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EPA Finalizes Universal Waste Rule for Hazardous Aerosol Can Wastes, Streamlining Requirements for Their Management

Written by Aaron H. Goldberg, Principal, Beveridge & Diamond

On November 15, 2019, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a final rule to classify and regulate hazardous aerosol can wastes as “universal wastes” under the federal Resource Conservation and Recovery Act (RCRA) hazardous waste rules. Once the rule becomes effective, hazardous aerosol can wastes will be subject to substantially reduced requirements for collection and transport, in order to facilitate and encourage environmentally sound recycling or disposal. However, the ultimate recycling and disposal facilities will remain subject to essentially the same requirements as currently apply. As discussed below, even though the final rule is largely consistent with existing requirements for other universal wastes, and even though EPA has finalized the proposal with only limited changes, there are several aspects of the rule that warrant special attention.

The final rule builds on existing universal waste requirements for other ubiquitous hazardous wastes, such as batteries, lamps, mercury-containing equipment, and certain pesticides. See generally 40 C.F.R. Part 273. Among other things, the aerosol can wastes will no longer have to be labeled as hazardous wastes (although they will be subject to reduced marking requirements), they may be stored for up to one year or even longer in some cases (rather than just 90 days for large quantity generators), they may be transported offsite without a hazardous waste transporter or hazardous waste manifest, and collection facilities not engaged in treatment or disposal will not have to be permitted as hazardous waste storage facilities. In addition, only large handlers of universal wastes (e.g., facilities that accumulate 5000 kg or more of total universal wastes at any time) will be required to notify EPA and track shipments of the hazardous aerosol can wastes. Aerosol can wastes generated by households and Very Small Quantity Generators (VSQGs) meeting applicable requirements will remain exempt from the RCRA regulations. However, all aerosol wastes will remain subject to applicable requirements under the U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR) (although under those rules, if aerosol cans are classified as universal wastes, they will not be subject to the enhanced DOT requirements that normally apply to RCRA hazardous wastes). See 49 C.F.R. § 171.8 (defining “hazardous wastes” for purposes of the HMR as materials subject to federal hazardous waste manifest requirements).

Several key aspects of the final rule are discussed below. We note that the discussion here is based solely on the pre-publication version of the final rule and preamble. It is possible (though unlikely) that there may be some substantive changes in the rule when it is published in the Federal Register. In addition, EPA’s Response-to-Comments document and economic assessment for the rule (neither of which are currently publicly available) may provide a further gloss on some of the issues addressed here.

Definition of Aerosol Can

The proposed rule would have limited the definition of “aerosol cans” subject to the rule to containers that use gas to “aerate and dispense any material … in the form of a spray or foam.” In this way, the proposal would have excluded cans that dispense products without aeration (e.g., shaving gels) and cans that release only gas (e.g., spray dusters or aerosol horns). In response to comments, EPA modified the definition in the final rule so that it is more inclusive and consistent with DOT rules. Under the final rule, cans that dispense products without aeration will be eligible for management as universal wastes. However, gas-only products will be excluded. DOT is currently considering a petition to revise its definition to include these products, consistent with international rules for dangerous goods transport. See Petition of the Consumer Specialty Products Association, et al. to DOT (September 28, 2017). Unfortunately, the preamble to EPA’s final rule does not mention this petition, and it is unclear if the Agency would amend the definition in the universal waste rule if/when DOT changes its definition.

Status of Aerosol Cans with Evidence of Leakage/Damage

The proposed rule would have excluded from the scope of the universal waste rule any aerosol cans that “show evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.” Commenters expressed concern that this proposed limitation was highly ambiguous, could effectively eviscerate the rule and was unnecessary from an environmental perspective (since EPA could simply require more protective packaging for leaking aerosol cans). In the final rule, the Agency agreed with the commenters and added new provisions specifying that “[u]niversal waste aerosol cans that show evidence of leakage must be packaged in a separate closed container or overpacked with absorbents, or immediately punctured and drained.” EPA also modified the definition of aerosol can so that it no longer requires that cans be “intact” to be classified as universal wastes.

