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EPA Finalizes Long-Awaited Pharmaceutical Hazardous Waste Rule

Energy, Environment & Natural Resources Alert George J. Marek, Jacqueline M. Vidmar, Lauren R. Grahovac Harpke

As many in the healthcare industry were expecting - and perhaps anxiously awaiting since the rule was initially proposed back in 2015 - the Environmental Protection Agency (EPA) recently published its final Pharmaceutical Hazardous Waste Rule that modifies management standards for hazardous waste pharmaceuticals at healthcare facilities, as well as reverse distributors, and simultaneously amends the acute hazardous waste listing for nicotine. 84 Fed. Reg. 5816 (Feb 22, 2019). Implementation of the new rule, effective August 21, 2019, will require potentially significant evaluation and revision of waste management practices at a large number of impacted facilities, which include pharmaceutical reverse distributors and healthcare facilities (a term broadly defined to include hospitals, clinics, dental practices, long term care facilities, veterinary clinics or hospitals, pharmacies, drug wholesalers, and retail stores that sell pharmaceuticals). Pharmaceutical manufacturers will continue to be regulated under existing Resource Conservation and Recovery Act (RCRA) requirements in 40 CFR Part 262.

In the new Pharmaceutical Hazardous Waste Rule, the EPA strives to create a sector-specific and waste-specific management system for hazardous waste pharmaceuticals under the newly created 40 CFR 266 Subpart P that is better tailored for the unique operational conditions at healthcare facilities and pharmaceutical reverse distributors that made compliance difficult under the traditional cradle-to-grave system in 40 CFR Part 262. In particular, healthcare facilities tend to generate small amounts of many different types of wastes at numerous accumulation points dispersed throughout a large facility. This is in stark contrast to a more typical industrial hazardous waste generator, regulated under Part 262, which usually generates large amounts of only a few predictable hazardous wastes streams at predictable generation points. Additionally, the numerous individuals providing healthcare or pharmaceutical services that could potentially generate pharmaceutical wastes (i.e. nurses or doctors, etc.) are generally not qualified to make knowledgeable hazardous determinations at the point of generation. Again, this differs from a more typical industrial hazardous waste generator, which can usually designate one or two individuals who are familiar with hazardous waste regulations to shoulder this responsibility.

In response, the Pharmaceutical Hazardous Waste Rule pulls healthcare facilities and pharmaceutical reverse distributors that generate pharmaceutical hazardous waste above certain thresholds out of the general Part 262 hazardous waste program and creates a sector-specific hazardous waste management program in Subpart P that is better tailored to pharmaceutical waste generation.

Before considering some of the key aspects of the Pharmaceutical Hazardous Waste Rule, it is important to first consider what will now be regulated as a hazardous waste pharmaceutical. The rule first defines “pharmaceutical,” and then narrows that definition by categorizing what is considered a “hazardous waste pharmaceutical.” Under the new rule, “pharmaceutical” is broadly defined to include any drug or dietary supplement for use by human or other animals; any electronic nicotine delivery system (ENDS), e.g., electronic cigarettes or vaping pens; any liquid nicotine/e-liquid packaged for retail sale for use in ENDS (e.g., pre-filled cartridges or vials). The definition of “pharmaceutical” also includes, but is not limited to, prescription drugs, over-the-counter drugs, dietary supplements, homeopathic drugs, compounded drugs, investigational new drugs, pharmaceuticals remaining in non-empty containers, personal protective equipment (PPE) contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. The definition of “pharmaceutical” does not include dental amalgams, sharps, and medical waste.

Next, the rule then defines “hazardous waste pharmaceutical” as a pharmaceutical that is a solid waste, as defined in 40 CFR Section 261.2, and (1) exhibits one or more characteristics (e.g., toxicity), or (2) is a “listed” solid waste (EPA has an existing list of various listed solid wastes). A pharmaceutical is not a solid waste, as defined in Section 261.2, and therefore is not a hazardous waste pharmaceutical, if it is legitimately used/reused or reclaimed. Also, an over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a solid waste, as defined in Section 261.2, and is therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for its intended purpose), or reclaimed. The rule does not apply to households that discard pharmaceuticals.

By way of example, some of the currently listed pharmaceuticals that are already considered hazardous waste.

P-Listed: (acutely hazardous):  Arsenic trioxide (P012), Physostigmine (P204),  Epinephrine (P042), Physostigimine Salicylate (P188),  Warfarin >0.3% (P001), Phentermine (CIV) (P046)

U-Listed: Chemotherapy drugs, chloroform, phenol, selenium sulfide, cytoxan, mercury

Characteristic hazardous: Humalog, Lantus, Taxol, Atrovent. Flovent, Humulin R, Humulin N.

