Change of Law: Hospital Action Required
|To:||Chief Operating Officers, Legal Counsel and Government Affairs Staff
Please forward to waste management staff
|From:||David Streeter, MPA, Policy Director- Clinical and Data
DavidS@wsha.org | (206) 216-2508
|Subject:||Federal Pharmaceutical Waste Standards Effective October 31, 2020|
The purpose of this bulletin is to inform hospitals that the federal Environmental Protection Agency’s (EPA) Management Standards for Hazardous Waste Pharmaceuticals will take effect in Washington state on October 31, 2020. The Department of Ecology (Ecology) adopted the EPA’s standards in new WAC 173-303-555 to provide clarity and ensure consistency between state and federal regulations. The EPA’s regulations first took effect August 21, 2019, and Ecology’s subsequent adoption may require modifications to your current dangerous waste management practices if your hospital is out of compliance with the federal standards.
The adopted standards apply to all hospitals and health care facilities in Washington state. Compliance requirements are determined by waste generation quotas.
The regulations apply to potentially creditable and noncreditable dangerous waste pharmaceuticals. Potentially creditable waste may be reused or returned to its manufacturer, while noncreditable waste cannot be reused.
See the “Definitions” and “Detailed Applicability” sections below for details.
- Review this bulletin, WAC 173-303-170, and WAC 173-303-555 to understand the adopted regulations.
- Implement, if necessary, internal changes needed to comply with the adopted regulations.
- Speak with your reverse distributor and/or your dangerous waste disposal vendor(s) to ensure compliance with WAC 173-303-555’s shipping and packaging provisions.
Dangerous waste in Washington State is regulated under Chapter 173-303 WAC. The adopted standards in new WAC 173-303-555 bring Washington State into compliance with existing EPA regulations. The regulations specify requirements for managing dangerous pharmaceutical waste; prohibit disposing dangerous waste pharmaceuticals in sewer systems; and require health care facilities to follow specific labeling, shipping, and disposal instructions procedures.
WAC 173-303-555 (1) defines the types of dangerous pharmaceutical waste subject to the adopted regulations:
Noncreditable dangerous waste pharmaceutical: means a prescription dangerous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription dangerous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed. This includes, but is not limited to, investigational drugs, free samples of pharmaceuticals received by health care facilities, and residue of pharmaceuticals remaining in empty containers, pharmaceutical contaminated personal protection equipment, floor sweepings, and clean-up materials from the spills of pharmaceuticals.
Potentially creditable dangerous waste pharmaceutical: means a prescription dangerous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and is:
(a) In original manufacturer packaging (except pharmaceuticals that were subject to a recall); and
(b) Undispensed; and
(c) Unexpired or less than one-year past expiration date.
This term does not include evaluated dangerous waste pharmaceuticals or nonprescription pharmaceuticals including, but not limited to, over the-counter drugs, homeopathic drugs, and dietary supplements.
The adopted EPA regulations apply differently to small quantity, medium quantity, and large quantity dangerous waste generators.
Medium and Large Quantity Waste Generators
WAC 173-303-170 (10) classifies health care facilities as medium and high quantity dangerous waste generators if they generate more than these quantities of dangerous waste:
(a) 220 pounds (100 kg) of dangerous waste; or
(b) 2.2 pounds (1 kg) of either acute hazardous waste or WT01 extremely hazardous waste or any combination of the two; or
(c) 220 pounds (100 kg) of any residue or contaminated soil, water, or other debris, resulting from the clean-up of a spill, into or on any land or water, of any acute hazardous waste and/or WT01 extremely hazardous waste.
If a health care facility generates more than the above quantities of dangerous waste, then the facility is subject to all of WAC 173-303-555 and the applicable existing regulations in Chapter 173-303 WAC.
Small Quantity Waste Generators
Health care facilities that generate less than the above quantities specified by WAC 173-303-170 (10) are considered small quantity dangerous waste generators. In such cases, WAC 173-303-170 (11) requires small quantity generators to comply with only two provisions in WAC 173-303-555:
- WAC 173-303-555 (6) – Prohibition of sewering dangerous waste pharmaceuticals
- WAC 173-303-555 (8)– Residues of dangerous waste pharmaceuticals in empty containers
Small quantity generators are still subject to applicable existing regulations in Chapter 173-303 WAC.
Small quantity generators may also choose voluntarily to comply with:
- WAC 173-303-555 (5)- Health care facilities that are small quantity generators for both dangerous waste pharmaceuticals and nonpharmaceutical dangerous waste
- WAC 173-303-555 (8)- Residues of dangerous waste pharmaceuticals in empty containers
Standards for Waste Management
The adopted standards apply to two types of dangerous pharmaceutical waste: noncreditable and potentially creditable. Please see the “Definitions” section above for the definitions.
WAC 173-303-555 (3) – Standards for health care facilities managing noncreditable dangerous waste pharmaceuticals.
This section specifies how health care facilities must collect and store noncreditable dangerous waste pharmaceuticals. The major provisions that may require hospital action at this time are:
- Health care facilities must notify Ecology with a Washington State Dangerous Waste Site Identification Form that they are “operating under this section.”
- Health care facilities must collect waste in containers that are “structurally sound, compatible with its contents,” and show no signs of leakage or potential leakage. The containers must also be labeled with the phrase “Hazardous Waste Pharmaceuticals” or “Dangerous Waste Pharmaceuticals.”
- Health care facilities must “ensure that all personnel who manage noncreditable dangerous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures.”
- Health care facilities that accumulate noncreditable dangerous waste pharmaceuticals must adhere to the storage, inventory, and recordkeeping provisions specified in this section.
- Health care facilities that collect noncreditable dangerous waste pharmaceuticals from offsite facilities that are small quantity generators must adhere to the ownership and recordkeeing provisions contained in WAC 173-303-555 (3)(o).
Please see WAC 173-303-555 (3) for the full standard requirements.
WAC 173-303-555 (4)- Standards for health care facilities managing potentially creditable dangerous waste pharmaceuticals.
This section specifies waste determination procedures; requirements for receiving potentially creditable dangerous waste pharmaceuticals from off-site health care facilities that are small quantity generators; and recordkeeping provisions. Action may be required at this time to comply with this section. Please see WAC 173-303-555 (4) for the full standard requirements.
WAC 173-303-555 (6)- Prohibition of sewering dangerous waste pharmaceuticals.
This section prohibits health care facilities from disposing of their dangerous waste pharmaceuticals through any “sewer system that passes through to a publicly owned treatment works or to an on-site disposal system.” Compliance with this section ensures dangerous waste pharmaceuticals do not contaminate local water supplies.
WAC 173-303-555 (7)- Conditional exemptions for dangerous waste pharmaceuticals that are also controlled substances and household waste pharmaceuticals collected in a take-back event or program.
This section exempts scheduled controlled substances and household waste pharmaceuticals from WAC 173-303-555. Scheduled controlled substances are designated as such in 21 CFR § 1308. Household waste pharmaceuticals are anything collected through either a drug takeback program or event. These two types of pharmaceutical wastes are subject to the Drug Enforcement Agency’s (DEA) current drug disposal regulations, which specify collection, storage, transportation, and destruction procedures.
WAC 173-303-555 (8)- Residues of dangerous waste pharmaceuticals in empty containers.
This section defines whether used containers are empty or not empty, and how to dispose of them. In general, empty or partially empty containers are noncreditable dangerous waste and subject to WAC 173-303-555 (3). This applies to syringes, IV bags, and other containers, including delivery devices. However, subsection (a) clarifies that stock, dispensing, and unit-dose containers are not regulated as dangerous waste if they have been emptied “using practices commonly employed to remove materials in that type of container.” Please see WAC 173-303-555 (8) for the full standard requirements.
Shipping Dangerous Waste Pharmaceuticals
WAC 173-303-555 (9) and (11) contain the requirements for shipping dangerous waste pharmaceuticals.
WAC 173-303-555 (9) addresses noncreditable dangerous waste pharmaceuticals. It contains specific requirements for the shipping and transport of noncreditable dangerous waste pharmaceuticals. This includes label and manifest requirements that may require action to comply.
WAC 173-303-555 (11) addresses potentially creditable dangerous waste pharmaceuticals. This section defers to current Department of Transportation regulations contained in 49 CFR § 171-180.
Please see WAC 173-303-555 (9) and (11) for the full standards.
WAC 173-303-555 (10)- Disposal of state-only dangerous waste pharmaceuticals.
This section states the types of incinerators that may be used for the disposal of dangerous waste pharmaceuticals. Subsection (a) defers to the DEA’s standards for permitted incinerators as listed in WAC 173-303-555 (7)(b)(i)(A) through (E). Please see WAC 173-303-555 (10) for the full standard.
Nicotine P075 Listing
The adopted regulations implement the EPA’s amended listing for nicotine in WAC 173-303-9903. According to the concise explanatory statement, this change “removes over-the-counter nicotine replacement therapies – including nicotine-containing patches, gums, and lozenges – from being listed as P075 acutely hazardous waste when discarded.” This means that these items are no longer considered dangerous waste and will not count toward the quantities specified in WAC 173-303-170 (10).
- Share this bulletin with the appropriate staff at your hospital.
- Make any changes necessary to your procedures and practices to comply with the adopted standards.
- Subscribe to Ecology’s Dangerous Waste listserv and Shoptalk Newsletter for implementation updates, including specific educational items for health care facilities.
- Contact the Ecology inspector in your region with questions.
WSHA’s 2020 New Law Implementation Guide
Please visit WSHA’s 2020 implementation guide online, where you will find a list of the high priority laws that WSHA is preparing resources and information on to help members implement the new laws, as well as links to resources such as this bulletin. In addition, you will find the Government Affairs team’s schedule for release of upcoming resources on other laws and additional resources for implementation.
The EPA first adopted these dangerous waste regulations at the federal level in August 2019. According to the EPA:
This final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
Washington State adopted the federal regulations to ensure consistency between federal and state regulations, which is a regular practice for Ecology. According to the preliminary regulatory analysis, “Washington State’s health care stakeholders requested that [Ecology] adopt the new federal pharmaceutical waste regulations as soon as possible, in order to help them better manage their waste streams, reduce confusion, and simplify compliance with the dangerous waste regulations. Ecology adopted the standards alongside EPA standards concerning recalled airbags and the Electronic Hazardous Waste Management System. The full package of adopted regulations also contains non-substantive corrections and clarifications throughout Chapter 173-303 WAC.
WA Department of Ecology
Chapter 173-303 WAC– Dangerous Waste Regulations
Environmental Protection Agency
Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.
Drug Enforcement Agency
21 CFR § 1308 – Schedules of Controlled Substances
Department of Transportation
“Transporting Infectious Substances Safely.” Brochure. April 28, 2020.
49 CFR § 171-180 – Hazardous Materials Regulations