Status of Empty Aerosol Cans

The final rule, like the proposed rule, excludes aerosol cans that meet the regulatory definition of an empty container. This exclusion raises a number of issues, as discussed below:

  • Commenters on the proposed rule asked EPA for clarification about when aerosol cans are properly deemed empty. They noted that it is unclear how the regulatory definition of empty and related Agency guidance applies to aerosol cans. EPA largely side-stepped this issue in the final rule. It merely restated the regulations and guidance and said that further clarifications or modifications to the relevant rules were outside the scope of the rulemaking.
  • Commenters raised questions about the relationship of the exclusion for empty cans with past EPA statements that such cans may sometimes exhibit the characteristic of reactivity. See EPA, RCRA Hotline Report (September 1987) (RCRA Online #13027) (“Irrespective of the lack of contained waste, [empty] aerosol cans would be a RCRA hazardous waste [to the extent] they demonstrate the hazardous characteristic of reactivity”). Neither the final rule nor the preamble addresses this issue.
  • The proposal left open the question as to whether empty cans could voluntarily be managed as universal wastes. In the preamble to the final rule, EPA clarified that empty cans may be managed as universal wastes, even though they do not have to be.

Other Issues Related to the Applicability of RCRA to Aerosol Cans

Commenters on the proposed rule asked EPA for guidance on several fundamental issues associated with the applicability of RCRA to aerosol cans in the first instance. For example, they requested guidance on the extent (if any) to which aerosol cans destined for recycling are properly classified as solid wastes (and thus potentially hazardous wastes). The commenters also asked the Agency for guidance about when (if ever) waste aerosol cans (empty or non-empty) might be classified as reactive hazardous wastes, and (as noted above) when aerosols cans qualify as empty. However, the final rule and preamble are essentially silent on these issues. Moreover, even though EPA had previously committed to providing such guidance as part of its 2016 strategy for addressing the applicability of RCRA to the retail sector, the preamble to the final rule states that “EPA has [now] completed all commitments made in the Retail Strategy,” which suggests that the guidance may not be forthcoming. See EPA, “Strategy for Addressing the Retail Sector under the Resource Conservation and Recovery Act’s Regulatory Framework” (September 12, 2016) at 6 (“EPA is developing a guide on how to recycle aerosol cans under the existing Subtitle C recycling exclusions”).

Allowance of Certain Processing Activities by Handlers

The final rule allows handlers of universal waste aerosol cans to perform certain limited activities, “as long as each individual aerosol can is not breached and remains intact”:

  • Sorting aerosol cans by type.
  • Mixing intact cans in one container.
  • Removing actuators to reduce the risk of accidental release.

Although there may be some uncertainty, it appears that these activities may only be performed with intact containers, even though (as noted above) EPA has modified the definition of aerosol can to eliminate the “intact” requirement. For these purposes, it appears that a can with a removed (or possibly missing) actuator would still be viewed as intact, assuming the integrity of the can has not otherwise been compromised.

Special Rules for Puncturing and Draining of Aerosol Cans

Even though puncturing and draining of hazardous aerosol cans is currently exempt from RCRA regulation if performed as part of a recycling process, the final rule imposes new requirements for puncturing and draining by handlers of universal waste aerosol cans (whether they are processing their own aerosol can wastes or those generated by others). For example, these activities will have to be performed using a device (commercial or “homemade”) that is specifically designed to do so in a safe manner that effectively contains residual contents and emissions. The handler will have to develop and follow written procedures to ensure proper operation of the equipment (including segregating incompatible wastes and preventing fires/releases) and to respond to any spills or releases, and it will have to ensure relevant employees are adequately trained. The contents drained from the aerosol cans will have to be “immediately” transferred to a tank or container meeting applicable hazardous waste generator requirements (e.g., the requirements for 90-day accumulation units or satellite accumulation units). A hazardous waste determination will have to be performed on the drained contents, and the materials will have to be managed accordingly. The drained cans will have to be recycled, and since they will be eligible for the RCRA exemption for recycled scrap metal, they will not have to be subjected to a hazardous waste determination. EPA notes that all of these activities must be conducted in compliance with all applicable federal, state, and local laws and regulations related to solid or hazardous wastes, as well as occupational safety and health.

Adoption by the States

EPA states that the final rule is “less stringent than the current federal program” and thus “states … will not have to adopt the universal waste regulations for aerosol cans.” However, as noted above, the new rules for puncturing and draining are more stringent than current rules (because those activities are currently exempt from regulation if performed as part of a recycling process), which casts doubt on the Agency’s claim that the final rule (in its entirety) is less stringent.

