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Ms. Angie Manetti August 2, 2018 Page 2 toward generator status. U.S. EPA added that the weight of the container does not need to be counted toward generator status. CRA's request stems primarily from concern that "counting the weight of these non- empty containers towards generator status almost ensures that many pharmacies will become higher level hazardous waste generators." RATIONALE FOR REGULATORY APPROACH CRA recommends that DTSC follow recent U.S. EPA guidance which °consistently support[s]the intent of the [federal] regulations to only regulate the residue in the container, not the container itself." In reviewing CRA's recommendation, DTSC agrees that U.S. EPA's 2011 memorandum is more consistent with federal hazardous waste regulations applicable to containers. As was stated in that letter, if a container holding an acute hazardous waste is not emptied as specified in 40 Code of Federal Regulations (CFR), section 261.7(b)(3) "... is not considered RCRA empty even though the pharmaceutical is fully dispensed. If the container is not RCRA empty then the residues, [as specified in 40 Code of Federal Regulations, section 261.33(c)] are regulated as hazardous waste." Furthermore, this approach is consistent with other criteria in federal regulations. The federal container requirement states the following in 40 Code of Federal Regulation, section 261.7(a)(2) concerning non-empty containers: `Any hazardous waste in either a container that is not empty or an inner liner removed from a container that is not empty, as defined in paragraph (b) of this section, is subject to regulation underparts 269 through 268, 270 and 924 of this chapter and to the notification requirements of section 3090 of RCRA." Under this requirement, it was not U.S. EPA's intent to regulate the container itself but only the hazardous waste within, i.e., the acute hazardous waste residue remaining in the container. However, DTSC cannot apply the 2011 memorandum in California because it is inconsistent with DTSC's hazardous waste regulations applicable to contaminated containers. When DTSC adopted regulations for contaminated containers, it did not adopt U.S. EPA's approach of addressing only the residues inside the containers. Instead, DTSC adopted container regulations that consider the whole contaminated container hazardous waste and not just the residual inside. California Code of Regulations, title 22, section 66261.7(x) states: