DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Solid and Hazardous Waste Commission

Division of Environmental Health and Sustainability

6 CCR 1010-23

STATEMENT OF BASIS AND PURPOSE
AND SPECIFIC STATUTORY AUTHORITY FOR

Rules and regulations pertaining to the Colorado Household Medication Take-Back Program (6 CCR 1010-23). 

Basis and Purpose

I.	Statutory Authority

This Regulation is adopted pursuant to the authority granted to the Solid and Hazardous Waste Commission in Section 25-15-328(7), C.R.S.  This Regulation is a direct result of, and implementation of, House Bill (HB) 14-1207, passed by the legislature in 2014.

II.	House Bill 14-1207

In HB 14-1207, the General Assembly declared (1) that prescription drug abuse is a rampant problem in Colorado, in part due to the accidental and intentional abuse of leftover household medications, and (2) that citizen access to a disposal location to return unused household medications will reduce the availability of household medications for unintended or abusive purposes and will further protect the environment through proper disposal.  HB 14-1207 directed the department’s executive director to establish a household medication take-back program, subject to available funds, to facilitate the safe and effective collection and proper disposal of unused household medications. 

HB 14-1207 codified the department’s earlier-established Colorado Household Medication Take-Back Program (Program); provided liability protection to participants complying with the Program in good faith and complying with applicable laws; created a cash-fund in the state treasury for the direct and indirect costs associated with program implementation consisting of moneys appropriated or transferred to the fund by the General Assembly and any gifts, grants and donations from any public or private entity; authorized the collection of controlled substances approved for collection by federal law, prescription drugs, and over-the-counter medications in the possession of an individual; and granted authority to the Commission to promulgate rules for the Program.  HB 14-1207 does not affect the authority to collect and reuse medications pursuant to Section 12-42.5-133, C.R.S., nor does it prohibit the operation of existing medication take-back and disposal programs regulated by the department.  

III.	Purpose of Regulation:

The purpose of this Regulation is to establish qualifications, operational and recordkeeping procedures, and security requirements for collectors, transporters, and disposal locations participating in the Colorado Household Medication Take-Back Program.  This Regulation also provides access to the Program’s cash fund for department-approved Program participants incurring costs associated with collection, transportation and destruction of household medications, pursuant to the Program and subject to availability.  This Regulation does not affect the collection, transport, or disposal of household medications outside the Program.

Discussion of Regulatory Proposal

I.	Background

The department implemented the Colorado Household Medication Take-Back Program in December 2009.  As of April 1, 2016, the Program had collected more than 60,000 pounds of unused household medications, removing them from homes where they may be misused or abused and directing them to proper disposal.  While successful, the Program’s effectiveness has been limited due to its small geographic coverage - just 11 collection locations in the Denver metropolitan area and Summit County - and due to its inability to collect prescribed controlled substances which have a high potential for abuse.  

A $300,000 legislative appropriation to the Program’s cash fund for FY2015-2016 allowed the department to begin expanding the Program with a goal of establishing at least one permanent collection location in every county. The Drug Enforcement Administration’s (DEA) Final Rule for Disposal of Controlled Substances, effective October 9, 2014, has been used as a basis for this Regulation.  By incorporating this DEA rule, this Regulation aligns with federal law and allows the collection of controlled substances along with other household medications.  Program expansion and the addition of controlled substance collection will increase the Program’s scope and complexity.  This Regulation creates controls to limit opportunities for diversion of collected medications to illicit purposes and meets the intent of HB 14-1207 to facilitate the safe and effective collection and proper disposal of unused household medications.

This Regulation aligns with DEA’s two-category approach to household medication collection.  First, this Regulation allows law enforcement agencies not required to register with DEA to apply for participation in the Program as collectors.  Many law enforcement agencies have been collecting household medications, including controlled substances, since September 2010 through permanent collection receptacles and/or during DEA-funded, biannual National Take-Back Initiative (NTBI) events.  Medications collected through either means have been disposed by DEA during NTBI events.  The future of the NTBI and DEA-funded disposal is uncertain beyond April 2016.  Law enforcement agencies approved by the department to participate in the Program will have access to Program funds, subject to availability.  Second, DEA-registrants, including retail pharmacies and hospitals/clinics with on-site pharmacies, can apply to the Program as collectors if they have amended their DEA registrations to allow collection of controlled substances.  DEA-registrant collectors approved by the department to participate in the Program will also have access to Program funds, subject to availability. The department will develop and adopt guidance that will establish conditions for access to Program funds.

II.	Scope and Purpose, and Applicability

Sections 23.2 and 23.3 discuss to whom this Regulation applies and to whom it does not apply.   Specifically, this Regulation applies to persons participating in the Program as collectors, transporters, or disposal locations.  This Regulation does not apply to persons collecting, transporting, or disposing of household medications outside the Program.

III.	Definitions

Section 23.4 creates twenty-four (24) definitions which apply to this Section 23.  These definitions do not apply to any other regulations promulgated by the Solid and Hazardous Waste Commission or the Board of Health.