Shipments Between States

Despite requests from commenters for EPA to address this issue, the final rule and preamble are silent on the requirements that will apply to aerosol cans shipped from, to, or through states that do not adopt (or have not yet adopted) a universal waste rule for aerosols. In prior universal waste rules for other wastes, EPA has claimed that, in such circumstances, the waste would have to be transported in the non-universal-waste states by a hazardous waste transporter and with a hazardous waste manifest. See, e.g., 64 Fed. Reg. 36,466, 34,483 (July 6, 1999) (universal waste rule for lamps) (“[if] a [federal universal waste is] transported across a State in which it is subject to the full hazardous waste regulations … [t]ransport through the State must be conducted by a hazardous waste transporter and must be accompanied by a manifest”); 70 Fed. Reg. 45,508, 45,517 (August 5, 2005) (universal waste rule for mercury-containing equipment) (same). However, there appears to be a strong argument under the Hazardous Materials Transportation Act (HMTA) that state rules requiring a manifest are preempted if (as would be the case here) federal law does not require a manifest. See, e.g., Letter from Michael Shapiro, Director, Office of Solid Waste, EPA, to Richard J. Barlow, Chair, Northeast Waste Management Officials’ Association (June 11, 1996) (RCRA Online #14135) (“[although] preemption authorities are [generally] quite foreign to RCRA … they are introduced into the transporter area by the statutory directive in RCRA to maintain consistency with the DOT framework”); 49 Fed. Reg. 10,490, 10,492 (March 20, 1984) (federal law “prohibit[s] States from requiring separate State manifests or other information to accompany waste shipments”); id. at 10,494 (“States are not precluded from setting up another system of forms . . . as long as the system does not interfere with the actual shipment of waste [and] transporters [are] not . . . required to carry these forms”). Similar arguments may apply with respect to state requirements to use a hazardous waste transporter for a federally designated universal waste.

Next Steps

The final rule is expected to be published in the Federal Register in the next few weeks and will become effective at the federal level six months later, or approximately in early June 2020. The rule will not become effective in most states unless and until they act to adopt the rule, which (as discussed above) EPA says they will not be required to do (on the ground that the rule is less stringent than existing requirements). However, because several states have previously classified hazardous aerosol can wastes as universal wastes (e.g., California, Colorado, Utah, New Mexico, and Ohio) and another is poised to do the same (i.e., Minnesota), it can be reasonably expected that virtually all states will eventually follow EPA’s lead on this issue (possibly with some variations).

For more information about the final rule and its potential implications, please contact Aaron Goldberg or any other members of our Waste and Recycling practice group.

This article has been republished with permission of the author.  It was first published on the Beveridge & Diamond website.  


 

About the Author

Aaron applies his encyclopedic knowledge of hazardous waste regulatory law to help companies comply under federal and state laws—throughout all 50 states—and abroad.

He holds an advanced degree in chemistry, has extensive training in economics, and is a former U.S. Environmental Protection Agency consultant. His unique, multidisciplinary background—law, science, economics, and government—informs nearly every aspect of his work and makes him a useful bridge between attorneys, engineers, business managers, consultants, and regulators.

Aaron has focused on hazardous waste issues since the beginning of the federal regulatory program in 1980. With this historical experience, he offers clients comprehensive regulatory counsel on hazardous waste matters, including compliance strategy, advocacy, rulemaking challenges, end-of-life product management, permits, variances, and enforcement action response. His clients consist of companies and trade associations in the chemicals, electronics, recycling, petroleum, pharmaceuticals, retail, steel, and mining industries.

U.S.: New Hazardous Waste Pharmaceuticals Rule: Significant Changes Coming for Health Care Facilities, Particularly Long-Term Care Facilities

by Brooke F. Dickerson and Jennifer L. Hilliard,
Arnall Golden Gregory (AGG)

Health care facilities that provide a host of health care-related services or distribute, sell, or dispense pharmaceuticals will need to learn a whole new set of regulations thanks to a finalized new rule promulgated by the United States Environmental Protection Agency (EPA). The new rule revises management standards for hazardous waste pharmaceuticals (HWPs) such as urine drug tests for health care facilities, including nursing, skilled nursing, and inpatient hospice facilities, more than three years following the close of comments for the EPA’s initial proposed rule. The revised regulations will take effect six months following publication in the Federal Register.

