Health Law Monitor

By: James W. Thomas

Introduction

On September 25, 2015, the United States Environmental Protection Agency (“EPA”) proposed a rule to address the management and disposal of hazardous waste pharmaceuticals at healthcare facilities. The proposed rule seeks to do the following:

• Ban all drain disposal of hazardous waste pharmaceuticals at hospitals, pharmacies, clinics, dentists, and long-term care facilities
• Clarify that many long-term care facilities will no longer benefit from RCRA’s “household waste exclusion” and therefore will be treated like hospitals rather than households for purposes of hazardous waste generation
• Simplify the process for healthcare facilities to accumulate and ship hazardous waste pharmaceuticals
• Exempt certain unused pharmaceuticals returned to manufacturer from classification as hazardous waste  
• Reduce dual regulation of hazardous waste pharmaceuticals that are also DEA controlled substances or medical waste

Interested parties will have until November 24, 2015 to comment on the proposed rule. If you would like to evaluate the proposed rule’s impact on your healthcare facility or are interested in submitting rulemaking comments, please contact James W. Thomas and Aaron Heishman, Jackson Kelly PLLC.

Healthcare Facilities Affected

EPA’s proposed rule would impact an estimated 174,000 healthcare facilities in the U.S. from the following categories:

Existing Regulatory Background For The Disposal Of Hazardous Waste Pharmaceuticals At Healthcare Facilities

The Resource Conservation and Recovery Act (“RCRA”) governs the generation, storage, transportation, and disposal of solid waste and hazardous waste. All healthcare facilities generate pharmaceutical waste, including expired medicines and residue in used syringes and IV bags. While most pharmaceutical waste is not hazardous waste, healthcare facilities generate approximately 36,200 tons of hazardous waste pharmaceuticals annually. Common hazardous waste pharmaceuticals includes used smoking cessation patches containing nicotine and drugs containing warfarin such as the blood-thinning medication Coumadin®.

Properly managing and disposing of hazardous waste pharmaceuticals presents a challenge to healthcare facilities. RCRA was designed for large manufacturing facilities with employees dedicated to handling predictable waste streams. Healthcare facilities, on the other hand, generate small quantities of waste throughout a facility and require waste determinations to be made by employees whose first priority is to care for patients. Environmental agencies in many states have taken notice of the struggle of healthcare facilities to properly dispose of hazardous waste pharmaceuticals, and have brought enforcement actions against healthcare facilities for RCRA violations in recent years.  

Categories of Hazardous Waste Generators

Currently, healthcare facilities that generate hazardous waste are divided into three categories—Large Quantity Generators (“LQGs”), Small Quantity Generators (“SQGs”), and Conditionally Exempt Small Quantity Generators (“CESQGs”) based on the quantity of hazardous waste generated per month. CESQGs are subject to fewer regulations, and may send hazardous waste to solid waste landfills rather than regulated hazardous waste treatment, storage, and disposal (“TSD”) facilities.

Hazardous Waste Pharmaceuticals Will Not Count Toward Generator Status

Hazardous waste pharmaceuticals managed in compliance with EPA’s proposed rule will no longer count toward a generator’s status. For example, a hospital that currently generates 110 kg of hazardous waste per month, of which 20 kg is hazardous waste pharmaceuticals, would only be deemed to be generating 90 kg of hazardous waste per month under the proposed rule. Therefore, the hospital could change from a SQG to a CESQG and be subject to fewer regulations. EPA predicts the proposed rule will allow many healthcare facilities to downwardly adjust their hazardous waste generator status.

Treatment of Unopened Pharmaceuticals Returned To Manufacturers For Credit

Often, healthcare facilities return unused pharmaceuticals to manufacturers for credit that can be used to offset the cost of future purchases. Under EPA’s proposed rule, a healthcare facility’s generator status will not be affected by quantities of pharmaceuticals that are returned to manufacturers or reverse distributors for credit. 