IV.	Standards for Program Participants

Sections 23.5 through 23.18 establish standards, qualifications, operational procedures, recordkeeping procedures, and security requirements for collectors, transporters, and disposal locations participating in the Program.

Description of Local Government Involvement in the Stakeholder Process

Executive Order D 2011-005 (EO5), “Establishing a Policy to Enhance the Relationship between State and Local Government” requires state rulemaking agencies to consult with and engage local governments prior to the promulgation of any rules containing mandates.  Although this Regulation contains no mandate, but instead contains requirements for voluntary participation in the Program, the department completed an EO5 – Internal Communication Form – Internal Conception Phase which was transmitted to local governments on July 7, 2014.  The lone respondent to this outreach requested to be included as a stakeholder and participated in the stakeholder process.  

Issues Encountered During Stakeholder Process

Because the department based much of this Regulation on the DEA rule, it did not have wide latitude when drafting this Regulation.  The department held an informal rules development committee meeting on June 10, 2015 to gain input from potential stakeholders before it began drafting this Regulation.  After developing a first draft, the department held five (5) stakeholder meetings between December 2, 2015 and March 24, 2016.  These meetings were part of a comprehensive and robust review process, during which the department collaborated with a stakeholder group including local law enforcement agencies, local public health agencies, pharmacists, educators, health care professionals, drug manufacturers, water and wastewater utilities, waste disposal companies, other Colorado Department of Public Health and Environment division representatives, and the Drug Enforcement Administration.  The stakeholders and department successfully reached consensus on the content of this Regulation.  Based on discussions during the stakeholder process, the following issues were identified as the most consequential to stakeholders and the department: 

I.	Long-term care facilities and narcotic treatment programs are not included as approved collectors

Long-term care facilities (LTCF) and narcotic treatment programs (NTP) are not included as approved collectors in this Regulation.  The DEA rule allows pharmacies or hospitals/clinics with on-site pharmacies to manage and maintain collection receptacles in secure locations at LTCF’s for collection of controlled substances on behalf of present or past residents.  NTP’s are allowed by the DEA rule to collect controlled substances on behalf of their patients, but must locate collection receptacles in locked rooms and accompany patients to the receptacles.  Neither of these scenarios offers broad public access to medication disposal.  Further, LTCF medication wastes are considered to belong to the facilities and are regulated in the Colorado Hazardous Waste Regulations, 6 CCR 1007-3.  Stakeholders indicated no objection to excluding LTCF’s and NTP’s from this Regulation’s list of approved collectors.

II.	DEA-registered manufacturers, DEA-registered reverse distributors, and DEA-registered distributors are not included as approved collectors

DEA-registered manufacturers, DEA-registered reverse distributors, and DEA-registered distributors are not included as approved collectors in this Regulation.  The DEA rule allows these entities to collect controlled substances from ultimate users through collection receptacles or mail-back programs.  As with LTCF’s and NTP’s, the stakeholders indicated no objections to this Regulation’s exclusion of these entities as they would not contribute significantly to broad public access to household medication disposal.  

III.	Medication mail-back is not included as an approved medication collection method

This Regulation does not include medication mail-back as an approved medication collection method.  The DEA rule allows the use of mail-back envelopes by DEA-registrant collectors and law enforcement collectors as a method for collecting controlled substances from ultimate users. This method involves the production and distribution of nondescript envelopes, bearing unique identification numbers for tracking purposes.  The stakeholders indicated no objections to the exclusion of this collection method as it would require an investment in the production of envelopes that may or may not be ultimately used by consumers.  Further, this collection method would require more rigorous management given the large number of envelopes that would need to be tracked from production through destruction. 

IV.	Limit need for “regulation hopping”

Several stakeholders expressed concern that creation of a new regulation would burden them with the need to cross reference these new requirements with requirements existing in other regulations.  To address this concern, the department, where possible, used the actual language from other regulations, rather than merely citing to other regulations.  Where this approach was not deemed feasible or practical, the department limited citation to federal regulations to one section of the federal code – 21 CFR Part 1300, Chapter II.  The stakeholders agreed with this approach.

V.	Continued operation of extra-Program collection

Some stakeholders expressed concern that this Regulation would deter pharmacies from continuing to operate programs that exclude controlled substances from collection.  The General Assembly made clear in section 25-15-238(1) and 25-15-238(2)(d) their intention to establish a program to collect household medications, including controlled substances. However, section 23.2(B)(4) addresses this stakeholder concern because it makes clear that this Regulation does not apply to the operation of other medication take-back and disposal programs.

VI.	Alignment with federal rules

Stakeholders desired that this Regulation align with federal rules intended to expand the options available to collect controlled substances from ultimate users for the purpose of disposal.  To address this, the department based this Regulation extensively on DEA’s October 9, 2014 rule.  This Regulation aligns with DEA’s two-category approach to household medication collection and substantially adopts DEA’s qualification requirements, operational procedures, recordkeeping procedures, and security requirements for collectors, transporters, and disposal locations.  A DEA representative attended stakeholder meetings and DEA comments were incorporated into this Regulation. 