The Resource Conservation Recovery Act (RCRA) governs the generation, management, storage, treatment, and disposal of hazardous wastes. Before the new rule was promulgated, certain health care facilities, such as hospitals and reverse distributors were subject to the same hazardous waste requirements under the RCRA as most industries. The management of HWPs at long-term care facilities, however, was excluded from the RCRA and treated the same as HWPs at residential households. EPA makes clear in this new rule that because nursing, skilled nursing, and inpatient hospice facilities are more akin to hospitals, their management of any hazardous waste, including HWPs, will also be subject to RCRA requirements.

The final rule revises some of the regulations and management standards for HWPs under the RCRA and sets them apart in a separate section of the RCRA regulations, to be codified at 40 C.F.R. Part 266, Subpart P (“Subpart P”), that are applicable specifically to health care facilities and reverse distributors. According to the EPA, this is necessary because hazardous waste generation and management practices at health care facilities differ significantly from those encountered in industry generally. As a result, regulating HWPs under the standard provisions of RCRA Subtitle C has been unnecessarily difficult. The EPA maintains that the new management standards are more streamlined and tailored specifically for healthcare HWPs and thus will promote proper management of HWPs by healthcare workers and pharmacy employees.

The final rule does not increase the universe of pharmaceuticals that are considered hazardous waste. However, it does accomplish four significant and practical changes in the management of pharmaceuticals: (1) HWPs that are to be sent off-site for reverse distribution will be regulated as hazardous wastes under the RCRA while still at the health care facility, (2) HWPs are banned from being disposed of down a drain or in a toilet, thereby reducing the amount of pharmaceutical ingredients that contaminate drinking water and endanger the environment, (3) it is easier to make a HWP container legally “empty,” and (4) nicotine replacement therapies are no longer considered potential hazardous wastes. Some of the components of the final rule will relieve the existing burdens on generators of HWPs, while other components may make the management of HWPs more onerous, at least initially.

Applicability to Long-Term Care Facilities

As noted above, the final rule applies to health care facilities. The definition of “health care facility” specifically includes long-term care facilities. A “long-term care facility,” in turn, is defined as:

[A] licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, Hospice Cincinnati facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities and the independent and assisted living portions of continuing care retirement communities. (emphasis added).

The exclusion of assisted living from the definition of long-term care facility in the rule avoids many of the practical issues with control over medications taken directly by patients and use of multiple pharmacies that flow from the functional differences between nursing homes and assisted living facilities. The distinction constitutes a welcome change from the 2015 proposed rule, which sought to include such facilities in the definition of long-term care facility. The EPA stated unequivocally that HWPs that are in (a) the custody of the long-term care facility on behalf of the resident, or (b) an in-house pharmacy maintained by such facility (if any), must be managed under Subpart P.

Definitions and Analysis

The analysis necessary to determine whether a given substance is considered a HWP involves three questions:

Question 1 – Is it a Pharmaceutical? Under the final rule, a pharmaceutical includes, but is not limited to, the following:

  • Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act;
  • Prescription drug, as defined by 21 C.F.R. § 203.3(y);
  • Over-the-counter drugs;
  • Homeopathic drugs;
  • Compounded drugs;
  • Investigational new drugs;
  • Pharmaceuticals remaining in non-empty containers;
  • Personal protective equipment contaminated with pharmaceuticals; and
  • Clean-up material from spills of pharmaceuticals.

The definition also includes any electronic nicotine delivery system and liquid nicotine packaged for retail sale. Excluded from the definition are sharps and dental amalgam.

Question 2 – Is it a Solid Waste? A solid waste is any discarded material that is not otherwise excluded under the regulations that implement RCRA. What constitutes a RCRA solid waste, however, is not limited to wastes that are physically solid. Many solid wastes are liquid, semi-solid, or gaseous material. A material is considered “discarded” once the facility has decided to discard it, and must be managed appropriately at that point in time. A material that is legitimately going to be used, reused or reclaimed is not discarded and is not a solid waste. Note, however, that under the final rule, EPA has pre-determined that a health care facility’s decision to reverse distribute a pharmaceutical constitutes a decision to discard the pharmaceutical.

