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

Amendments to rules and regulations governing 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. The regulation was initially adopted in May 2016, as a result of General Assembly passage of House Bill 14-1207.  Amendments adopted in February 2020 are the result of General Assembly passage of Senate Bill 19-227 in 2019.

II.	House Bill 14-1207

In House Bill 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. House Bill 14-1207 directed the Colorado Department of Public Health and Environment’s (department) 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. 

III.	Senate Bill 19-227

In Senate Bill 19-227, the General Assembly directed the department’s executive director to expand the Colorado Household Medication Take-Back Program (program) through implementation of processes and establishment of locations for the safe collection and disposal of needles, syringes, and other devices used to inject medications (sharps).

IV.	Purpose of Regulation Amendments:

The primary purpose of the regulation amendments is implementation of Senate Bill 19-227, through establishment of qualifications, operational procedures, and recordkeeping requirements for program collectors, transporters, treatment facilities, and disposal locations of household sharps. Additional amendments add clarity and experience-based changes to sections of the regulation dealing with household medication collection, transport and disposal. 

Discussion of Regulatory Proposal

I.	Background

The department implemented House Bill 14-1207 in 2016, by establishing the Colorado Household Medication Take-Back Program, capable of accepting prescribed controlled substances along with other prescription and over-the-counter medications for disposal. A $300,000 legislative annual appropriation allowed the department to embark on a statewide program expansion with a goal of establishing at least one permanent collection location in every Colorado county and in a majority of cities with populations of 1,000 or more. 

As of October 31, 2019, the program had enrolled more than 160 collection sites in 62 of Colorado’s 64 counties and collected more than 90,000 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 lacked the ability to collect sharps used by the public to administer a significant volume of medications. If handled or disposed improperly, these devices pose a risk for injury and transmission of bloodborne pathogens. Options for safe disposal are offered by some drug manufacturers, local agencies, or others, but such services are limited in scope and geographic coverage. The implementation of SB 19-227 through amendments to 6 CCR 1010-23, (1) expands the existing, state-funded program for the collection and disposal of household medication waste to include sharps, (2) potentially decreases trash disposal of used sharps by offering a broadly available, no-fee system for collection and disposal, and (3) potentially reduces confusion regarding available options for safe sharps disposal. The legislature appropriated funds, for fiscal year 2020 and beyond, for development and implementation of the sharps element of the program. 

II.	Scope, Purpose, and Applicability

The amendments to Section 23.2(A) of the proposed regulations emphasize that a program participant may volunteer to collect household medications or household sharps, or both, and establishes that the regulations apply to program participants involved in the collection, transport, treatment and disposal of household sharps. The amendments to section 23.2(B) add an exclusion for household sharps collection activities taking place through other programs and clarifies that those generating the household medications and household sharps are not covered by the regulation. Section 23.2(B)(6) was amended to incorporate by reference the definition of schedule I controlled substances as defined in U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1308 revised April 1, 2019. The amendments to Section 23.2(C) clarify that department-contracted program participants incurring costs related to medications or sharps may apply for reimbursement. Amended Section 23.3 establishes the regulation’s applicability to the collection, transport, treatment and disposal of sharps.

III.	Definitions

The amendments added two new definitions to Section 23.4(A). A definition of household sharps was added as Section 23.4(A)(17) and a definition of treatment facility was added as Section 23.4(A)(25). Although the definition was not amended, the term “take-back event” was changed to “household medication take-back event” and is now included as 23.4(A)(16). Several definitions were amended to include the collection, transport, treatment and disposal of sharps. These definitions do not apply to any other regulations promulgated by the Solid and Hazardous Waste Commission or the Board of Health. Definitions for the terms “controlled substance”, “DEA registrant or registrant”, “distribute”, and “distributor” were amended to incorporate by reference various sections of U.S. Department of Justice, Drug Enforcement Administration regulations at 21 CFR §§ 1301, 1308, and 1310, revised April 1, 2019.

IV.	Standards for Program Participants – Household Medication

Part I - Sections 23.6 through 23.18 establish standards, qualifications, operational procedures, recordkeeping procedures, and security requirements for household medication collectors, transporters, and disposal locations participating in the Program. Amendments added two new sections, based on the department’s experiences with the program, including Section 23.13.4 which allows a transporter to transfer medications to another DEA-registrant for subsequent destruction, and Section 23.17.2(A)(3) which allows for department-approved, alternative inner-liner documentation methods by law enforcement agencies. Several sections were amended for clarity, including the replacing the terms “reverse distributor” and “distributor” with the term “transporter.” Requirements for collector registration [23.6.1 (A)(1)], transporter physical security controls [23.15.4(A)], recordkeeping [23.16.1(A)], transporter records and reports [23.16.3(A)], collector records and reports [23.16.3(B)], and collector termination of registration [23.18(A)(3)] were amended to incorporate by reference various sections of the U.S. Department of Justice, Drug Enforcement Administration regulations at 21 CFR §§ 1301 and 1304, revised April 1, 2019.

V.	Standards for Program Participants – Household Sharps

The amendments added Part II - Section 23.19, establishing standards, qualifications, operational procedures, and recordkeeping procedures for household sharps collectors, transporters, treatment facilities, and disposal locations. 

VI.	Federal Regulations Incorporated by Reference

The amendments added Section 23.20, incorporating by reference applicable sections of the United States Department of Justice, Drug Enforcement Administration (DEA) regulations and United States Department of Labor, Occupational Safety and Health Administration (OSHA) regulations.

