“Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine”
US EPA’s Final Rule creating new management standards for hazardous waste pharmaceuticals titled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” appeared in the Federal Register, February 22, 2019.
Initially proposed in 2015, the new standard allows pharmaceutical distributors and healthcare facilities that manage these wastes to exclude hazardous waste pharmaceuticals (HWP) from regulation under the more stringent Resource Conservation and Recovery Act (RCRA) hazardous waste management standards. Streamlined standards for management of these wastes are now found under Subpart P of 40 CFR Part 266. In addition to the new HWP management standards, EPA is excluding some FDA-approved nicotine replacement therapies from regulations as hazardous waste with this rulemaking. The rule also bans the flushing of hazardous waste pharmaceuticals down the drain.
“Potentially Creditable” and “Potentially Non-Creditable” Hazardous Waste Pharmaceuticals
The rule creates separate management standards for “potentially creditable” hazardous waste pharmaceuticals (i.e., wastes eligible for reverse distribution) and “potentially non-creditable” hazardous waste pharmaceuticals (i.e., wastes not eligible for reverse distribution).
Highlights of the rule applicability include:
- Goes into effect June 2019 for states under EPA RCRA authority;
- States that are authorized to implement the RCRA program must adopt the more stringent portions of the rule, which become effective in that state upon adoption;
- The rule ban on flushing of hazardous waste pharmaceuticals down the drain becomes effective in all states regardless of RCRA authority 6 months (August 22, 2019) after publication in the federal register.
- The on-site management of potentially creditable hazardous waste pharmaceuticals simplifies current regulatory requirements. For example, shipments may be made by common carrier, hazardous waste manifests are no longer required, and biennial reporting requirements for LQGs is eliminated.
- Updated applicability for managing FDA-approved over-the-counter nicotine replacement therapies, such as patches and gum, stating these will no longer meet the definition of a P075 hazardous waste for nicotine.
EPA lists the following benefits of the rule under Subpart P for healthcare facilities:
- A healthcare facility will not become a large quantity generator (LQG), with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month.
- There are NO generator categories
- All healthcare facilities are regulated the same for their hazardous waste pharmaceuticals.
- Do not have to keep track of how much hazardous waste pharmaceuticals generated per month and do not have to segregate the acute and non-acute hazardous waste pharmaceuticals.
- Will not have to comply with the satellite accumulation area regulations;
- Will not need to specify hazardous waste codes on manifests;
- Will be able to accumulate hazardous waste pharmaceuticals on site for one year;
OF THE RULE
Over-the-counter pharmaceuticals, dietary supplements and homeopathic drugs are not a solid waste, as defined in § 261.2, and therefore are excluded the final rule’s definition of hazardous waste.
Prescription hazardous waste pharmaceuticals are always subject to Subpart P, whether they are sent to a reverse distributor as “potentially creditable hazardous waste pharmaceuticals” or sent to a disposal facility as “noncreditable hazardous waste pharmaceuticals.” Nonprescription pharmaceuticals are subject to Subpart P when they are discarded by a health care facility.
Sewer Prohibition (40 CFR 266.505) The new rule prohibits the disposal of hazardous waste pharmaceuticals and U.S. Drug Enforcement Administration (DEA) controlled substances in sinks that enter a municipal sewer system. Additionally, hazardous waste pharmaceuticals that are also controlled substances must be combusted at a permitted hazardous waste incinerator or municipal solid waste incinerator. This prohibition includes Very Small quantity Generators (VSQG). The effective date of the sewer prohibition will be August 22, 2019 for all states.
Management and shipping requirements. “Noncreditable hazardous waste pharmaceuticals” are subject to Section 266.502 management requirements and Section 266.508 shipping requirements, similar to current small quantity generator (SQG) requirements. Potentially creditable hazardous waste pharmaceuticals are subject to relaxed management standards in Section 266.504 and shipping standards in Section 266.509.
Nicotine Replacement Therapies. Nicotine replacement therapy (NRT) products, which include gums, lozenges and patches have historically been considered acute hazardous waste. The new rule for hazardous waste code P075 in 40 CFR 261.33(e) exempts FDA-approved over-the-counter NRTs. Once the final rule is effective, these NRTs will be considered nonhazardous wastes and not subject to hazardous waste regulations. Other unused formulations of nicotine will still be considered P075 when discarded, including E-liquids/e-juices in e-cigarettes, cartridges, or vials.
Agency Notification: All healthcare facilities must submit a one-time notification that they are operating under Subpart P (using Site ID Form: 8700-12).
- Facilities that are not required to submit a biennial report for their other hazardous waste must notify within 60 days of the rule going into effect. Non-authorized states: notifications will be due in October 2019.
- Facilities that are required to submit a biennial report may notify on their normal biennial reporting cycle.
Employee Training: All personnel managing “non-creditable hazardous waste” pharmaceuticals must be thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.
Hazardous Waste Determinations: Healthcare facilities must determine whether a waste pharmaceutical is a hazardous waste pharmaceutical. This applies to both potentially creditable and non-creditable waste pharmaceuticals
Exception: If a healthcare facility manages all of its waste pharmaceuticals as hazardous, individual hazardous waste determinations are not necessary.
Commingling: Healthcare facilities may accumulate both their hazardous and non-hazardous waste pharmaceuticals in the same container.
Labeling: For non-creditable hazardous waste pharmaceuticals accumulation containers must be labeled with the words “Hazardous Waste Pharmaceuticals.” There are no hazardous waste codes or other labeling requirements.
For non-creditable hazardous waste pharmaceuticals accumulation containers:
- Containers must be structurally sound, will not react with contents (i.e., compatible).
- Remain closed and secured in a manner that prevents unauthorized access to its contents.
- Accumulation time: 1 year
For potentially creditable hazardous waste pharmaceuticals:
- No labeling, containers standards or accumulation time
RCRA hazardous wastes that are also DEA controlled substances: Are exempt from RCRA, provided they are not sewered, managed in compliance with DEA regulations, and destroyed by a method that the DEA has deemed to meet their non-retrievable standard, or combusted at a permitted facility (i.e., municipal waste combustor, hospital, medical and infectious waste incinerator, commercial and industrial waste incinerator or hazardous waste combustor).
Empty Containers and Residues: Empty container standards apply to containers with hazardous waste pharmaceuticals, both acute and non-acute.
- Residues remaining in “RCRA empty” containers are not regulated as hazardous waste.
- Triple rinsing of containers with acute hazardous waste pharmaceuticals is not allowed (sewer ban).
- Residues in syringes: Residues in syringes will not be regulated as hazardous waste as long as the syringe is managed in accordance with applicable medical waste regulations.
- Residues in delivery devices: Containers such as IV bags and tubing, inhalers, and nebulizers will continue to be regulated as hazardous waste.
Shipping Manifests: For potentially “creditable hazardous waste pharmaceuticals,” manifest and hazardous waste transporters are NOT required. Common carriers (e.g., UPS, USPS, FedEx) are acceptable.
For non-creditable hazardous waste pharmaceuticals, manifest and hazardous waste transporter are required. When shipped by a healthcare facility, use “PHARMS” on manifest instead of hazardous waste codes.
The Federal Register can be found at the EPA Website: https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075
For more information, contact your EPS consultant.