Question 3 – Is it a HWP? Solid wastes that are pharmaceuticals are only considered hazardous waste under RCRA if they are either listed as hazardous wastes or exhibit one of the characteristics of hazardous waste. There are four lists–F , K , P and U –based on either manufacturing and industrial processes, or chemical designations. The F and K lists are based on manufacturing and industrial processes, none of which apply to pharmaceuticals for humans. The P and U lists are based on chemical products. The EPA notes that there are approximately 30 “Commercial Chemical Products” on the P and U lists that have uses in multiple pharmaceuticals. A Commercial Chemical Product is only a waste if (i) it has not been used or used as intended, and (ii) consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed or the chemical is the sole active ingredient in the formulation. If these criteria are not met, then the pharmaceutical is not a HWP, even if included in the P or U list.

As noted above, even if a pharmaceutical waste is not listed on any of the lists, it may also qualify as a hazardous waste if it exhibits one of the four characteristics of hazardous waste:

  • Ignitability (something flammable) – for example, solutions containing more than 24% alcohol,
  • Corrosivity (something that can rust or decompose) – for example, certain compounding chemicals,
  • Reactivity (something explosive), and
  • Toxicity (something poisonous).

The answer to all three of the foregoing questions must be yes for the material to qualify as a HWP, though the final rule does contain certain exceptions that may apply to exclude a pharmaceutical from being considered a HWP for purposes of RCRA Subpart P. A long-term care facility that determines that it does generate HWPs must then conduct further analysis to determine the nature of its obligations under Subpart P.

Scope of Obligations under Subpart P – Amount of Waste Generated

Once the determinations have been made that a long-term care facility is covered by the final rule and has HWPs, the analysis shifts from the type of facility and nature of the waste to the amount of the waste, to determine the scope of the facility’s obligations under Subpart P. Specifically, the next inquiry is the amount of HWPs that the facility generates. Under RCRA, a “Generator” is a person whose act or process produces hazardous waste or whose act first causes a hazardous waste to become subject to regulation. Therefore, a facility that makes the determination to “discard” a pharmaceutical becomes a Generator. A facility that generates less than or equal to any of the following per calendar month qualifies as a Very Small Quantity Generator (VSQG) :

  • 100 kg (220 pounds) of hazardous waste; or
  • 1 kg (2.2 pounds) of acute hazardous waste.

Under the final rule, long-term care facilities with 20 or fewer beds are presumed to be VSQGs, thereby shifting the burden of proof to the EPA Administrator to establish that a facility is not a VSQG. Facilities with more than 20 beds, however, bear the responsibility of demonstrating that they qualify as a VSQG.

If a facility generates total hazardous waste in amounts exceeding the VSQG thresholds, it must treat its HWPs in accordance with the management standards of Subpart P. While VSQGs may opt to handle their HWPs in accordance with the management standards of Subpart P, they are not required to do so except for the sewering ban and empty container provisions of Subpart P. If a VSQG does not opt to comply with the management standards of Subpart P, its HWPs are subject to the general hazardous waste provisions of 40 C.F.R. § 262.14, which may be less than the requirements of Subpart P. Further, a long-term care facility that is a VSQG may dispose of its HWPs (other than contaminated personal protective equipment or clean-up materials) in an on-site collection receptacle of an authorized collector that is registered with the Drug Enforcement Administration (DEA), provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable regulations for controlled substances.

Whether a long-term care facility that qualifies as a VSQG opts to treat its HWPs in accordance with the management standards of Subpart P likely will depend on (1) the willingness of the facility to undertake the monthly calculations, monitoring and recordkeeping required to demonstrate that their hazardous waste is within the limits established for VSQGs, or (2) whether the decision not to comply with Subpart P would render the facility subject to more onerous requirements on other hazardous waste that it generates. If a facility also generates non-pharmaceutical RCRA hazardous waste, such as lab wastes for example, those wastes are not regulated under Subpart P but under the existing RCRA regulations. The standard regulations become more stringent as the amount of applicable waste increases. Facilities could decrease the overall amount of waste and thus lessen the impact of the standard regulations by not including the HWPs that are managed instead under Subpart P.

Scope of Obligations under Subpart P – Prescription HWPs versus Non-Prescription HWPs and Non-Creditable Prescription HWPs versus Potentially Creditable Prescription HWPs

Once the determination has been made that a long-term care facility is subject to the management standards of Subpart P, the requirements vary based on whether or not the pharmaceutical required a prescription. For prescription drugs, a facility must determine if it is managing a potentially creditable HWP or a non-creditable HWP. A “potentially creditable hazardous waste pharmaceutical” is a prescription HWP that has a “reasonable expectation to receive manufacturer credit through reverse distribution and is (1) in original manufacturer packaging (except pharmaceuticals that were subject to a recall) even if opened; (2) undispensed; and (3) unexpired or less than one year past expiration date.”

