articles recognized in the official United States pharmacopoeia, the official
national formulary, the official homeopathic pharmacopoeia of the United States, or any
supplement of the formulary or those pharmacopoeias;
new text end

new text begin (2) substances intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or other animals;
new text end

new text begin (3) substances, other than food, intended to affect the structure or any function of
the body of humans or other animals; or
new text end

new text begin (4) substances intended for use as a component of any substances specified in this
subdivision, but not including medical devices or their component parts or accessories.
new text end

new text begin Subd. 5. new text end

new text begin Entity. new text end

new text begin "Entity" means a person other than an individual.
new text end

new text begin Subd. 6. new text end

new text begin Generic drug. new text end

new text begin "Generic drug" means 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.
new text end

new text begin Subd. 7. new text end

new text begin Mail-back program. new text end

new text begin "Mail-back program" means a system whereby
residential generators of unwanted products obtain prepaid and preaddressed mailing
envelopes in which to place unwanted products for shipment to an entity that will dispose
of them safely and legally.
new text end

new text begin Subd. 8. new text end

new text begin Nonprescription drug. new text end

new text begin "Nonprescription drug" means any drug that
may be lawfully sold without a prescription.
new text end

new text begin Subd. 9. new text end

new text begin Person. new text end

new text begin "Person" means an individual, firm, sole proprietorship,
corporation, limited liability company, general partnership, limited partnership, limited
liability partnership, association, cooperative, or other legal entity, however organized.
new text end

new text begin Subd. 10. new text end

new text begin Plan. new text end

new text begin "Plan" means a product stewardship plan required under section
115A.1413 that describes the manner in which a product stewardship program will be
provided.
new text end

new text begin Subd. 11. new text end

new text begin Prescription drug. new text end

new text begin "Prescription drug" has the meaning given in section
151.44, paragraph (d).
new text end

new text begin Subd. 12. new text end

new text begin Producer. new text end

new text begin (a) "Producer" means a person who has legal ownership of the
brand, brand name, or co-brand of a covered product or manufactures a generic covered
product sold in Minnesota.
new text end

new text begin (b) Producer does not include a retailer who:
new text end

new text begin (1) puts its store label on a covered product;
new text end

new text begin (2) imports a covered product branded or manufactured by a producer who meets the
requirements of paragraph (a) and who has no physical presence in the United States; or
new text end

new text begin (3) sells at wholesale a covered product, does not have legal ownership of the brand,
and elects to fulfill the responsibilities of the producer for that product.
new text end

new text begin Subd. 13. new text end

new text begin Product stewardship program. new text end

new text begin "Product stewardship program" means a
program financed and operated by producers to collect, transport, and recycle unwanted
products.
new text end

new text begin Subd. 14. new text end

new text begin Residential generators. new text end

new text begin "Residential generators" means single and
multiple family residences and locations where household drugs are unused, unwanted,
disposed of, or abandoned, such as hospice services, nursing homes, boarding care homes,
schools, foster care, day care, and other locations where people, pets, or both reside on
a temporary or permanent basis. Residential generators do not include airport security,
drug seizures by law enforcement, pharmacy waste, business waste, or any other source
identified by the agency as a nonresidential source.
new text end

new text begin Subd. 15. new text end

new text begin Stewardship organization. new text end

new text begin "Stewardship organization" means an
organization designated by a group of producers to act as an agent on behalf of each
producer to operate a product stewardship program.
new text end

new text begin Subd. 16. new text end

new text begin Unwanted product. new text end

new text begin "Unwanted product" means any covered product no
longer wanted by its owner or that has been abandoned, discarded, or is intended to be
discarded by its owner.
new text end

Sec. 3.

new text begin [115A.1412] PRODUCT STEWARDSHIP PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Requirement for sale. new text end

new text begin On and after January 1, 2012, no producer
or drug wholesaler may sell or offer for sale covered products in this state unless the
producer of the covered products participates in a product stewardship program to collect
and dispose of unwanted products from residential generators. Each producer must:
new text end

new text begin (1) operate, individually or jointly with other producers, a product stewardship
program approved by the agency; or
new text end

new text begin (2) enter into an agreement with a stewardship organization to operate, on the
producer's behalf, a product stewardship program approved by the agency.
new text end

new text begin Subd. 2. new text end

new text begin Product stewardship program costs. new text end

new text begin (a) A producer, group of producers,
or stewardship organization must pay all administrative and operational costs associated
with their product stewardship program, including the cost 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.
new text end

new text begin (b) No fee may be charged to cover the costs of a product stewardship program at
the time of sale of the covered product or when unwanted products are collected from
residential generators or delivered for disposal.
new text end

Sec. 4.