VII.	Concerns of rural, smaller and western slope communities

Some stakeholders expressed concern about manpower and physical constraints that would limit the ability of law enforcement agencies in rural, smaller and western slope communities to comply with the requirements of this Regulation and to participate in the Program.  Specifically, an early draft of this Regulation required two law enforcement agency employees to operate a collection receptacle.  To address this concern, this Regulation allows the department, on a case-by-case basis, to approve the use of one law enforcement agency employee.  Similarly, an early draft of this Regulation required that two law enforcement officers be assigned to a take-back event and maintain control and custody of the collected medications.  To address this concern, this Regulation requires that a minimum of one law enforcement officer be assigned to a take-back event.

Some stakeholders expressed concern that smaller law enforcement agencies might not have sufficient physical space to locate a collection receptacle in an area accessible to the public.  This Regulation allows a law enforcement officer or law enforcement agency employee to take-custody of household medications for immediate transfer to a collection receptacle if it is located in an area not accessible to the public.

VIII.	Use of reserve officers for medication collection by law enforcement

Some stakeholders felt this Regulation should allow law enforcement agencies to use reserve officers to operate collection receptacles or maintain control and custody of medications collected at take-back events.  This Regulation includes a definition of “employee” that allows inclusion of “reserve officers” at the discretion of a law enforcement agency.  The definition of “law enforcement officer” in this Regulation encompasses reserve officers, thereby allowing them to maintain control and custody of medications collected at take-back events, if assigned to the task by a law enforcement agency.

IX.	Local community involvement in take-back events

Several stakeholders expressed a desire to allow local community groups and agencies to voluntarily participate in medication take-back events held by law enforcement agencies.  Stakeholders expressed concern that their participation would be limited if volunteers were not allowed to handle medications turned in for disposal.  This Regulation allows for volunteer participation in take-back events, but in compliance with the DEA rule, does not allow anyone other than law enforcement officers assigned to the event to directly handle controlled substances turned in for disposal.  Since controlled substances may be comingled with non-controlled medications and may not be easily identified as controlled substances, this restriction effectively limits the handling of all medications to law enforcement officers assigned to a take-back event.  However, volunteers can still provide meaningful and necessary support at take-back events such as producing and distributing promotional materials, directing the flow of vehicles and persons, answering questions, and stocking supplies.

X.	Recycling of packaging turned in along with medications at take-back events 

Several stakeholders expressed concern that packaging materials would unnecessarily be disposed of, and increase disposal costs, if they could not be sorted out from medications turned in for disposal at take-back events.  Stakeholders expressed the view that sorting would be impossible if only a law enforcement officers assigned to a take-back event could handle medications.  The Stakeholders agreed that this Regulation does not preclude the development of safe and secure procedures intended to reduce the unnecessary disposal of recyclable packaging materials.  Such procedures could include establishing an area at an event where individuals could sort out and recycle packaging material themselves or the development of event promotional materials encouraging individuals to remove packaging materials at home prior to the event.

XI.	Collector removal of materials deposited into a collection receptacle

Some stakeholders expressed a concern that an early draft of this Regulation prohibited the retrieval of inappropriate materials (e.g. syringes or Schedule I controlled substances), once they are deposited into a collection receptacle and prohibited the inventorying of deposited medications. The stakeholders agreed that handling of deposited items could present safety issues, but this Regulation allows law enforcement agency collectors, if specifically authorized by the department, to access materials deposited into a collection receptacle, prior to the inner liner being sealed. The DEA rule does not disallow this activity by law enforcement agency collectors, but specifically prohibits it by DEA-registrant collectors.

XII.	Enforcement of this Regulation  

Stakeholders questioned how this Regulation would be enforced, since no enforcement authority was granted in HB 14-1207. Since collectors, transporters, and disposal locations must be approved by the department to participate in the Program as described in Sections 23.5 and 23.6, enforcement can be enacted through revocation of their approved status. Furthermore, it is understood by stakeholders and the department that education and guidance will be the initial and preferred approach to promote compliance with this Regulation.  After promulgation of this Regulation, the department will work with stakeholders to draft guidance to assist in the understanding and application of this Regulation; including guidance clarifying how noncompliance with this Regulation may disqualify a participant from the Program.

XIII.	Waste management plan development may be burdensome and costly for law enforcement agency collectors

A stakeholder expressed concern that this Regulation appears burdensome to law enforcement agency collectors, particularly in regard to the required development of waste management plans. The department intends to create guidance to assist Program participants with implementation of this Regulation.  Guidance materials will include a Waste Management Plan template that can be tailored for use by all approved collectors.  Stakeholders will be invited to assist the department with guidance development.

Regulatory Alternatives

No other regulatory alternatives were evaluated.

Cost/Benefit Analysis

A cost benefit analysis will be performed if requested by the Colorado Department of Regulatory Agencies.