Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Final Rule
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- Why is EPA finalizing management standards for hazardous waste pharmaceuticals?
EPA has two primary reasons for this final rule. First, to address concerns raised by stakeholders regarding the difficulty in implementing the industry-oriented Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for the management of hazardous waste pharmaceuticals generated at healthcare facilities and managed at reverse distributors. This rule revises and tailors the hazardous waste regulations to improve the management of hazardous waste pharmaceuticals by the healthcare sector and thereby enhance protection of human health and the environment.
Second, a number of studies have documented the presence of various pharmaceutical active ingredients and metabolic by-products in surface waters and groundwater in the United States. The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations. These findings highlight the increasing importance of pharmaceutical use and management, and have led EPA to finalize a prohibition on disposing hazardous waste pharmaceuticals down the drain by those entities subject to this rule.
- What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?
EPA’s final rule will reduce the risk caused by hazardous waste pharmaceuticals that enter the environment through flushing down the sink or toilet. Specifically, this final rule is projected to prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually by banning the drain disposal (flushing, sewering) of hazardous waste pharmaceuticals.
With this final rule, EPA strives to improve compliance at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors that generate and manage hazardous waste pharmaceuticals in order to improve environmental protection. Specifically, EPA enhances public health protection by decreasing the risk of diversion of unused hazardous waste prescription pharmaceuticals onto the black market by requiring basic tracking of these pharmaceuticals from healthcare facilities to reverse distributors. Additionally, this final rule creates an environmentally preferable, convenient and practical management system that EPA encourages the healthcare sector to use for all waste pharmaceuticals.
- Who is affected by this final rule?
Healthcare facilities and reverse distributors that generate and manage hazardous waste pharmaceuticals will follow these new, tailored standards for managing their hazardous waste pharmaceuticals instead of the industry-oriented hazardous waste generator regulations.
This rule does not apply to pharmaceutical manufacturers (unless they act as reverse distributors), production facilities or other generators of hazardous waste pharmaceuticals.
In addition, anyone who generates or manages discarded Food and DrugFDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) is also affected by the amendment to the P075 listing for nicotine that is also part of this final rule. See the Question & Answer below for more information on the amendment to the P075 listing for nicotine that is part of this final rule.
- Which pharmaceuticals are considered hazardous waste?
As thousands of over-the-counter and prescription drugs are currently approved for sale in the United States, it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, a solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations (40 CFR) Part 261.
There are approximately 30 commercial chemical products listed on the P and U hazardous waste lists that have pharmaceutical uses. As the P and U lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are all designated as a U058 hazardous waste for cyclophosamide.
In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide.
Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (hazardous waste code D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).
- Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?
Hazardous waste generation and management practices at healthcare facilities differ from practices of industrial hazardous waste generators in several ways that make the application of RCRA subtitle C hazardous waste regulations difficult. Pharmaceutical waste is typically generated at a large number of points in relatively small quantities across a facility, such as at nursing stations, pharmacies and patient, emergency and operating rooms. Furthermore, generators of hazardous waste pharmaceuticals tend to generate hundreds of different types of pharmaceutical waste while, in contrast, many industrial generators tend to generate only a few predictable waste streams in large quantities at relatively few generation points. Some of the difficulties that generators of hazardous pharmaceutical wastes have expressed concerning the current hazardous waste generator regulations relate to making the waste determination, generator status upgrade due to generation of acutely hazardous waste, hazardous waste listings, and accumulation time limits.
- Why do hazardous waste pharmaceuticals need new management standards?
Healthcare workers and retail pharmacy employees are often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to dispose of hazardous pharmaceuticals as municipal waste or medical waste. This final rule streamlines the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Additionally, the rule finalizes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system.
Under this final rule, EPA expects that the management of hazardous waste pharmaceuticals to improve and the regulatory burden for many hazardous waste pharmaceutical generators will decrease. This final rule provides a solution to many of the issues facing healthcare facilities. By finalizing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA encourages healthcare facilities to manage all of their pharmaceutical waste - non-hazardous and hazardous - under the final rule.
- How will discarded over-the-counter nicotine replacement therapies be regulated?