Below is a summary of certain important components of the new Subpart P under the Pharmaceutical Hazardous Waste Rule:

  • Applicability: The Pharmaceutical Hazardous Waste Rule applies to pharmaceutical hazardous waste generated at healthcare facilities that are large or small quantity generators of hazardous waste, or that generate more than one kilogram of acute hazardous waste, or more than 100 kilograms of non-acute hazardous waste, per month. A healthcare facility's prescription pharmaceuticals moving through reverse distribution must be counted as hazardous wastes if those pharmaceuticals are hazardous by characteristic or are P-listed. Healthcare facilities not meeting this criteria are only subject to certain provisions of Subpart P (sewer disposal prohibition and empty container standards) and may use the optional provisions of Section 266.504.

  • Generator Status: Under Subpart P, a healthcare facility will no longer be classified as a large quantity generator (“LQG”) of hazardous waste after generating more than one kg per month of acute waste pharmaceuticals. Additionally, there are no volume-based generator categories under Subpart P. Instead, all impacted healthcare facilities and all reverse distributors will be regulated in the same way under Subpart P. Non-pharmaceutical hazardous waste generated by these facilities will continue to be regulated under Part 262.
  • Satellite Accumulation: Under Subpart P, a healthcare facility will not be required to comply with satellite accumulation area standards. Satellite accumulation areas are not well suited for the expansive layout and varied operations of healthcare facilities.
  • Accumulation and Segregation: Subpart P expands the allowable time frame for accumulating and storing hazardous waste pharmaceuticals onsite to 365 days without a permit. Additionally, healthcare facilities and reverse distributors are not required to track the monthly generation amounts of hazardous waste pharmaceuticals, or to segregate acute and non-acute hazardous waste pharmaceuticals. However, hazardous waste pharmaceuticals that are prohibited from incineration and subject to land disposal restrictions (i.e., certain waste pharmaceuticals containing metals, mercury or selenium sulfide) must be accumulated in a separate container and labeled as such.
  • Containers and Labeling: Pharmaceutical hazardous wastes must be placed in containers that are structurally sound, compatible with its contents, and that would reasonably prevent spills and leaks. General onsite accumulation containers must be labeled as “Hazardous Waste Pharmaceuticals,” but hazardous wastes codes are generally not required. However, the separate accumulation container for wastes prohibited from incineration and subject to land disposal restriction requirements must be labeled with its applicable hazardous waste codes.
  • Empty Container Standards: Subpart P redefines when a container is considered “empty,” which will make it easier for healthcare-related containers (e.g., syringes, cups, IV bags) to qualify as non-hazardous waste after they are used to administer a pharmaceutical that would be considered hazardous upon disposal.
  • Manifesting: Manifesting requirements for a healthcare facility subject to Subpart P do not require specification of hazardous waste codes.
  • Training: A healthcare facility subject to Subpart P will be required to implement a basic training program for its employees.
  • Sewer Ban: Pharmaceutical hazardous wastes are prohibited from disposal via the sewer system (i.e., via a toilet or drain), which was previously an allowable method of disposal. EPA enacted the sewer disposal ban in response to data showing an increasing presence of pharmaceuticals in our nation’s surface and ground waters.

The Pharmaceutical Hazardous Waste Rule also eliminates potential dual regulation of controlled substances by conditionally exempting controlled substances from most RCRA requirements provided that the facilities comply with the new sewer disposal ban and also with other applicable Drug Enforcement Agency collection, storage, transportation, and disposal requirements.

Finally, EPA is amending the P075 hazardous waste listing for nicotine to exempt over the counter nicotine replacement therapies (NRTs) that are approved by the Food and Drug Administration. Current data shows that today’s newer NRT products contain lower concentrations of nicotine than were contemplated in the original hazardous listing. As a result, today’s approved NRTs do not meet the technical standards for the “acute” designation.

At the federal level, the Pharmaceutical Hazardous Waste Rule will become effective on August 21, 2019, including in Iowa and Alaska which are not authorized to implement state level RCRA programs. In the remaining authorized states, Subpart P and the nicotine amendments will take effect in each state only after the state adopts the final rule. This will result in some state-by-state variability throughout the country. States are required to adopt Subpart P by July 1, 2021, unless statutory amendment is required, in which case the adoption deadline is extended to July 1, 2022. Authorized states may choose if and when to adopt the nicotine amendment as it is considered less stringent than current federal RCRA requirements. The sewer disposal prohibition will become effective in all states starting August 21, 2019.

Wisconsin has already proposed draft rule modifications to incorporate the new Pharmaceutical Hazardous Waste Rule, including the nicotine amendment, and is soliciting comments through May 9, 2019 on the economic impact analysis. Stay tuned for additional updates on adoption and implementation concerns for other states.

For more information, or assistance in understanding the Pharmaceutical Hazardous Waste Rule or its applicability, please contact your Quarles & Brady attorney or: