1. Small and Large Quantity Generators (SQG and LQGs) that meet the EPA’s new definition of a health care facility or reverse distributor must manage their hazardous waste pharmaceuticals under new subpart P. 2. Very Small Quantity Generators (VSQGs) that meet the EPA’s new definition of health care facility or reverse distributor have the option of managing hazardous waste pharmaceuticals under new subpart P. 3. Facilities have less stringent options to dispose of containers with residual hazardous waste and p-listed wastes. 4. Controlled substances that are hazardous waste are conditionally exempted from being managed as such.

The rule is intended to provide health care specific regulations for the management of hazardous waste pharmaceuticals and help keep pharmaceuticals from entering our waterways. These tailored standards strive to make it easier and safer for health care facilities to follow, rather than the industrial-oriented hazardous waste generator regulations.

As defined in the final rule, the new regulations cover most health care entities that manage pharmaceutical products and waste such as hospitals, pharmacies, dentists, nursing facilities or long-term care facilities (LTCF), clinics and reverse distributors. The final rule does not apply to pharmaceutical manufacturers (unless they act as reverse distributors) or production facilities.

Under the new Final Rule, pharmaceutical waste (including P-listed wastes) does not count toward generator status. Hazardous waste from other areas of health care facilities and reverse distributors, such as solvents and other nonpharmaceutical waste, (e.g., products and other retail waste) will still be used to determine generator status.

The Final Rule bans the flushing (also called “sewering”) of all hazardous waste pharmaceuticals, regardless of generator type. This ban does not affect nonhazardous pharmaceuticals. However, the EPA discourages flushing of any pharmaceuticals. See WM’s infographic on the effects pharmaceutical waste has on the environment.

There are only a few controlled substances that are hazardous waste. These few drugs are conditionally exempted from hazardous waste regulations when managed in compliance with DEA regulations and incinerated at an authorized facility.

1. Stock, dispensing, and unit dose containers — this includes vials, blister packs, and dispensing bottles (not to exceed 1 liter or 10,000 pills). These items are considered empty when their contents have been removed by normal means and are not regulated as hazardous waste, even if they held P-listed wastes.

2. Syringes — syringes are considered empty and not regulated as hazardous waste pharmaceuticals when the plunger has been fully depressed. The empty syringe should be managed under applicable federal, state, and local requirements for medical waste and sharps.

3. Intravenous bags (IVs) — fully administered IV bags are considered empty and/or those that meet the current definition of RCRA empty.

4. Other containers, including delivery devices — this includes items such as inhalers, nebulizers, ointments, gels, and creams. These items are also considered empty when the current definition of RCRA empty is met.

Yes. The EPA amended the current listing for acutely hazardous nicotine and salts (P075) designating that FDA-approved, over-the-counter nicotine replacement therapies such as patches, gums and lozenges are no longer considered acutely hazardous waste.

This new exception applies to all generators of hazardous waste, not just healthcare facilities as it is outside of subpart P. Other nicotine containing products such as prescription replacement therapies and e-cigarettes are not excluded from the P075 listing and are still regulated as such. There is no requirement or timeline for state adoption.

Stay aware of your state's progress and potentially unique adoption of the Final Rule. It is very important to understand that all current RCRA regulations are being enforced until your state adopts. It is recommended that facilities potentially impacted by the Final Rule review the regulations.

The USP does not enforce regulations. However, USP’s drug standards do influence and can be adopted by regulatory bodies including the Food and Drug Administration (FDA), state pharmacy boards and accrediting agencies such as Joint Commission.

WM monitors all federal and state regulations affecting your regulated waste management. If WM is servicing your facilities’ pharmaceutical waste and you are following the WM Waste Acceptance Policy, you are compliant with waste management regulations and current USP 800

standards concerning disposal. Be aware:

• USP 800 is not a new set of regulations concerning pharmaceutical waste but rather new protocols for safe handling of pharmaceuticals in the clinical or pharmaceutical workplace.

• Pharmaceutical waste will continue to be handled in accordance with EPA requirements, NIOSH guidelines, and individual state regulations.

• WM strives to ensure our customers stay OSHA compliant, including with OSHA’s Hazard Communication Standard

For the safety of your employees and to stay compliant with the OSHA Hazard Communication Standard, you must keep an updated Hazard Communication Program (HCP). The USP 800 recommends only two additions: A written plan that describes how the USP 800 standard will be implemented and a provision that personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs. Among other rules of the Hazard

Communication Standard, your HCP still needs to include:

• All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings

• Entities must have an safety data sheet (SDS) for each hazardous chemical they use (29 CFR 1910.1200)

• Entities must ensure that the SDSs for each hazardous chemical used are readily accessible to personnel during each work shift and when they are in their work areas

• Personnel who may be exposed to hazardous chemicals when working must be provided information and training before the initial assignment to work with a hazardous chemical, and also whenever the hazard changes.

USP 800 states that “handling hazardous drugs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal.” USP 800 refers primarily to transport and disposal within the healthcare facility but the standard does reflect WM’s long-standing recommendations as well as our Waste Acceptance Policy regarding hazardous drug wastage generated from chemotherapy.

Transport <800>, 11.3

“Hazardous drugs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. HDs must be transported in containers that minimize the risk of breakage or leakage. Pneumatic tubes must not be used to transport any liquid hazardous drugs or any antineoplastic hazardous drugs because of the potential for breakage and contamination. When shipping hazardous drugs to locations outside the entity, the entity must consult the Transport Information on the SDS. The entity must ensure that labels and accessory labeling for the hazardous drugs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier’s policies.”

