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ROGERS ,JOSEPH O'DONNELL www.rjo.com Elianna Florido, REHS San Joaquin County Environmental Health Dept. July 24, 2020 Page 3 is listed as an acute waste, the miniscule amount of residue, if any, determined through testing, shows it would take millions of bottles to make 1 lb. of residue. What each DTSC letter does state is that California does not agree with U.S. EPA's approach in not managing these empty bottles as hazardous waste, and that"DTSC will review this issue again when U.S. EPA's rules for pharmaceutical wastes are promulgated." Those rules were promulgated long ago, and U.S. EPA was very clear,based on its own and other studies that there was no basis for managing empty warfarin containers as hazardous waste or counting their weight toward generator status. U.S. EPA's rule re "empty containers" states at 40 CFR 266.507(a): Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container(e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container. (italics added). EPA's response to a comment from the rulemaking process also highlights its position: One commenter asked us to add an explicit reference to acute/P-listed hazardous waste in this section of the regulations. We believe this is unnecessary since § 261.7(c) indicates that containers of hazardous waste pharmaceuticals (which includes acute and non-acute hazardous waste pharmaceuticals) are subject to § 266.507 in lieu of§ 261.7 for determining when they are empty. Nevertheless, we agree with the commenter that all of the new empty container provisions in § 266.507 apply to containers that held either non-acute or acute hazardous waste pharmaceuticals. Under the new subpart P provisions, for containers that once held non-acute waste pharmaceuticals to be considered empty, it will not be necessary to measure the remaining contents, and for containers that once held acute hazardous waste pharmaceuticals, it will not be necessary to triple-rinse the containers or demonstrate an equivalent removal method. (emphasis added). In promulgating this rule, U.S. EPA conducted its own study as well as a review of the testing submitted by at least 3 other stakeholders to arrive at its conclusion that empty warfarin stock bottles are exempt from handling as hazardous waste. If the residue is insufficient 514077.1 A Professional Law Corporation