Date: Sep 28, 2015
On September 25, 2015, the U.S. Environmental Protection Agency proposed new regulations for hazardous waste pharmaceuticals.1 The proposed regulations are intended to provide greater flexibility under the Resource Conservation and Recovery Act (RCRA)2 to healthcare facilities and pharmaceutical reverse distributors managing hazardous waste pharmaceuticals.3 In practice, the rule as proposed would likely encourage the use and expansion of reverse distribution networks for pharmaceuticals.
Under existing RCRA regulations, some pharmaceuticals are regulated as hazardous waste when disposed. These include pharmaceuticals that exhibit one or more of the four hazardous waste characteristics (ignitability, corrosivity, reactivity, or toxicity)4 and commercial chemical products, such as warfarin, that are specifically listed in 40 C.F.R. § 261.33 (P- and U-listed wastes). Consequently, healthcare facilities may be regulated as Small Quantity Generators (SQGs) or Large Quantity Generators (LQGs) of hazardous waste, based on the volume of discarded hazardous waste pharmaceuticals and other hazardous waste they generate per month.5
The proposed rule would require healthcare facilities that are currently regulated as SQGs or LQGs to manage hazardous waste pharmaceuticals under a sector-specific framework rather than the standard hazardous waste requirements. A new category of hazardous waste entity, pharmaceutical reverse distributors, would also be required to manage their hazardous waste pharmaceuticals according to the new regulations. Pharmaceutical reverse distributors (PRDs) are defined in the proposed rule as persons who receive and accumulate potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer's credit; this may include forward distributors and pharmaceutical manufacturers.6 Importantly, the rule (if finalized) would change an existing EPA position to interpret the decision to send a pharmaceutical to a PRD to be a decision to discard the pharmaceutical and trigger classification as a solid waste, based on EPA's determination that nearly all pharmaceuticals that are sent to PRDs are discarded by the distributor or the manufacturer.7 A new requirement for all healthcare facilities and PRDs is a prohibition on disposal of hazardous waste pharmaceuticals by "sewering" (e.g., disposal in a commode, sink, or floor drain).8
EPA's proposal distinguishes between creditable and non-creditable hazardous waste pharmaceuticals. Creditable hazardous waste pharmaceuticals are unused pharmaceuticals that have the potential to be returned to the manufacturer for financial credit.9 The proposed rule does not create on-site management standards for creditable hazardous waste pharmaceuticals at healthcare facilities.10 By comparison, non-creditable hazardous waste pharmaceuticals must be managed at healthcare facilities in accordance with requirements that are very similar to those in the previously proposed Universal Waste rule for pharmaceutical waste.11 Offsite shipment to PRDs for both creditable and non-creditable hazardous waste pharmaceuticals would need to comply with Department of Transportation (DOT) hazardous material transport requirements.12 For creditable hazardous waste pharmaceuticals shipped to a PRD, however, advance notice to the PRD and delivery confirmation can be used in place of a hazardous waste manifest and a hazardous waste transporter.13 Under proposed section 266.510, PRDs will need to meet requirements that are similar to the existing requirements for LQGs.
The proposed rule also provides flexibility for managing empty pharmaceutical containers. Specifically, the proposal would remove them from the empty container requirements at 40 C.F.R. § 261.7, if the contents of the container have been fully dispensed by removing all pharmaceuticals that can be removed using the practices commonly employed to remove materials from that type of container; the residues (and therefore the container) then can be disposed of as non-hazardous waste.14 As part of this exemption, EPA is proposing that "RCRA empty" pharmaceutical containers that are original manufacturer's pharmaceutical packages (dispensing bottles, vials or ampules typically used in pharmacies) must be destroyed prior to placing them in the trash, in order to eliminate concerns that they could be diverted from the solid waste stream and used for packaging counterfeit pharmaceuticals.15
EPA will accept comments on the proposal until November 24, 2015. For more information on EPA's proposal, or any other RCRA issues, please contact JC Walker at (202) 434-4181 or email@example.com, or Greg Clark at (202) 434-4302 or firstname.lastname@example.org.
1Management Standards for Hazardous Waste Pharmaceuticals, 80 Fed. Reg. 58,014 (Sept. 25, 2015), available at: https://www.federalregister.gov/articles/2015/09/25/2015-23167/management-standards-for-hazardous-waste-pharmaceuticals.
242 U.S.C. § 6901 et seq.
3A hazardous waste pharmaceutical is defined as "a pharmaceutical that is a solid waste, as defined in § 261.2, and is listed in part 261, subpart D, or exhibits one or more characteristics identified in part 261, subpart C." 80 Fed. Reg. at 58,083 (to be codified at 40 C.F.R. § 266.500).
4See 40 C.F.R. Part 261 Subpart C.
5 40 C.F.R. § 260.10 ("Small Quantity Generator means a generator who generates less than 1000 kg of hazardous waste in a calendar month").
680 Fed. Reg. at 58,084 (to be codified at 40 C.F.R. § 266.500).
780 Fed. Reg. at 58,043.
880 Fed. Reg. at 58,087 (to be codified at 40 C.F.R. § 266.505).
980 Fed. Reg. at 58,084 (to be codified at 40 C.F.R. § 266.500).
10See 80 Fed. Reg. at 58,086-87 (to be codified at 40 C.F.R. § 266.503).
1180 Fed. Reg. at 58,015; see also Amendment to the Universal Waste Rule: Addition of Pharmaceuticals, 73 Fed. Reg. 73,520 (Dec. 2, 2008).
1280 Fed. Reg. at 58,087 (to be codified at 40 C.F.R. § 266.508(a)); 80 Fed. Reg. at 59,088 (to be codified at 40 C.F.R. § 266.509(a)(2)).
1380 Fed. Reg. at 58,058.
1480 Fed. Reg. at 58,052; 80 Fed. Reg. at 58,087 (to be codified at 40 C.F.R. § 266.507).
1580 Fed. Reg. at 58,055; 80 Fed. Reg. at 58,087 (to be codified at 40 C.F.R. § 266.507(a)(2)).