Disposal <800>, 11.4

“All personnel who perform routine custodial waste removal and cleaning activities in HD handling areas must be trained in appropriate procedures to protect themselves and the environment to prevent hazardous drug contamination. disposal of all hazardous drug waste, including, but not limited to, unused HDs and trace-contaminated PPE and other materials, must comply with all applicable federal, state, and local regulations.” Note: Disposal of all HD waste (including unused and unusable HDs) must comply with all applicable federal, state, and local regulations. Because USP 800 is not a regulation, and USP does not have jurisdiction over waste disposal, the standard defers to federal, state, and local regulations for waste disposal. This means that EPA regulations need to be followed for hazardous drug disposal that are also hazardous wastes. Some states also regulate waste that previously contained HDs or was used to administer HDs, in those states’ regulated medical waste regulations; this waste is often referred to as “trace chemotherapy” waste.

The HWGIR focuses on generators of hazardous waste; all three categories of hazardous waste generator will be affected. All generators of hazardous waste will be required to review their waste streams to make an “accurate” waste determination to identify if their wastes are characteristically hazardous or falls in one of the listed categories of waste.

There will remain three categories of generators and the quantities qualifying generators into these categories remain the same: Large Quantity Generator (LQG), Small Quantity Generator (SQG), and Very Small Quantity Generator (VSQG), which replaces the former term Conditionally Exempt Small Quantity Generator (CESQG). A generator must determine which category they belong to based on the amount of waste generated in a calendar month, the amounts do not differ from prior regulations. The proposed rule reorganizes these regulations and makes them easier to find and follow.

The section of regulations pertaining to a generator making hazardous waste determinations was expanded and revised. Emphasis was placed on the generator accurately determining if their solid waste is also a hazardous waste. SQGs and LQGs must document and maintain records of such determinations. These records must be kept for 3 years from the date the waste was last generated.

Under the HWGIR, SQGs and LQGs can accumulate as much as 55 gallons of non-acute hazardous waste and/or one quart of acute hazardous waste at or near the point of generation. The addition of “and/” is new and significant. The rules for container requirements did not change (closed, compatible with waste inside, in good condition) however additional requirements were added about incompatible wastes. Incompatible waste cannot be collected in the same container or in a container that previously held an incompatible waste or material, unless there is no chance of a reaction.

A container in an SAA must still be marked with the words “Hazardous Waste” but additional requirements were added. A container must also be marked with other words that provide an indication of the hazards of the contents; the waste characteristic, DOT labels and OSHA pictograms are given as examples.

Wastes that reach the accumulation amount limits in a SAA must be moved within three consecutive days of reaching their limit (and be marked with the date it reached the limit).

The term “Central Accumulation Area” or “CAA” was defined in the HWGIR; this area was previously noted as the 90- or 180-day accumulation area. Currently, both SQGs and LQGs are to inspect this area weekly. The indication of hazard labeling and marking noted above in the SAA section will also be required in the CAA.

A VSQG and SQG can take advantage of a new subpart, subpart L, to manage wastes in excess of their monthly generation limits without becoming subject to waste generation rules for a higher generation category. Only one episodic event is allowed per year, but a generator can petition the EPA for one additional event per year if that event is unplanned.

In order to comply, the generator must have an EPA ID number. At least 30 days prior to the event (or within 72 hours in the case of an unplanned emergency), the generator must notify EPA of the event. Waste can be collected in containers that must be in good condition, kept closed except to add or remove waste, and are compatible with the contents. Containers must also be marked with the words “Episodic Hazardous Waste”, an indication of hazards of the contents (ie. Waste characteristic, OSHA pictograms, DOT labels) and the date the event began.

The generator has 60 days to complete the episodic event, unless an extension is granted. Records of the event must kept for 3 years and include the following: beginning and end dates of the event, a description of the event, types and quantities of waste generated, a description of how the waste was managed and name of the facility that received it, name of the transporter, hazardous waste manifests and approval letters for the event from EPA.

Before transporting or offering a container for transport, an SQG or LQG must mark each container with all applicable waste codes. Generators can also use a nationally recognized electronic system such as bar coding to identify the EPA hazardous waste codes. Lab packs remain as they are required to be managed today.

The proposed rule requires both SQGs and LQGs to re-notify the EPA of their hazardous waste activities.. An SQG must re-notify starting in 2021 and then every four (4) years thereafter. LQGs must do so by March 1 of even-numbered years as part of their biennial report. This is done using form 8700-12, which has been revised to add this additional notification section and can be submitted as part of the Biennial Report.

New LQGs must have a quick reference guide for emergency responders. The SAA and CAA must be included as part of the emergency procedures. While LQGs must follow Subpart M – Preparedness, Prevention and Emergency Procedures, SQGs are not required to develop plans (there are still some emergency procedures that must be followed).

An LQG must notify the EPA 30 days prior to closing a unit, or place a note in their facility operating record; this also applies to the CAA but not SAAs. If the generator is closing the site, they must notify EPA within 90 days of completing the closure. Closure as a landfill is required if the facility fails to clean close.

The HWGIR allows a VSQG to ship their hazardous waste to an LQG that is under the control of the same person. VSQGs are generally not required to label their containers, but would need to comply with stricter labeling requirements when shipping waste to an LQG location. The LQG would need to notify the EPA 30 days prior to receiving the shipment via the 8700-12 form. The containers received must be labeled with the date they were received, the 90-day accumulation limit clock starts on this day. Records of shipments received including name, address and contact information for the VSQG, quantities and types received from VSQG must be kept by the LQG for 3 years. While no manifests are required when a VSQG ships to a LQG, the LQG are required to manage the waste as part of their waste stream and have all appropriate information prior to shipping off site for disposal.