Published in the February 22, 2019 Federal Register, EPA’s long-awaited final rule to manage hazardous waste pharmaceuticals generated by healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors will go into effect August 21, 2019 in EPA territories and in states that do not have an authorized Resource Conservation and Recovery Act (RCRA) program.
The final rule, entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” provides flexibility from certain hazardous waste requirements, but does requires regulated entities to provide certain training, complete reporting, and maintain recordkeeping, among other obligations. Failure to comply can result in enforcement and potential penalties, so it’s important affected entities to quickly get familiar with the Final Rule and develop a compliance plan.
RCRA-authorized states are required to adopt the final rule; however, the rule’s ban on flushing hazardous waste pharmaceuticals will automatically become effective in all states on August 21, 2019. In addition, because the rule’s exemption from the P075 listing is less stringent than current federal regulations, authorized states may, but are not required to, adopt this change to the P075 listing and can still choose to regulate nicotine replacement therapies (NRTs) as listed waste.
The published rule can be found here.
Rule Provides Healthcare Facilities with Relief
The EPA’s final Management Standards for Hazardous Waste Pharmaceuticals is the Agency’s bridge between the goal of the Resource Conservation and Recovery Act (RCRA) to control the impact of hazardous waste on human health and the environment and the unique circumstances under which hazardous waste is generated by healthcare facilities and reverse distributors.
The difference between healthcare pharmaceutical hazardous waste and the kinds and volumes of hazardous waste generated by industrial facilities (which includes hazardous waste generated by the manufacturers of pharmaceuticals) is so wide that the Agency decided it could not address these wastes under the applicable generator requirements at 40 CFR Part 262. Instead, the final rule establishes an entirely new set of RCRA regulations at 40 CFR Part 266, Subpart P. The intent is to ensure that pharmaceutical hazardous wastes are addressed under RCRA while streamlining requirements to accommodate the management capabilities of healthcare facilities and reverse distributors.
When compared to the Part 262 hazardous waste generator regulations, the streamlined Subpart P requirements are as follows:
- A healthcare facility will not become a large quantity generator (LQG), subject to all the associated requirements, when it generates more than 1 kilogram (kg) of acute hazardous waste pharmaceuticals in a month.
- A healthcare facility will not have to comply with the satellite accumulation area regulations.
- A healthcare facility will not need to specify hazardous waste codes on manifests.
- A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on-site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations.
- A healthcare facility will have basic training requirements.
Furthermore, the final standards are tailored to how reverse distributors operate and, as with healthcare facilities, will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals. Reverse distributors are well-established in the healthcare community and have been used in other regulatory programs. For example, the New York State Department of Environmental Conservation defines a reverse distributor as “a company that receives pharmaceuticals from a wholesale or retail seller or a healthcare facility for the purpose of returning unwanted, unusable, or outdated pharmaceuticals to the manufacturer or the manufacturer’s agent; or where necessary, arranging for processing such substances for disposal.”
Reverse distributors play a critical role in the final management standards.
Partnered with the final management standards is an amendment to the Agency’s RCRA P list of commercial chemical products (CCPs). The amendment removes Federal Drug Administration (FDA)-approved over-the-counter nicotine replacement therapies (i.e., patches, gums, and lozenges) from regulation as a RCRA hazardous waste under Hazardous Waste Code P075 for nicotine. Therefore, under the federal hazardous waste regulations, generators of these wastes (e.g., retail stores) may discard them as nonhazardous waste.
Unique Circumstances
When Congress wrote the hazardous waste provisions of RCRA, it was almost entirely focused on the types of hazardous waste generated by industrial facilities. These wastestreams are well known and relatively few in number. For example, data from the RCRA Biennial Report show that in 2013, approximately 46 percent of LQGs generated between one and five wastestreams. Furthermore, a typical manufacturing facility generates a more predictable set of hazardous wastestreams.
In contrast, a healthcare facility can have thousands of items in its pharmacy at any one time, and these may vary over time based on the needs of the patients. These medications become wastes often at the patient’s bedside, and the generator of the waste is typically the doctor or nurse who administers the medication. As generators, these individuals are required by RCRA to make determinations about whether the waste is a listed hazardous waste or a characteristic hazardous waste. Some pharmaceuticals are P-listed acute hazardous wastes. If the facility generates more than 1 kg of a P-listed waste in a calendar month, it is an LQG subject to the full Part 262 program. The EPA has long recognized that doctors and nurses rarely have the expertise needed to make hazardous waste determinations and moreover believes that they should not be required to do so.
The Agency has also been well aware that the method for managing used or unused pharmaceuticals being employed at healthcare facilities, and particularly at long-term care facilities, is to flush them down the toilet. RCRA, in fact, has permitted such disposal (except for ignitable wastes and wastes that result in toxic fumes within the publicly owned treatment works (POTW)). While most pharmaceutical contamination in the nation’s waters comes from secretions from humans and animals, disposal into sewers is a significant contributor to water pollution and ecological degradation. The rule’s new prohibition on drain disposal of hazardous waste pharmaceuticals is one of the few provisions of the rule that increases compliance obligations. (Another is the elimination of the household hazardous waste exclusion for long-term care facilities.)
