The new hazardous waste pharmaceutical management standards established by EPA’s Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (“Rule”) are already effective in some states. Other states must adopt the rule by July 1, 2021 or, if a statutory amendment is required prior to the state’s adoption, by July 1, 2022. Based on this, all “healthcare facilities”[1] and “reverse distributors,”[2] as defined by the Rule, will ultimately be required to comply with the Rule (as adopted in each state).

In many cases, it is obvious that a certain facility meets the Rule’s definition of healthcare facility or reverse distributor; in other cases, it may not be as obvious. For example, although pharmaceutical manufacturers are specifically excluded from the definition of “healthcare facility,” a pharmaceutical manufacturer may well meet the definition of a “reverse distributor,” in which case the manufacturer must comply with the Rule. The definition of “reverse distributor” specifically indicates that any pharmaceutical manufacturer “that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.”

Here we focus on the Rule’s prohibition against healthcare facilities sending unauthorized waste to reverse distributors and the Rule’s requirement that reverse distributors submit unauthorized waste reports detailing unauthorized waste received. 40 C.F.R. § 266.510(a)(9). These notification requirements present several questions and concerns for both reverse distributors receiving the waste and healthcare facilities sending the waste. These considerations should be motivators for healthcare facilities to ensure they only provide potentially creditable hazardous waste pharmaceuticals to reverse distributors. Otherwise, the reverse distributor is (or will be in the future) forced to report the unauthorized waste directly to either EPA or the State. Below we discuss several issues that are likely on the minds of both reverse distributors and healthcare facilities.

  1. What does the Rule mean by “unauthorized waste”? Does this include all pharmaceuticals that don’t ultimately receive credit? A pharmaceutical is not an “unauthorized waste” simply because it does not ultimately receive manufacturer credit. So long as a pharmaceutical meets the Rule’s definition of “potentially creditable hazardous waste pharmaceutical,”[3] the Rule allows healthcare facilities to send the material to a reverse distributor. Instead, unauthorized waste includes material that the reverse distributor is not authorized to receive, such as non-pharmaceutical hazardous waste and regulated medical waste. EPA notes in the Rule’s preamble that patient care waste (e.g., IV bags and tubing), contaminated personal protective equipment (PPE), medical waste, or other inappropriate wastes” are also examples of unauthorized waste. 84 Fed. Reg. 5924 (Feb. 22, 2019).
  1. What must a reverse distributor include in the unauthorized waste report? The Rule gives specific details about what information must be reported. 40 C.F.R. § 266.510(a)(9). Reverse distributors must include the following in each unauthorized waste report:
    1. the reverse distributor’s EPA ID number;
    2. the date the reverse distributor received the unauthorized waste;
    3. the EPA ID number of the healthcare facility that shipped the unauthorized waste, if available;
    4. a description and the quantity of each unauthorized waste, if available;
    5. the method of treatment, storage, or disposal for each unauthorized waste; and
    6. a brief explanation of why the waste was unauthorized, if known.
  1. When must reverse distributors begin sending these unauthorized waste reports, and where do reverse distributors send them? Based on the Rule, a reverse distributor must send the unauthorized waste report to EPA or the authorized state agency within 45 days of receiving the shipment. 40 C.F.R. § 266.510(a)(9).[4] Except for Alaska and Iowa, states are authorized to run their own RCRA programs, which means that in those states, reverse distributors must send the unauthorized waste report to the state agency, not to EPA.

Importantly, whether the rule is effective in a given state is key in determining whether a reverse distributor is currently required to prepare and send unauthorized waste reports. While all states are required to adopt the regulation eventually – by July 1, 2021 or, if a statutory change is required, by July 1, 2022 – there is no requirement to submit the unauthorized waste report to the state agency or the healthcare facility that sent the unauthorized waste until the state adopts the Rule. Reverse distributors in Alaska and Iowa, to the extent there are reverse distributors in those states, are already required to submit unauthorized waste reports to EPA, since EPA administers the RCRA programs in those states, and thus the requirements were effective in those states on August 21, 2019. Likewise, any reverse distributors in states that have already adopted the Rule are required to submit unauthorized waste reports to the state agency.

In short, in many states, reverse distributors are not currently required to submit unauthorized waste reports to their state environmental agency or to healthcare facilities that sent the unauthorized waste. Because all states must eventually adopt the Rule, all reverse distributors will eventually be required to submit these unauthorized waste reports.

  1. Aside from reporting unauthorized waste, what must a reverse distributor do with unauthorized waste? The Rule requires that reverse distributors manage any unauthorized waste in accordance with all applicable regulations. EPA noted in the Rule’s preamble that “[h]ealthcare facilities are not equipped as well as reverse distributors to manage the hazardous waste and EPA is concerned that rejecting shipments of non-creditable hazardous waste will prolong mismanagement.” 84 Fed. Reg. 5925.

For additional information on the Rule, please contact Karlie Webb, Greg Blount, and Morgan Gerard of Troutman Sanders LLP.

[1] The Rule defines “healthcare facility” as any person that is lawfully authorized to

(1) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or

(2) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.

40 C.F.R. § 266.500

[2] The Rule defines “reverse distributor” as “any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.” 40 C.F.R. § 266.500

[3] “Potentially creditable hazardous waste pharmaceutical” means:

a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and is (1) In original manufacturer packaging (except pharmaceuticals that were subject to a recall); (2) Undispensed; and (3) Unexpired or less than one year past expiration date. The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements.

40 C.F.R. § 266.500

[4] As an additional concern, it is unclear whether the unauthorized waste reports may be publicly available through EPA’s and/or the particular state’s document databases.