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 sharps-expanded medication take-back program, the department completed an EO5 – Internal Communication Form – Draft Phase which was transmitted to local governments on July 1, 2019. Four respondents to this EO5 outreach requested to be included as stakeholders and provided an opportunity to participate in the stakeholder process.  

Stakeholder Engagement
 
The department held a Rules Committee meeting on July 31, 2019 to gain input from potential stakeholders before it began drafting the amended regulation. After developing a first draft, the department held three stakeholder meetings on October 11, November 8 and November 20, 2019. 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, department representatives and others. The stakeholders and department successfully reached consensus on the content of the amended regulation. Based on discussions during the stakeholder process, the following issues were identified as the most consequential to stakeholders and the department with regard to the expansion of the Program to include the safe collection and disposal of sharps: 

I.	Medication collectors should not be required to also collect sharps

Stakeholders expressed concern that program expansion would result in a requirement for medication collectors to also collect sharps. Program participants successfully incorporating medication collection into their business practices may not be able to handle the additional burden of sharps collection. The initial regulation established the voluntary nature of the program. The amendments establish that collection of household medications or household sharps are both done voluntarily.

II.	The regulation amendments must be protective of public safety and the safety of program participants

Sharps collection receptacle construction - Several stakeholders expressed the need for sharps collection receptacles to be constructed in such a manner as to reduce the risks of injury and transmission of bloodborne pathogens. The amended regulation does not mandate a particular receptacle design, but states they must have department approval. The department intends to use the Request for Proposals (RFP) process to require transporter submission of safe collection receptacle designs and will consider the appropriateness of those designs when selecting a program transporter. 

Sharps collection receptacle placement - The amended regulation requires that sharps collection receptacles be placed at a collector’s physical location in an area regularly monitored by employees. This requirement is intended to reduce opportunities for improper use of a kiosk, i.e. placement of loose sharps in receptacles not intended for such deposits, contamination of receptacles with bodily fluids, and deposit of trash or other items that might interfere with safe receptacle operation. The amended regulation does not prohibit the installation of collection receptacles outdoors. The department will consider approval of outdoor placements, if they can be accomplished in a safe manner.

Sharps collection site housekeeping - Stakeholders expressed the need for good housekeeping at sharps collection sites to reduce the risks of injury, including transmission of bloodborne pathogens. This issue was deemed appropriate for inclusion in Medical Waste Management Plans.

Safety training - The amended regulation incorporates by reference and requires sharps collectors to provide training to employees in accordance with U.S. Department of Labor, Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens standard, 29 CFR § 1910.1030(g)(2), effective June 4, 1992. Also, department-approved collectors must describe the training in their Medical Waste Management Plans and must maintain documentation of training for three years from the date on which the training occurred. The amended regulation also includes a requirement for transporter employee training in accordance with Regulations Pertaining to Solid Waste Sites and Facilities, 6 CCR 1007-2, Part 1, Part B, Section 13.7.2(C)(9).

Sharps shipping - Stakeholders stated that the shipping of sharps by transporters via common or contract carrier should utilize containers that comply with Department of Transportation regulations or carrier standards. The department intends to use the RFP process to require use of compliant shipping containers and methods and will consider their appropriateness when selecting a program transporter.

Sharps treatment - The amended regulation requires transporter treatment of acquired sharps to a non-infectious state prior to disposal. The possibility exists that treatment may occur outside the state of Colorado. The amended regulation allows for department approval of treatment methods that may be permissible in other states, but not specifically listed in the Regulations Pertaining to Solid Waste Sites and Facilities, 6 CCR 1007-2, Part 1, Part B, 732 Section 13.6.1(A).

III.	A mail-back option for sharps containers should be allowed

Several stakeholders expressed the need for a mail-back option, whereby a transporter provides sharps containers directly to individuals. This option would allow an individual to obtain sharps containers directly from a transporter and then have them delivered back to the transporter when full. Stakeholders felt this option might prove more economical and may better serve rural areas of the state, where collection sites might be located too far from residents who need them. The mail-back option was included in the amended regulation by allowing transporters to receive sharps directly from individuals by common or contract carrier delivery. 

IV.	The homeless and those injecting illicit drugs should not be excluded from the program

Several stakeholders stated that the homeless and those injecting illicit drugs should not be excluded from using sharps collection receptacles. The amended regulation does not exclude these groups. Sharps that are in the possession of an individual will be accepted, provided they were not generated by a commercial or industrial entity. Generators of the deposited sharps are not covered by the amended regulation, so no questions will be asked regarding the use of the injection devices. The amended regulation allows for department-approved outdoor kiosk placements. Such approval may be granted in areas that could benefit from outdoor access.

V.	Household sharps collection events or mobile collection should be offered

Stakeholders expressed an interest in allowing sharps take-back events or offering mobile sharps collection options. While these options are not addressed specifically in the amended regulation, the department may choose to pilot such efforts with collection sites if specific needs are identified and sufficient funding is available.

VI.	Collectors should maintain manifests documenting transporter acquisition of sharps from their locations

Stakeholders stated that collectors should maintain manifests or other documentation demonstrating that collected sharps were transferred to a transporter for treatment and disposal. Since it will not be known what paperwork might be generated until a transporter is chosen and procedures implemented, the amended regulation states that collectors shall maintain transporter-provided waste manifests, tracking documents, or chain-of-custody forms for three years.

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.