A non-creditable HWP is a prescription pharmaceutical that does not meet the above three criteria and therefore is not likely to receive credit back through reverse distribution. Non-prescription HWPs that do not have a reasonable expectation to be legitimately used, reused or reclaimed are also considered non-creditable HWPs. On the other hand, non-prescription over the counter pharmaceuticals that go through reverse logistics because they have a reasonable expectation of being recycled are not “Solid Waste” under RCRA at all, and therefore are not subject to Subpart P either. The management standards for potentially creditable HWPs are not as stringent as those for non-creditable HWPs.

Because of the requirement that the pharmaceutical be undispensed, it is likely that only long-term care facilities that have an in-house long-term care pharmacy will be managing potentially creditable HWPs. Those long-term care facilities that contract for their pharmacy services with a long-term care pharmacy will be managing non-creditable HWPs because pharmaceuticals are considered to be dispensed when the order is filled by the external pharmacy.

Unlike the existing general RCRA standards for the management of hazardous wastes, standards for HWPs under the new Subpart P are the same regardless of the amounts generated or the places where they are accumulated.

Management Standards for Non-Creditable HWPs

Notification – A long-term care facility that is subject to the requirements of Subpart P must notify the EPA Regional Administrator within 60 days of the effective date of Subpart P (or within 60 days of becoming subject to Subpart P) that it is a healthcare facility operating under Subpart P, even if the facility already has an EPA Identification Number. Notification may be filed electronically. The facility must keep a copy of the notification on file for as long as the facility is subject to Subpart P. If the facility subsequently qualifies as a VSQG and elects to withdraw from Subpart P, it must so notify the EPA Regional Administrator and may not begin operating under the conditional exemption applicable to VSQGs generally under RCRA until notification has been made. Withdrawal notifications must be kept on file for a period of three (3) years.

Training – All facility personnel that manage HWPs must be trained and be “thoroughly familiar” with proper waste handling and emergency procedures relative to their responsibilities. EPA has not stated whether the agency will offer compliance assistance or training materials to facilities. As a result, because the final rule will become effective six months following publication in the Federal Register, facilities should begin exploring their options for training as early as possible.

Hazardous Waste Determination – The facility must determine whether a non-creditable pharmaceutical is a HWP. In lieu of making such a determination, the facility may choose to manage all waste pharmaceuticals as HWPs under Subpart P.

Containers – Because a facility will likely accumulate HWPs for some period of time before shipping them off-site, the final rule prescribes standards for containers that will be used to store HWPs. Generally, any container used to accumulate HWPs must be structurally sound, compatible with its contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Such container must be kept closed and secured so as to prevent unauthorized access to its contents.

Labeling Containers – All containers used to accumulate HWP must be labeled or clearly marked with the phrase “Hazardous Waste Pharmaceuticals.”

Maximum Accumulation Time – A facility may accumulate non-creditable HWPs on-site for a period not to exceed one year without a permit. The period begins on the date the pharmaceutical first becomes a waste, and the facility is responsible for demonstrating how long HWPs have been accumulating. The final rule allows the facility to make this demonstration by marking/labeling the container, maintaining an inventory system or by placing the HWPs in a specific area and identifying the earliest date that any of the HWPs in that area became a waste. To the extent that any HWPs are able to be commingled safely in a container, the date on which the very first HWP was deposited in the container would start the one year clock running.

Land Disposal Restrictions – A facility must comply with extensive requirements pertaining to land disposal restrictions at 40 C.F.R. Section 268.7(a), but these have been relaxed to the extent that the individual waste codes no longer need to be identified on the land disposal restriction notification.

Shipping – As noted above, a long-term care facility may accumulate non-creditable HWPs on-site only for a limited time before it must ship them off-site to a pre-designated authorized facility for treatment, storage or disposal. The final rule includes specific requirements for such shipments.

