6 Colo. Code Regs. § 1007-3-8.95
These amendments to 6 CCR 1007-3, Parts 261, 262, 264, 265, 267, 268, 273 and 100 are made pursuant to the authority granted to the Solid and Hazardous Waste Commission in § 25-15-302(2), C.R.S.
Hazardous Waste Pharmaceutical Rule and Amendment to P075 Listing for Nicotine
These amendments to the Colorado Hazardous Waste Regulations (6 CCR 1007-3) create a new Part 267, Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors in lieu of the generator regulations in Part 262. These amendments correspond to the Environmental Protection Agency (EPA) rule published in the Federal Register on February 22, 2019 {84 FR 5816-5950}, and which became effective on August 21, 2019.
The Part 267, Subpart P - Hazardous Waste Pharmaceuticals regulations are comprised of the following sections:
Part 267, Subpart P - Hazardous Waste Pharmaceuticals | |
Section | Title |
§ 267.500 | Definitions for this subpart. |
§ 267.501 | Applicability and incorporation by reference. |
§ 267.502 | Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals. |
§ 267.503 | Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals. |
§ 267.504 | Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste. |
§ 267.505 | Prohibition of sewering hazardous waste pharmaceuticals. |
§ 267.506 | Conditional exemption for hazardous waste pharmaceuticals that are also controlled substances and household hazardous waste pharmaceuticals collected in a take-back event or program. |
§ 267.507 | Residues of hazardous waste pharmaceuticals in empty containers. |
§ 267.508 | Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor. |
§ 267.509 | Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor. |
§ 267.510 | Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors. |
Amendments being adopted pursuant to this rulemaking include:
* prohibiting the disposal of hazardous waste pharmaceuticals down the drain (§ 267.505);
* eliminating the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances (§ 267.506);
* maintaining the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal (§ 267.506);
* redefining when containers that held hazardous waste pharmaceuticals are considered "RCRA empty" (§ 267.507); and
* revising the P075 hazardous waste listing for nicotine in § 261.33(e) such that Food and Drug Administration (FDA)-approved over-the-counter (OTC) nicotine replacement therapies (NRTs) (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded. Note: e-cigarettes, e-liquids, and prescription NRTS are not exempted from the P075 hazardous waste listing.
The Subpart P regulations apply to healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals and reverse distributors engaged in the management of prescription hazardous waste pharmaceuticals. The Part 267, Subpart P regulations are considered, on the whole, more stringent than the existing regulations, and will be mandatory for all healthcare facilities generating above VSQG monthly quantity thresholds.
The Sewer Prohibition at § 267.505 of the regulations prohibits all healthcare facilities, including very small quantity generators operating under § 262.14 in lieu of this subpart, and reverse distributors from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. Healthcare facilities and reverse distributors remain subject to the prohibitions in 40 CFR § 403.5(b)(1).
Section 267.506 provides a conditional exemption for hazardous waste pharmaceuticals that are also controlled substances under the Drug Enforcement Agency (DEA) regulations, and also for household hazardous waste pharmaceuticals collected in a take-back event or program. To qualify for the DEA-controlled substance exemption, the hazardous waste pharmaceuticals must:
Section 267.507 establishes a new definition of "RCRA-empty" for the management of residues in pharmaceutical containers, and includes provisions for the following types of containers:
The amendment of the P075 hazardous waste code listing for nicotine in § 261.33(e) to exempt FDA-approved OTC NRTs from the P075 listing is less stringent than existing state standards, and Colorado is not required to adopt this amendment. The Environmental Protection Agency, however, encourages states to adopt this amendment to promote national consistency. This amendment provides state equivalency with the regulatory requirements of the Environmental Protection Agency.
The Commission has evaluated the information presented at the rulemaking hearing, as well as the information in the Statement of Basis and Purpose. The Commission considers this information sufficient to justify adopting the proposed rule. The Commission finds that this rule is necessary to protect the public health and environment of the state.
This Basis and Purpose incorporates by reference the applicable portions of the preamble language for the EPA regulations as published in the Federal Register at 84 FR 5816-5950, February 22, 2019.
Statement of Basis and Purpose Rulemaking Hearing of May 19, 2020
6 CCR 1007-3-8.95