new text begin [115A.1413] PRODUCT STEWARDSHIP PLAN.
new text end

new text begin Subdivision 1. new text end

new text begin Plan content. new text end

new text begin A product stewardship plan must contain the
following:
new text end

new text begin (1) certification that the product stewardship program will accept all unwanted
products regardless of who produced them;
new text end

new text begin (2) contact information for the individual and the entity submitting the plan and for
all producers participating in the product stewardship program;
new text end

new text begin (3) a description of the methods by which unwanted products from residential
generators will be collected in all counties in the state, including the location of each
collection site and locations where envelopes for a mail-back program are available, and
an explanation of how the collection system will be convenient and adequate to serve the
needs of residents in both urban and rural areas;
new text end

new text begin (4) 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 transporter and
each hazardous waste disposal facility proposed to participate in the product stewardship
program;
new text end

new text begin (5) 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;
new text end

new text begin (6) a description of the public education effort and outreach activities required under
section 115A.1415 and how their effectiveness will be evaluated; and
new text end

new text begin (7) a starting date when collection of unwanted products will begin.
new text end

new text begin Subd. 2. new text end

new text begin Agency review and approval; updates. new text end

new text begin (a) No producer, group of
producers, or stewardship organization may begin collecting unwanted products until it
has received written approval of its product stewardship plan from the agency.
new text end

new text begin (b) Product stewardship plans must be submitted to the agency for approval. The
initial plans must be submitted by January 1, 2011. The agency may consult with other
state agencies regarding the plan.
new text end

new text begin (c) Within 90 days after receipt of a plan, the agency shall determine whether the
plan complies with sections 115A.1410 to 115A.1419. If it approves a plan, the agency
shall notify the applicant of its approval in writing. If it rejects a plan, the agency shall
notify the applicant in writing of its reasons for rejecting the plan. An applicant whose
plan has been rejected by the agency must submit a revised plan to the agency within 60
days after receiving notice of the rejection.
new text end

new text begin (d) At least every four years, a producer, group of producers, or stewardship
organization operating a product stewardship program must update its product stewardship
plan and submit the updated plan to the agency for review and approval.
new text end

new text begin (e) A producer who begins to offer covered products for sale in Minnesota after
January 1, 2011, must submit a product stewardship plan to the agency or provide
evidence of having joined an existing approved plan at least 90 days prior to the producer's
initial offer of sale of covered products.
new text end

new text begin (f) Any proposed changes to a product stewardship plan must be approved by the
agency in writing.
new text end

Sec. 5.

new text begin [115A.1414] DISPOSAL OF UNWANTED PRODUCTS.
new text end

new text begin Subdivision 1. new text end

new text begin Disposal at hazardous waste facility. new text end

new text begin Each product stewardship
program must dispose of all unwanted products from residential generators at a hazardous
waste facility. Unwanted products from residential generators otherwise retain all other
generator exemptions for household hazardous waste. The hazardous waste facility
must be:
new text end

new text begin (1) in possession of a valid permit from the agency;
new text end

new text begin (2) authorized to manage hazardous waste by another state with a hazardous waste
program approved by the United States Environmental Protection Agency; or
new text end

new text begin (3) authorized under interim status or permitted by the United States Environmental
Protection Agency.
new text end

new text begin Subd. 2. new text end

new text begin Alternative disposal technologies. new text end

new text begin Product stewardship programs may
petition the agency for approval to use final disposal technologies that provide superior
environmental and human health protection compared with current hazardous waste
disposal technologies for drugs. The agency may not approve the use of an alternative
proposed technology unless the petitioners have presented clear and convincing evidence
that the technology's performance under field conditions provides equivalent protection in
each, and superior protection in one or more, of the following areas:
new text end

new text begin (1) monitoring emissions or waste;
new text end

new text begin (2) worker health and safety;
new text end

new text begin (3) air, water, or land emissions contributing to persistent, bioaccumulative, and
toxic pollution; and
new text end

new text begin (4) overall impact to the environment and human health.
new text end

new text begin Subd. 3. new text end

new text begin Packaging separation. new text end

new text begin Each product stewardship program is encouraged
to separate unwanted products from their original containers, when appropriate, prior
to collection or disposal.
new text end

Sec. 6.

new text begin [115A.1415] PRODUCT STEWARDSHIP PROGRAM PROMOTION
AND OUTREACH.
new text end

new text begin (a) A product stewardship program must promote the program to residential
generators, pharmacists, retailers of covered products, and health care practitioners as the
proper and safe method to dispose of unwanted drugs.
new text end

new text begin (b) A product stewardship program must prepare education and outreach materials
that publicize the location and operation of collection locations throughout the state and
disseminate them to health care facilities, pharmacies, and other interested parties. The
program must also establish a Web site publicizing collection locations and program
operations and a toll-free telephone number that residential generators can call to find
nearby collection locations and understand how the program works.
new text end

Sec. 7.