  • Pre-Transport
    • Packaging, Labeling and Marking – Generally, all waste must be packaged, labeled and marked in accordance with applicable Department of Transportation (DOT) regulations.
      • Containers of 119 gallons or less must be marked with specific words and information, including “HAZARDOUS WASTE.”
      • With limited exceptions specified in the final rule, lab packs that will be incinerated are not required to be marked with EPA Hazardous Waste Numbers.
    • Placarding – A long-term care facility must placard or offer the initial transporter the appropriate placards as specified under DOT regulations.
  • Manifests – A facility must use a uniform manifest and comply with applicable manifest requirements except that instead of listing the individual waste codes, the facility should write “PHARMS” on the form.
  • Facilities may ship HWPs across state lines, but will only be able to use the provisions in Subpart P if both states have adopted the same regulations (see below).

Managing Rejected Shipments – A long-term care facility will need to ship any rejected shipments of non-creditable HWPs to a new designated and authorized facility within 90 days of their return.

Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by the EPA. Other than the initial notification, the only report required under the new rule is when the facility does not receive back a copy of a fully received manifest from the receiving facility in connection with a shipment.

Record keeping – A health care facility must keep a copy of each manifest, exception report, and hazardous waste determination test result and analysis for three years. All records must be readily available during an inspection.

Response to Spills – Spills of HWPs must be immediately contained and the cleanup materials managed themselves as HWPs.

Accepting Non-Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept non-creditable HWPs from a VSQG, such as when a health care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.

Management Standards for Potentially Creditable HWPs

As noted above, because the definition of a potentially creditable HWP requires that a pharmaceutical be undispensed, and the use of a third party long-term care pharmacy results in medication being dispensed to a resident by the pharmacy rather than the facility, most long-term care facilities will not be managing potentially creditable HWPs. However, for those facilities that maintain their own in-house long-term care pharmacy, the requirements of the final rule with respect to potentially creditable HWPs are relevant as the facility is likely to have undispensed prescription medications on hand that can qualify as potentially creditable HWPs that can be sent to a reverse distributor.

  • Accepting Potentially Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept potentially creditable HWPs from a VSQG, such as when a care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.
  • Only Potentially Creditable HWPs – A facility is prohibited from sending hazardous wastes other than potentially creditable HWPs to a reverse distributor.
  • Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by EPA.
  • Recordkeeping – A facility that initiates a shipment of potentially creditable HWPs to a reverse distributor must retain for a period of three years paper or electronic records of (i) the confirmation of delivery, and (ii) shipping papers prepared in accordance with DOT regulations. All records must be readily available during an inspection.
  • Response to Spills – Spills of potentially creditable HWPs must be immediately contained and the cleanup materials managed as non-creditable HWPs.
  • Shipping – Unlike with respect to a non-creditable HWP, a manifest is not required for shipping potentially creditable HWPs to a reverse distributor. Nevertheless, the facility must comply with all applicable DOT regulations in 49 C.F.R. Parts 171 through 180 for any HWP that meets the definition of “hazardous material” in 49 C.F.R. Section 171.8. Also, the receiving reverse distributor must provide confirmation to the facility that it has received the shipment. If the facility has not received such confirmation within 35 calendar days from the date the potentially creditable HWPs were sent, the facility must contact the carrier and the reverse distributor promptly to report that the confirmation was not received and to determine the status of the potentially creditable HWPs.

Conditional Exemption for HWPs that are Controlled Substances:

The final rule includes a conditional exemption from RCRA requirements for HWPs that are listed on a schedule of controlled substances by the DEA. The conditional exemption will apply if the HWPs are collected, stored, transported, and disposed of in compliance with all applicable DEA regulations for controlled substances, and will be destroyed by a method that DEA has publicly deemed in writing to meet their non-retrievable standard of destruction or combusted at one of five types of combustion facilities.

Generally Applicable Provisions of Subpart P to all HWPs:

The following provisions apply to all health care facilities, regardless of whether the facilities are managing creditable or non-creditable HWPs or are required to comply with the other provisions of Subpart P.

  • Sewering Ban – All health care facilities covered by the rule are prohibited from discharging HWPs to a sewer system that passes through to a publicly-owned treatment works.
  • Empty Containers – Under the new regulations, certain stock, dispensing and unit-dose containers are considered “empty” and therefore not regulated as hazardous waste under RCRA, even if minor pharmaceutical residue remains, if they have been emptied using the practices commonly employed to remove materials from that type of container. This also applies to syringes provided that the contents have been removed by fully depressing the plunger into the patient, another delivery device such as an intravenous bag, or a hazardous waste collection container. Intravenous bags avoid RCRA regulation provided the pharmaceuticals inside have been fully administered to a patient. All other types of containers—whether partially or completely empty—are to be managed as non-creditable HWPs unless they meet the general RCRA empty test for non-acute hazardous wastes.