These circumstances, each so distinct from the generation and management of industrial hazardous waste, created a clear need for a separate RCRA program.
“Under this final rule, EPA expects that the management of hazardous waste pharmaceuticals will improve and the regulatory burden for many hazardous waste pharmaceutical generators will decrease,” states the Agency. “This final rule provides a solution to many of the issues facing healthcare facilities. By finalizing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA encourages healthcare facilities to manage all of their pharmaceutical waste—non-hazardous and hazardous—under the final rule.”
The final rule goes into effect 6 months from the date it is published in the Federal Register in EPA territories and in states that do not have an authorized RCRA program. That time frame could be longer in authorized states that must first adopt the rule for it to become effective.
Snapshot of Subpart P
All facilities subject to the new subpart are urged to study and implement the provisions well in advance of the effective date that applies to them. Following are selected highlights from the new regulatory language:
- 266.500 Definitions for Subpart P. New RCRA definitions have been added for healthcare facility, long-term care facility, and reverse distributor. Definitions for noncreditable hazardous waste pharmaceutical and potentially creditable hazardous waste pharmaceutical are relevant to the regulatory obligations of reverse distributors.
- 266.501 Applicability. Hazardous waste pharmaceuticals generated or managed by entities other than healthcare facilities and reverse distributors (e.g., pharmaceutical manufacturers) are not subject to the subpart. Pharmaceuticals excluded from regulation under the subpart include pharmaceuticals legitimately used/reused (e.g., lawfully donated for their intended purpose) or reclaimed; over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes; pharmaceuticals being managed in accordance with a recall strategy that has been approved by the Food and Drug Administration; and pharmaceuticals managed in accordance with a recall corrective action plan that has been accepted by the Consumer Product Safety Commission.
- 266.502 Standards for healthcare facilities managing noncreditable hazardous waste pharmaceuticals. Provisions include:
- A healthcare facility must notify the EPA regional administrator, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility operating under Subpart P.
- A healthcare facility must ensure that all personnel that manage noncreditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.
- A healthcare facility must place noncreditable hazardous waste pharmaceuticals in a container that is structurally sound and compatible with its contents and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
- A healthcare facility may accumulate noncreditable hazardous waste pharmaceuticals on-site for 1 year or less without a permit or having interim status.
- Healthcare facilities are not subject to biennial reporting requirements under Section 262.41 with respect to noncreditable hazardous waste pharmaceuticals managed under Subpart P.
- 266.503 Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals. A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical must determine whether the potentially creditable pharmaceutical is a potentially creditable hazardous waste pharmaceutical (i.e., it is listed in 40 CFR Part 261 Subpart D or exhibits a characteristic identified in 40 CFR Part 261 Subpart C). A healthcare facility may choose to manage its potentially creditable nonhazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under Subpart P.
- 266.504 Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and nonpharmaceutical hazardous waste. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and nonpharmaceutical hazardous waste may send its potentially creditable hazardous waste pharmaceuticals to a reverse distributor or to another healthcare facility provided certain conditions are met (e.g., the receiving facility meets relevant Subpart P requirements).
- 266.505 Prohibition on sewering hazardous waste pharmaceuticals. All healthcare facilities—including very small quantity generators—and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a POTW.
- 266.506 Conditional exemption for hazardous waste pharmaceuticals that are also controlled substances and household hazardous waste pharmaceuticals collected in a take-back event or program. To qualify for the exemption, household waste pharmaceuticals must be collected in a take-back event or program, including those that are collected by an authorized collector as defined by the Drug Enforcement Administration.
- 266.507 Residues of hazardous waste pharmaceuticals in empty containers. This section establishes when containers are considered empty of pharmaceuticals. Containers listed under the section include stock, dispensing, and unit-dose containers; syringes; intravenous (IV) bags; and other containers, including delivery devices.
- 266.508 Shipping noncreditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor. A healthcare facility must ship noncreditable hazardous waste pharmaceuticals and a reverse distributor must ship evaluated hazardous waste pharmaceuticals off-site to a designated facility (such as a permitted or interim-status treatment, storage, or disposal facility) in compliance with requirements for packaging, labeling, marking, and placarding. Additional requirements apply to the export and import of noncreditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals.
- 266.509 Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor. A healthcare facility or a reverse distributor that transports or offers for transport potentially creditable hazardous waste pharmaceuticals off-site to a reverse distributor must comply with all applicable U.S. Department of Transportation (DOT) regulations at 49 CFR Parts 171 through 180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR 171.8. For purposes of DOT regulations, a material is considered a hazardous waste if it is subject to the Hazardous Waste Manifest Requirements of the EPA specified at 40 CFR Part 262. Because a potentially creditable hazardous waste pharmaceutical does not require a manifest, it is not considered hazardous waste under DOT regulations.
- 266.510 Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors. A reverse distributor may accept potentially creditable hazardous waste pharmaceuticals from off-site and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a hazardous waste permit or without having interim status provided it complies with specific conditions; these include the requirement to notify the EPA that it is a reverse distributor operating under Subpart P, that it maintains a current inventory of all the potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on-site, and that it accumulates potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for 180 calendar days or less. Other requirements apply to security, contingency plan, and emergency procedures; recordkeeping; and on-site inspections.