On August 31, the Environmental Protection Agency (EPA) released its proposed rule for Management Standards for Hazardous Waste Pharmaceuticals (Proposed Rule) prior to its publication in the Federal Register. The proposal would create a new Subpart P under existing Resource Conservation and Recovery Act (RCRA) regulations exclusively for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. Currently, there are no RCRA regulations that focus specifically on the management of hazardous wastes from hospitals, pharmacies, reverse distributors and other healthcare-related facilities; such facilities are currently required to comply with the same RCRA hazardous waste regulations as many other types of industries that generate wastes.

By issuing this proposed rule, EPA has tentatively decided not to add hazardous waste pharmaceuticals to the existing federal universal waste program, as EPA had initially proposed in 2008. This means that hazardous waste pharmaceuticals may no longer be added as a category of hazardous waste for management under the Universal Waste program, as had previously been done in Michigan and Florida. Because the proposed rule requirements are more stringent than the standards for the Universal Waste program, if the rule is finalized, both states will be required to amend their programs to adopt standards at least as stringent as those in the new Subpart P.

What the Proposed Rule Covers

EPA is proposing an expansive definition of "Pharmaceutical" as:

any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act (FD&C Act), prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with residues of pharmaceuticals, and clean-up material from the spills of pharmaceuticals.

The Rule would govern the management of "Hazardous Waste Pharmaceuticals," which include any pharmaceuticals that are currently listed as a hazardous waste under 40 C.F.R. Part 261, Subpart D, or that have any of the characteristics of hazardous waste listed in in 40 C.F.R. Part 261, Subpart C (ignitability, corrosivity, reactivity, toxicity).

Who It Covers

The Rule as proposed would apply to "healthcare facilities," which include:

hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.

Of note, the definition includes locations that sell pharmaceuticals over the internet, through the mail, or through other types of distribution mechanisms, and also includes entities that engage in drug compounding. It does not include pharmaceutical manufactures and their representative, wholesalers, or any other entity involved in the manufacturing, processing, or wholesale distribution of over-the-counter or prescription pharmaceuticals, unless they meet the definition of a pharmaceutical reverse distributor. These are entities that receive and accumulate potentially hazardous waste pharmaceuticals "for the purpose of facilitating or verifying manufacturer's credit" upon the return of unused and/or expired pharmaceuticals. The EPA's definition of a pharmaceutical reverse distributor is different than and broader in scope than the definition of that term as used by the Drug Enforcement Administration.

EPA is proposing that a healthcare facility that is currently considered either a traditional large quantity generator (LGQ) or a small quantity generator (SQG) be subject to Subpart P if it generates (or accumulates) more than 100 kg of hazardous waste per month or more than one (1) kg of acute hazardous waste per month. An acute hazardous waste is generally, but not necessarily solely, any P-listed hazardous waste. A healthcare facility that is currently considered to be a conditionally exempt small-quantity generator (CESQG) (generates less than or equal to 100 kg of hazardous waste, and less than or equal to 1 kg of acutely hazardous waste) will be able to maintain its conditional exemption under 40 C.F.R. § 261.5 and will not be subject to most aspects of the proposed rule. However, EPA is proposing a ban on sewer disposal of hazardous waste pharmaceuticals by all healthcare facilities, including CESQG facilities. Additionally, currently, CESQG facilities are limited in where they may send their hazardous wastes for treatment and disposal; the rule proposes to allow CESQG healthcare facilities to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor.

Requirements under the Proposed Rule

The applicable handling and disposal requirements would depend upon whether the hazardous waste pharmaceutical is eligible for a manufacturer's credit. If it is not eligible, it "must be transported as hazardous waste, including the use of the hazardous waste manifest, and sent to a RCRA interim status or permitted facility." However, the Rule as proposed would allow creditable hazardous waste pharmaceuticals to be shipped to pharmaceutical reverse distributors for processing of the manufacturer's credit.

New Subpart P would contain separate requirements for healthcare facilities and reverse distribution facilities. Healthcare facilities would be responsible for, among other requirements:

  • Training employees to be "thoroughly familiar with proper waste handling and emergency procedures";
  • Maintaining inventories of non-creditable hazardous waste pharmaceuticals;
  • Disposing of hazardous waste pharmaceuticals within one year; and
  • Preventing disposal of hazardous waste pharmaceuticals into a sewer system.

Reverse distribution facilities would be allowed to accept and accumulate potentially creditable hazardous waste pharmaceuticals without a permit, provided that they comply with the requirements of new Subpart P. These requirements include, but are not limited to:

  • Complying with specific packaging, labeling, and marking requirements;
  • Maintaining an inventory of all potentially creditable hazardous waste pharmaceuticals;
  • Creating and enforcing minimum security requirements; and
  • Properly disposing of the potentially creditable hazardous waste pharmaceuticals within 90 days.

EPA will accept comments on the Proposed Rule for 60 days following its publication in the Federal Register. Venable's attorneys are experienced in advising stakeholders on issues regarding the handling, storage, and disposal of hazardous wastes, and on how this proposed rule may affect their current operations. For more information on how the Proposed RCRA Subpart P may affect your business, and for assistance in commenting on the proposed rule, please contact the authors of this alert.