Over the Counter Nicotine Replacement Therapies:

Nicotine and salts are currently included in the hazardous waste listed code P075 . The new rule exempts FDA approved over the counter nicotine replacement therapies, specifically patches, gums, and lozenges, from waste code P075. The rule does not exempt e-cigarettes, nicotine-containing e-liquids or prescription nicotine replacement therapies because they are not regulated in the same way as the exempted methods. Nevertheless, any nicotine replacement therapy that has been used in the manner initially intended is not a “solid waste” under RCRA and therefore is not a “hazardous waste” either.

Effective Date; Authorized State RCRA Programs:

The final rule will become effective six months following publication in the Federal Register; however, many states operate their own hazardous waste program. Once authorized by EPA, state hazardous waste programs operate in lieu of the RCRA regulations, though authorized states are required to adopt new regulations that are more stringent than existing rules. Most provisions of the pharmaceutical waste final rule are more stringent than the current RCRA generator regulations. Accordingly, authorized state programs will be required to adopt those provisions such that the new rule will not take effect in any of those states until it has been adopted and the state regulations updated. In contrast, the ban against HWP disposal in a drain or a toilet will be effective in every state as soon as it is effective under Federal law because the sewering prohibition component of the new rule, also more stringent than existing requirements, was adopted under separate legal authority. States are not required to adopt the part of the rule exempting over-the-counter nicotine replacement therapies from the hazardous waste requirements because it is less stringent. Also, facilities should be aware that states may include more stringent requirements than those included in the final rule. As a result, facilities will need to monitor adoption and implementation efforts in those states very closely.

Conclusion:

There can be no doubt that EPA’s final rule will require health care facilities, particularly long-term care facilities other than assisted living facilities, to navigate the new regulatory framework provided in Subpart P, while still potentially being subject to many other RCRA-related provisions and to regulations from other Federal agencies including the DOT. Additionally, facilities in states that have their own authorized hazardous waste program will need to monitor their state agency to determine exactly which rules apply and when. With an effective date only six months following publication of the final rule in the Federal Register, no guarantees of education or compliance assistance from EPA other than three webinars scheduled for February and March, 2019, and steep fines for violations, facilities will be hard-pressed to come up to speed in time. Health care facilities are well advised to begin their efforts now to understand the requirements, draft and implement effective policies and procedures, develop a staff training program, and enter into such contractual relationships as may be necessary to ensure compliance.

This article has been republished with the permission of the authors. It was first published on the AGG website. A pdf version, with footnotes can be found at AGG Legal Insight.


About the Authors

Brooke F. Dickerson focuses her practice on transaction, regulatory, compliance and permitting matters. With regards to environmental work, she has significant experience with Superfund (CERCLA), hazardous waste (RCRA and HWMA), the Georgia Hazardous Site Response Act (HSRA), solid waste, Brownfields, wetlands, and site evaluation, assessment and remediation issues. She also advises clients on stormwater compliance, green leasing issues and green/sustainable building practices. With regards to construction work, Ms. Dickerson advises owners and developers on the drafting and negotiation of architect, construction and construction management agreements. She has represented clients in connection with the construction of office, multi-family, mixed use and tenant improvement projects. She also advises clients on OSHA matters and has represented several companies in obtaining reduced or dismissed penalties in settlement negotiations.

Jennifer Hilliard is Of Counsel in the Healthcare Practice. Ms. Hilliard focuses her practice on long-term care and aging services issues generally. She has extensive experience with nursing home regulatory matters, compliance and operations. Additionally, she has significant experience with Federal public policy and government affairs in such related areas as Medicare and Medicaid regulation, home health and hospice regulation, DEA controlled substances regulation, OSHA and other labor and employment issues affecting aging services providers, and federal non-profit tax issues. Prior to joining AGG, Ms. Hilliard served for over 18 years in a variety of legal and advocacy-related capacities at LeadingAge, a Washington, DC based trade association for non-profit long-term care and aging services providers.