This final rule exempts FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) from regulation as a RCRA hazardous waste (specifically, these wastes are exempt from the RCRA Hazardous Waste Code P075 for nicotine). Therefore, under the federal hazardous waste regulations, generators of these wastes (e.g., retail stores) may discard them as non-hazardous waste. This provision of the final rule must be in effect in your state in order for facilities to use this exemption. Please check with your state.
- How do these final regulations differ from the current hazardous waste generator regulations?
Under previous requirements, any facility that generates hazardous waste pharmaceuticals was subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the final management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under 40 CFR part 266, subpart P instead of the standard RCRA generator regulations found in 40 CFR part 262. Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:
- A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
- A healthcare facility will not need to specify hazardous waste codes on manifests;
- A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
- A healthcare facility will have basic training requirements.
Additionally, the final standards are tailored to how reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at reverse distributors.
- When will this final rule go into effect?
This final rule will be effective at the federal level six months after the rule is published in the Federal Register.
Authorized states are required to adopt this final rule and to modify their RCRA programs in order to retain their authorized status because this rule is more stringent than current RCRA generator regulations. This rule will not become effective in states authorized for the RCRA program until states have adopted the rule, with one exception.
The exception is the ban on flushing hazardous waste pharmaceuticals. This particular requirement is being finalized under the Hazardous and Solid Waste Amendments (HSWA). Requirements promulgated under HSWA authority become effective in all states on the effective date of the federal regulation, which is six months after publication of the final rule in the Federal Register.
The exemption from the P075 listing for FDA-approved over-the-counter nicotine replacement therapies is less stringent than current regulation. Authorized states are not required to adopt less stringent regulations. The exemption for over-the-counter nicotine replacement therapies will not become effective in states authorized for the RCRA program until states have adopted the exemption.
- What is a “healthcare facility” under this final rule?
Healthcare facility means any person that is lawfully authorized to—
- 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
- Distribute, sell, or dispense 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.
The definition of healthcare facility does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers. See 40 CFR section 266.500.
We note that a healthcare facility that is co-located within a facility that is not a healthcare facility (e.g. a clinic at a military base, school, or manufacturer), must operate as a healthcare facility under 40 CFR Part 266 Subpart P. However, if the entire facility is a very small quantity generator (VSQG), the co-located clinic does not have to operate as a healthcare facility under 40 CFR Part 266 Subpart P, except that the clinic must comply with the sewer prohibition and the new empty container standards in 40 CFR section 266.507.
- Is a long-term care facility such as a “nursing home” considered a “healthcare facility” under this final rule?
Yes. A “long-term care facility” is a type of healthcare facility. This rule defines a long-term care facility to mean 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 facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. See 40 CFR section 266.500.
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. See 40 CFR section 266.500.
- What is the definition of reverse distributor under the final rule?
Reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need. Reverse distributors generally have contracts with healthcare facilities to help the healthcare facility manage its unused and sometimes expired waste pharmaceuticals.
Healthcare facilities send their unused pharmaceuticals to a reverse distributor they have a contract with and the reverse distributor reviews the unused pharmaceuticals received and works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then reverse distributor sends the waste pharmaceuticals for disposal.
In the final rule, a reverse distributor is defined 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.
- What is a pharmaceutical for purposes of the Hazardous Waste Pharmaceuticals Final Rule?
The definition of a pharmaceutical includes drugs for human or animal use, including prescription and over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, compounded drugs, investigational new drugs, as well as nicotine e-liquids packaged for retail sale and electronic nicotine delivery systems (e.g., e-cigarette or vaping pen).
- The Resource Conservation and Recovery Act (RCRA) Hazardous Waste Pharmaceuticals Final Rule (February 22, 2019; volume 84 of the Federal Register starting on page 5816) prohibits the sewering (i.e., flushing or pouring down the drain) of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors (see 40 CFR section 266.505). To which pharmaceuticals does the sewer prohibition apply?
Section 266.505 of title 40 of the CFR prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW). The sewer prohibition applies to RCRA hazardous waste pharmaceuticals that are also controlled substances under the Drug Enforcement Administration (DEA) regulations and collected household pharmaceuticals (see 40 CFR section 266.506). We note that although the sewer prohibition applies to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting (with few exceptions, such as sterile water, 0.9 percent sodium chloride (saline) and Ringer’s lactate solution).
- Does a healthcare facility that is a very small quantity generator (VSQG) have to comply with the sewer prohibition?
Yes. All healthcare facilities, including VSQGs, must comply with the sewer prohibition for hazardous waste pharmaceuticals. See 40 CFR section 266.505.
- When is the sewer prohibition effective?
The sewer prohibition is effective August 21, 2019, in all states, territories and Indian Country. This is because this portion of the Rule was promulgated pursuant to the 1984 Hazardous and Solid Waste Amendments (HSWA). The sewer prohibition is the only provision of the Hazardous Waste Pharmaceuticals Final Rule that was promulgated under HSWA authority. As a HSWA provision, the sewer prohibition goes into effect on the effective date of the rule (August 21, 2019) regardless of whether a government has received authorization to implement RCRA or has adopted Subpart P.
- When the sewer prohibition becomes effective on August 21, 2019, are healthcare facilities and reverse distributors required to submit a notification (i.e., Site Identification Form 8700-12) to EPA that they are operating under Part 266 Subpart P?
Healthcare facilities and reverse distributors that are in an authorized state or territory that has not yet adopted Subpart P do not have to submit a notification to EPA until after the state or territory adopts Subpart P. Because the sewer prohibition is a HSWA provision, it becomes effective on August 21, 2019 in all states, territories and Indian Country regardless of whether the government is authorized to implement RCRA or has adopted Subpart P. However, the rest of Subpart P, including requirements for healthcare facilities and reverse distributors to submit a notification, is not effective in an authorized state or territory until the state or territory adopts this final rule.
Healthcare facilities and reverse distributors that are in Indian Country, territories other than Guam, or unauthorized states (Alaska and Iowa), are required to notify EPA by 20 October 2019 (using form 8700-12) or 01 March 2020 (for those who choose to notify via their Biennial Report).
- Who will be responsible for enforcing the sewer prohibition?
The sewer prohibition of Subpart P will be enforced through RCRA inspections of healthcare facilities and reverse distributors by state or federal officials. The Clean Water Act’s NPDES pretreatment program could also potentially apply and result in enforcement of requirements of the sewer prohibition if such requirements are adopted as part of a publicly owned treatment works’ approved pretreatment program. Further, elements of the sewer prohibition may be reflected currently in the specific prohibitions on discharge by indirect users of POTWs in EPA’s Pretreatment Regulations at 40 CFR Part 403.
- Can hazardous waste pharmaceuticals that contain a radioactive component be discharged to the sewer?
No. Hazardous waste pharmaceuticals that also contain a radioactive component subject to the Atomic Energy Act of 1954 (i.e., “mixed waste”) are regulated by multiple agencies. The hazardous waste component is regulated under EPA or the authorized state RCRA programs, while either the Nuclear Regulatory Commission or the Department of Energy regulates the radioactive component of the waste under the Atomic Energy Act. Therefore, a “mixed waste” pharmaceutical that is both radioactive and RCRA hazardous waste is prohibited from being discharged to the sewer.
- Can hazardous waste pharmaceuticals be discharged to septic tanks?
No, 40 CFR section 261.4(a)(1)(ii) allows the discharge of what would otherwise be a hazardous waste to publicly owned treatment works (POTWs), without being considered solid or hazardous waste. The prohibition on discharges of hazardous waste pharmaceuticals that was promulgated as part of the Hazardous Waste Pharmaceuticals final rule reduces the scope of the exclusion in the existing regulations. Discharges of hazardous waste to other types of sewage systems, such as septic tanks, privately owned treatment works and federally owned treatment works are not allowed by the exclusion in 40 CFR section 261.4(a)(1)(ii). Therefore, the discharge of hazardous wastes to septic tanks, privately owned treatment works and federally owned treatment works is already prohibited, even though it is not explicitly stated in the sewer prohibition of Subpart P.
- Can hazardous waste pharmaceuticals be discharged to the sewer from a healthcare facility or reverse distributor that has a pretreatment permit?
No, 40 CFR section 266.505 prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW), regardless of whether the POTW or state has issued a pretreatment permit to the healthcare facility or reverse distributor.
- The Clean Water Act General Pretreatment Regulations for Existing and New Sources of Pollution, 40 CFR Part 403, already contain several sewer bans of hazardous wastes (e.g., liquid ignitable D001 hazardous wastes and some D002 and D003 hazardous wastes) under 40 CFR section 403.5(b). Should the HSWA sewer prohibition for hazardous waste pharmaceuticals be incorporated as another “Specific Prohibition” into local Sewer Use Ordinances (SUOs)?
No. The HSWA sewer prohibition for hazardous waste pharmaceuticals is not required to be added to local SUOs. However, a locality may elect to add a new sewer prohibition to its SUO if it has legal authority to do so.
EPA notes that the existing Clean Water Act (CWA) specific discharge prohibitions at 40 CFR section 403.5(b) are broader than just pharmaceuticals and apply beyond healthcare facilities and reverse distributors. Specifically, these CWA prohibitions (e.g., discharge of pollutants creating a fire or explosive hazard, causing corrosive damage) would typically ban any industrial user discharges of the following RCRA characteristic hazardous wastes (RCRA and CWA regulatory citations, respectively, are included):
- hazardous waste discharges of D001 ignitable liquids (sections 261.21(a)(1) and 403.5(b)(1))
- acidic D002 hazardous wastes (sections 261.22(a)(1) and 403.5(b)(2))
- D003 reactive hazardous wastes that
(1) react violently with water (sections 261.23(a)(2) and 403.5(b)(1)) or
(2) form potentially explosive mixtures with water (sections 261.23(a)(3) and 403.5(b)(1)) or
(3) when mixed with water, result in the presence of toxic gases, vapors or fumes within the POTW in a quantity that may cause acute worker health and safety problems (sections 261.23(a)(4) and 403.5(b)(7)) or
(4) it is a cyanide or sulfide bearing waste which, when exposed to pH conditions between two (2) and 12.5, can generate toxic gases, vapors or fumes in a quantity sufficient to present a danger to human health or the environment (sections 261.23(a)(5) and 403.5(b)(7)).
- Does the sewer prohibition apply to pharmaceutical manufacturers?
The sewer prohibition does not apply to pharmaceutical manufacturers unless those same facilities are also reverse distributors. A reverse distributor is defined in 40 CFR section 266.500, “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.”
While the sewer prohibition legally applies only to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting (with few exceptions, as noted in an earlier question). EPA promulgated Effluent Guidelines and Standards for Pharmaceutical Manufacturing at 40 CFR Part 439, which address CWA discharges of pollutants associated with this industry.
- What are the oversight and enforcement responsibilities of a Clean Water Act control authority regarding healthcare facilities?
EPA has not established technology-based standards for discharges from healthcare facilities to POTWs, thus healthcare facilities are not categorical industrial users (CIUs). Healthcare facilities continue to be industrial users (IUs), defined broadly at 40 CFR section 403.3(j) as a “Source of Indirect Discharge,” and may be significant industrial users (SIU), defined at 40 CFR section 403.3(v).
40 CFR section 403.8(f) directs POTWs to establish procedures and standards to identify all IUs to ensure compliance with the general and specific prohibitions to protect against pass through and interference. Control authorities, however, have discretion and flexibility on what those requirements should be for IUs (non-CIUs and non-SIUs). As a POTW’s procedures are uniquely tailored to the capacity and capability of each POTW, as well as the NPDES permit requirements for the individual receiving water body, control authorities should refer to their programs’ procedures and NPDES permit conditions to understand their requirements as they relate to all industrial users. Control authorities have the option to modify their programs to adapt their otherwise applicable procedures. This option may be considered a substantial modification, which has special requirements described in 40 CFR section 403.18. Control authorities may work with their approval authority for assistance with questions on handling specific oversight, enforcement or program modification questions.