Comment submitted by Robert Luther, United States Department of Defense, Department of the Army

Comments submitted by Army Department as Executive Agent for the Department of Defense Hazardous Waste Committee “Amendment to the Universal Waste Rules, Addition of Pharmaceuticals” Proposed Rule December 2, 2008, 73 FR 73519 Docket ID: EPA-HQ-RCRA-2007-0932 1. Requirements for Pharmaceutical Universal Waste Take-back Program Accumulation Points Comment. EPA should add regulatory language to the rule that allows handlers of pharmaceutical universal wastes to establish collection points for patients and consumers to bring their unused drugs for accumulation and disposal, where the universal waste handler would not be expected to keep records of universal waste received from households. Discussion. EPA requests comment on what effect this regulation might have on community take-back programs (73 FR 73526). Department of Defense hospitals, clinics, and pharmacies that might offer such a program are often regulated as large quantity generators of hazardous waste and large quantity handlers of universal wastes, due to their location within a larger installation’s fence line. Because of their own pharmaceutical waste generation, it would be difficult and cumbersome to demonstrate a household hazardous waste exclusion for the portion of the pharmaceutical waste from households, and yet apply universal waste rules to non-household pharmaceutical waste that is generated onsite. It is our experience that a household hazardous waste exclusion often may not be applied to community hazardous waste turn-in type programs. To avoid the possibility for uncertainty in enforcement, it would be helpful if EPA were to clarify that this rule allows establishing accumulation points and does not require recordkeeping to track individual contributions of waste pharmaceuticals turned-in during a community pharmaceutical universal waste take-back program. EPA also requests comment on whether accumulation containers need to be covered. In the case of a turn-in program, the container should be under the direct control of the accumulation point operator, such as a pharmacist, or have a lid that prevents retrieval of items added to the container. Recommendation. EPA should add regulatory language to the rule that allows handlers of pharmaceutical universal wastes to establish collection points for patients and consumers to bring their unused or partially-used drugs for accumulation and disposal, where the universal waste handler would not be required to keep records of universal waste received from these households.   2. Sorting by and Listing of Waste Codes on Accumulation Container Comment. To simplify the accumulation of pharmaceutical universal wastes, we recommend that neither sorting by nor listing of individual waste codes on the accumulation container be required. Discussion. EPA requests comment on whether sorting and/or the listing of individual waste codes should be required for universal waste pharmaceuticals (73 FR 73535 & 73536). We believe these additional requirements would be overly burdensome for the regulated community while providing minimal environmental benefits. A review of the treatment standards in 40 CFR 268 indicates that, for the waste pharmaceuticals currently generated within the Department of Defense, the treatment standards are either combustion or a numeric standard. Since these items can all be permissibly treated by incineration, there would appear to be little benefit in requiring additional segregation and waste code labeling. Recommendation. Do not require sorting by or listing of waste codes on accumulation containers of pharmaceutical universal wastes.