1.Definitions.
As used in this section, unless the context otherwise indicates, the following terms have the following meanings.
2.Manufacturer responsibility.
A manufacturer shall:
3.Submittal of plan.
A manufacturer, individually or jointly with one or more manufacturers, or a stewardship organization contracted by one or more manufacturers, shall submit to the department for approval a proposed plan. The plan must include, at a minimum:
4.Approval of plan; amendments to plan; program audits.
Within 120 business days of receipt of a plan submitted under subsection 3, the department shall review the plan and approve, approve with conditions or reject the plan. The department may hold a public hearing prior to deciding whether to approve, approve with conditions or reject a submitted p
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1.
Definitions.
As used in this section, unless the context otherwise indicates, the following terms have the following meanings.
2.
Manufacturer responsibility.
A manufacturer shall:
3.
Submittal of plan.
A manufacturer, individually or jointly with one or more manufacturers, or a stewardship organization contracted by one or more manufacturers, shall submit to the department for approval a proposed plan. The plan must include, at a minimum:
4.
Approval of plan; amendments to plan; program audits.
Within 120 business days of receipt of a plan submitted under subsection 3, the department shall review the plan and approve, approve with conditions or reject the plan. The department may hold a public hearing prior to deciding whether to approve, approve with conditions or reject a submitted plan. The department shall notify the person or persons that submitted the plan in writing of the department's determination and, if the plan is approved with conditions or rejected, include in the notification the basis for the department's determination.
5.
Costs.
A manufacturer, individually or jointly with one or more manufacturers, shall pay all costs associated with the implementation, administration and operation of the manufacturer's stewardship program, including, but not limited to:
6.
Implementation of plan.
A manufacturer or stewardship organization that submitted a plan under subsection 3 that was approved by the department under subsection 4 shall implement that plan no later than 180 days after the date the plan was approved.
7.
Confidential information.
Proprietary information submitted to the department in a drug take-back stewardship plan under this section, in an amendment to a plan or pursuant to the reporting requirements of this section that is identified by the submitter as proprietary information is confidential and must be handled by the department in the same manner as confidential information is handled under section 1310‑B.
8.
Authorized collectors; collection locations.
This subsection governs the activities of authorized collectors and the operation of collection locations.
9.
Education and outreach assessment.
During the 2nd and 3rd years of implementation of a stewardship program, and every 2 years after that 3rd year, the operator of the program shall fund an independent 3rd-party assessment of the effectiveness of the program's education and outreach efforts, including, but not limited to, progress achieving the consumer awareness goal described in subsection 3, paragraph J, subparagraph (1) and efforts under the program to discourage the use of improper disposal methods for covered drugs that are household pharmaceutical waste, as described in subsection 3, paragraph J, subparagraph (2). The methods and scope of the assessment under this subsection must be developed with input from the department. The operator shall implement changes as necessary to the stewardship program's education and outreach efforts if demonstrated by the results of the assessment.
10.
Annual stewardship program reporting.
Within 90 days after the first full year of implementation of a stewardship program, and annually thereafter, the operator of the program shall submit to the department a report describing the activities of the program during the prior calendar year, which must include, at a minimum:
11.
Administration and enforcement; rulemaking; fees.
The department shall administer and enforce this section and may adopt rules as necessary to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A.
12.
Private right of action.
A manufacturer or stewardship organization implementing an approved plan under this section that is in compliance with all applicable requirements of this section may bring a civil action against a manufacturer for damages when:
13.
Annual report to Legislature.
The department shall annually report to the joint standing committee of the Legislature having jurisdiction over environment and natural resources matters on the status of stewardship programs established pursuant to this section and shall recommend amendments to the provisions of this section as necessary. After reviewing the report under this subsection, the committee may report out legislation related to the report. The report under this subsection may be included in the report required pursuant to section 1772, subsection 1.
14.
Preemption.
To ensure maximum effectiveness through uniform statewide application, the State intends to occupy the whole field of regulation of government‑mandated, manufacturer‑funded drug take‑back, collection or disposal programs. A local government may not adopt an ordinance mandating a manufacturer‑funded drug take‑back, collection or disposal program and any ordinance or regulation that violates this subsection is void and has no force or effect.