Waste Exemption for DEA Controlled Pharmaceuticals

Some pharmaceuticals, such as phenol, are simultaneously listed as a hazardous substance by EPA and as a Controlled Substance by the Drug Enforcement Agency (“DEA”). Healthcare facilities that generate this dual waste face the expensive task of complying with both RCRA and DEA regulations. EPA proposes to conditionally exempt from RCRA regulation any hazardous waste pharmaceutical that is also a DEA controlled substance, as long as the healthcare facility complies with all DEA regulations.

Prohibition On Sewer Disposal of Hazardous Waste Pharmaceuticals

EPA is proposing to ban all healthcare facilities, including CESQGs, from disposing hazardous waste pharmaceuticals into sewers through sinks, toilets, and drains. EPA claims sewer disposal of pharmaceuticals affects human health and the environment.  

Removal of Household Waste Exclusion for Long-Term Care Facilities

Hazardous substances that are generated in residential households are largely exempted from hazardous waste disposal regulations due to the “Household Waste Exclusion.”[1] Currently, all hazardous waste—including hazardous waste pharmaceuticals—generated by patients at long-term care facilities is treated as exempted household waste. In its proposed rulemaking, EPA expresses its intent to abolish this household waste exemption for many long-term care facilities.

It must be stressed that EPA seeks to remove this household waste exemption for all hazardous waste generated at long-term care facilities, not just for hazardous waste pharmaceuticals. EPA believes long-term care facilities should be treated like hospitals rather than households. If adopted, this proposal could cause many long-term care facilities to become SQGs or LQGs for the first time due to the amount of non-pharmaceutical hazardous waste they generate. Importantly, the proposed rule clarifies that the household waste exclusion would continue to apply to group homes and independent living communities.

Treatment of Hazardous Waste Pharmaceutical Residue

An empty container that held hazardous waste pharmaceuticals can be treated as non-hazardous waste if it is “RCRA empty.” Currently, containers that once held acute hazardous waste must be triple rinsed to be RCRA empty, while the residue in containers that held non-acute hazardous waste must weigh less than 0.3 percent by weight of the container’s capacity.[2] To simplify this determination, EPA proposes the following rules:

            Unit-Dose Containers – Packets, pill cups, blister packs, bottles, and vials holding up to 1 liter of liquid or 1,000 pills will be considered RCRA empty if the pharmaceuticals have been fully dispensed. 

            Dispensed Syringes – Used syringes that held hazardous waste pharmaceuticals are also medical waste. Currently, these dual wastes must be managed, at considerable cost, in compliance with both RCRA and medical waste regulations. EPA proposes to exclude from RCRA regulation syringes that contain residue of hazardous waste pharmaceuticals. Instead, dispensed syringes can be disposed of as medical waste.

            Other Containers – EPA proposes to regulate containers with residue of hazardous waste pharmaceuticals (e.g., IV bags and tubing, inhalers, aerosols, medicine tubes) as hazardous waste if the residues contain listed hazardous wastes or exhibit a hazardous waste characteristic for ignitability, reactivity, corrosivity, or toxicity. 

Additional Standards for Healthcare Facilities Generating Hazardous Waste Pharmaceuticals

Under EPA’s proposal, healthcare facilities that generate hazardous waste pharmaceuticals that do not quality as CESQGs would be subject to the following rules:

          Personnel Training – Healthcare facilities must inform employees that handle hazardous waste pharmaceuticals regarding the proper handling and disposal of these wastes. Training can be administered verbally or through written materials.

          Hazardous Waste Manifest Identifications – Currently, healthcare facilities that ship hazardous waste pharmaceuticals for disposal must assign the containers specific waste codes. EPA proposes to eliminate this requirement and instead allow healthcare facilities to simply mark containers “hazardous waste pharmaceuticals.”

          Longer Accumulation Time – LWQs and SQGs are currently only allowed to accumulate hazardous wastes for limited periods of time. The need for frequent shipments is not cost effective for healthcare facilities that generate large quantities of waste. EPA proposes to allow healthcare facilities to accumulate hazardous waste pharmaceuticals for up to 1 year before they must be shipped to a disposal facility.

This article was authored by Aaron Heishman, Jackson Kelly PLLC.