Now it’s official – No Drugs Down the Drain and We Mean All Drugs
Effective August 21, 2019 the EPA has now banned healthcare facilities from flushing (“sewering”) any and all drugs including the hazardous waste drugs previously on on a flush list for healthcare providers. Finally!
- EPA’s website with details on the new no-flush rule
- EPA’s full Q&A section about the new no-flush rule
- News article from American Pharmacists Association
Q&A by the EPA – The Sewer Ban
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?
ealthcare 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.