Source: https://www.khlaw.com/8435
Timestamp: 2019-04-24 12:29:51+00:00

Document:
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.
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.
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 walker@khlaw.com, or Greg Clark at (202) 434-4302 or clarkg@khlaw.com.
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)).

References: § 6901
 § 261
 § 266
 § 260
 § 266
 § 266
 § 266
 § 266
 § 266
 § 266
 § 266
 § 266