new text begin [115A.1416] REPORT.
new text end

new text begin On or before June 30, 2013, and in each subsequent year, every producer, group of
producers, or stewardship organization operating a product stewardship program must
prepare and submit to the agency an annual report describing the program's activities
during the previous reporting period. The report must include the following:
new text end

new text begin (1) a list of producers participating in the product stewardship program;
new text end

new text begin (2) the amount, by weight, of unwanted products collected from residential
generators collected at each drop-off site and in the entire state and the total amount by
weight collected by a mail-back program, if applicable;
new text end

new text begin (3) a description of the collection system provided in each county, including the
location of each collection site and locations where envelopes for a mail-back program are
provided, if applicable;
new text end

new text begin (4) the name and location of disposal facilities at which unwanted products were
disposed of and the weight of unwanted products collected from residential generators
disposed of at each facility;
new text end

new text begin (5) if packaging was separated from the unwanted product prior to disposal of the
unwanted product, the amount and percentage of packaging recycled and the name and
location of the material recovery facility to which it was delivered;
new text end

new text begin (6) whether policies and procedures for collecting, transporting, and disposing of
unwanted products, as established in the plan, were followed during the reporting period
and a description of any noncompliance;
new text end

new text begin (7) whether any safety or security problems occurred during collection,
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;
new text end

new text begin (8) a description of public education and outreach activities implemented during the
reporting period, including the methodology used to evaluate the outreach and program
activities;
new text end

new text begin (9) how the product stewardship program complied with any other elements in the
plan approved by the agency; and
new text end

new text begin (10) any other information that the agency may reasonably require.
new text end

new text begin For the purposes of this section, "reporting period" means the period beginning
January 1 and ending December 31 of the same calendar year.
new text end

Sec. 8.

new text begin [115A.1417] FEES.
new text end

new text begin The agency may establish fees to administer sections 115A.1410 to 115A.1419. The
fees may be charged to producers or to a stewardship organization. Fees may be charged
to fully cover but not exceed the agency's costs of administering sections 115A.1410
to 115A.1419. All fees must be paid to the commissioner for deposit in the account
established in section 115A.1419.
new text end

Sec. 9.

new text begin [115A.1418] ENFORCEMENT.
new text end

new text begin Subdivision 1. new text end

new text begin Generally. new text end

new text begin Sections 115A.1410 to 115A.1419 shall be enforced in
the manner provided by section 115.071, subdivisions 1 to 6.
new text end

new text begin Subd. 2. new text end

new text begin Producer penalties. new text end

new text begin (a) Upon first determining that a producer is offering
a covered product for sale in this state but is not participating in a product stewardship
program approved by the agency, the agency shall send the producer a written warning
that the producer is in violation of section 115A.1412, subdivision 1.
new text end

new text begin (b) A producer not participating in a product stewardship program approved by the
agency whose covered product continues to be sold in this state 60 days after receiving a
written warning from the agency must be assessed a penalty of $10,000 for each calendar
day that the violation continues.
new text end

new text begin (c) If a plan approved under section 115A.1413, subdivision 2, is not fully
implemented within 30 days of the start date contained in the plan, the agency shall
assess a penalty of $5,000 along with notification to each producer associated with the
product stewardship program. If, after an additional 30 days, an approved plan is not fully
implemented, the agency shall assess a penalty of $10,000 to each producer associated
with the product stewardship program. Subsequent violations occur each 30 days that the
approved plan is not fully implemented.
new text end

new text begin (d) When the agency finds that a product stewardship program is not in compliance
with the requirement to update its plan under section 115A.1413 or the reporting
requirements under section 115A.1416, the agency must notify in writing each producer
in the product stewardship program of the violation and must allow the producers in the
product stewardship program 30 days to correct the noncompliance. After 30 days, each
producer in the product stewardship program must be assessed a penalty of $5,000 for the
first violation and $10,000 for each subsequent violation. A subsequent violation occurs
after each 30 days of noncompliance under this paragraph.
new text end

new text begin (e) All penalties levied under this section must be deposited into the pharmaceutical
product stewardship program account established under section 115A.1419.
new text end

new text begin Subd. 3. new text end

new text begin Wholesaler penalties. new text end

new text begin (a) The agency shall provide on its Web site a list of
all producers participating in product stewardship programs the agency has approved and
a list of all producers the agency has identified as noncompliant with sections 115A.1410
to 115A.1419.
new text end

new text begin (b) It is the responsibility of a drug wholesaler offering covered products for sale
in this state to view the agency's Web site to determine if a producer of products the
wholesaler is offering for sale in this state is in compliance with sections 115A.1410
to 115A.1419. If a drug wholesaler is unsure of the status of a producer or believes a
producer is not in compliance, the drug wholesaler shall contact the agency to determine
the producer's status.
new text end

new text begin (c) The agency shall send a written notice to a drug wholesaler known to be selling a
product in this state from a producer who is not in compliance with sections 115A.1410
to 115A.1419.
new text end

new text begin (d) A drug wholesaler that continues to sell a covered product from a producer
that is not in compliance with sections 115A.1410 to 115A.1419 60 days after receiving
a written notice from the agency must be assessed a penalty of $1,000 for each day of
noncompliance.
new text end

new text begin (e) All penalties levied under this section must be deposited into the pharmaceutical
product stewardship program account established under section 115A.1419.
new text end

Sec. 10.

new text begin [115A.1419] ACCOUNT.
new text end

new text begin The pharmaceutical product stewardship program account is created in the
environmental fund. All receipts from fees collected under section 115A.1417 and from
penalties collected under section 115A.1418 must be deposited into the account. Funds
in the account at the end of a fiscal year do not cancel to the general fund, but remain
in the account.
new text end

Sec. 11. new text begin EFFECTIVE DATE.
new text end

new text begin Sections 1 to 10 are effective the day following final enactment.
new text end