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Federal Register/Vol. 80, No. 186/Friday, September 25, 2015/Proposed Rules 58053 Table 9: Active Pharmaceutical Ingredient in Residues in Single -Unit Dose Packaging *Method EPA 8720B * *BPLC/UV ND = non -detect ii. Large Retailer. The second stakeholder that submitted data to EPA was a large retailer. Their data provide the weight of active pharmaceutical ingredient residues remaining in bulk containers (i.e., 100 -count) of various dosage strengths of warfarin. The residues were quantified using HPLC— UV/Vis (high performance liquid chromatography/ultraviolet/visible light detector). The data are summarized in Table 10; the full results submitted to EPA are included in the docket for this P Table 10: Warfarin Residues in 100 -Count Dispensing Bottles rulemaking (EPA—HQ—RCRA- 2007-0932). a DragiW��1�ql PAS �- d{t' en, 1 'r i 'YS i `rad�iiitt` Low 1' - 3 m %��{ 2.638 0.155 Medium 5 - 7.5 m 18 kfll'{;�W 0.712 Hi h 10 m 18 21.530 1.196 { r Nicotine gum* P075 ND ND 0.00005 blisterpack) Nicotine patch* P075 ND 35.8 0.00005 (single usepacket) Warfarin* * pool ND 6.4 5.0 blisterpack) Physostigmine** p204 ND ND 100 (ampoule) *Method EPA 8720B * *BPLC/UV ND = non -detect ii. Large Retailer. The second stakeholder that submitted data to EPA was a large retailer. Their data provide the weight of active pharmaceutical ingredient residues remaining in bulk containers (i.e., 100 -count) of various dosage strengths of warfarin. The residues were quantified using HPLC— UV/Vis (high performance liquid chromatography/ultraviolet/visible light detector). The data are summarized in Table 10; the full results submitted to EPA are included in the docket for this P Table 10: Warfarin Residues in 100 -Count Dispensing Bottles rulemaking (EPA—HQ—RCRA- 2007-0932). The results from each of the first two stakeholders reflect only the weight of the active pharmaceutical ingredient, not the full weight of the hazardous waste residues. Since it is the Agency's position that it is the full weight of the hazardous waste residues and not just the weight of the active pharmaceutical ingredients that must be counted in determining generator status, we have used the results to calculate the weight of the total residues. In the retailer's case, they have informed EPA that a typical pill with a 10 mg dose of Coumadin (brand name of warfarin) weighs 200 mg. The active ingredient represents 10 mg, or 5% of the weight of the pill, while 190 mg, or 95% of the weight of the pill, consists of ingredients other than the active ingredient. As indicated in Table 10, the average weight of warfarin residue remaining in a fully dispensed bottle of i (10 mg) the high dose of warfarn is 1.196 mg. If we assume that the residue in the container has the same proportions of ingredients (i.e., 5% of the residue is warfarin and 95% of the residue are other ingredients), then there would be an average of 23.92 mg of total hazardous waste residue remaining in a 100 -count bottle of 10 mg pills of warfarin. The amount of hazardous waste residue remaining in a 100 -count bottle of pills is very small compared with the residue that would remain in a 55 -gallon drum, which is what the regulations for container residues envisaged. iii. Riverside County. The third stakeholder that provided data to EPA was the Riverside County Department of Environmental Health, Hazardous Materials Management Branch. The county received a grant from the County California Certified Unified Program conduct a study of residues remaining in pharmaceutical containers. Researchers at the University of California, Riverside (UCR) conducted the study and provided their results in a report to Riverside County entitled, Residue Analysis of P -Listed Pharmaceutical Containers for Warfarin and Nicotine. The results are summarized below, but VCR's full results are in the docket for this proposed rulemaking (EPA—HQ—RCRA- 2007-0932).130 The intent of the study was to in Agency (CUPA) Forum Board to the third regulatory approach suggested in the November 2011 memo discussed previously. That iao See Exhibit 2 of the CUPA Forum Board Trust Fund Grant Report submitted by the Riverside Department of Environmental Health at the Co of the grant. �- W{�#1Wttzt��.7� 'YS Low 1' - 3 m 17 2.638 0.155 Medium 5 - 7.5 m 18 12.820 0.712 Hi h 10 m 18 21.530 1.196 The results from each of the first two stakeholders reflect only the weight of the active pharmaceutical ingredient, not the full weight of the hazardous waste residues. Since it is the Agency's position that it is the full weight of the hazardous waste residues and not just the weight of the active pharmaceutical ingredients that must be counted in determining generator status, we have used the results to calculate the weight of the total residues. In the retailer's case, they have informed EPA that a typical pill with a 10 mg dose of Coumadin (brand name of warfarin) weighs 200 mg. The active ingredient represents 10 mg, or 5% of the weight of the pill, while 190 mg, or 95% of the weight of the pill, consists of ingredients other than the active ingredient. As indicated in Table 10, the average weight of warfarin residue remaining in a fully dispensed bottle of i (10 mg) the high dose of warfarn is 1.196 mg. If we assume that the residue in the container has the same proportions of ingredients (i.e., 5% of the residue is warfarin and 95% of the residue are other ingredients), then there would be an average of 23.92 mg of total hazardous waste residue remaining in a 100 -count bottle of 10 mg pills of warfarin. The amount of hazardous waste residue remaining in a 100 -count bottle of pills is very small compared with the residue that would remain in a 55 -gallon drum, which is what the regulations for container residues envisaged. iii. Riverside County. The third stakeholder that provided data to EPA was the Riverside County Department of Environmental Health, Hazardous Materials Management Branch. The county received a grant from the County California Certified Unified Program conduct a study of residues remaining in pharmaceutical containers. Researchers at the University of California, Riverside (UCR) conducted the study and provided their results in a report to Riverside County entitled, Residue Analysis of P -Listed Pharmaceutical Containers for Warfarin and Nicotine. The results are summarized below, but VCR's full results are in the docket for this proposed rulemaking (EPA—HQ—RCRA- 2007-0932).130 The intent of the study was to in Agency (CUPA) Forum Board to the third regulatory approach suggested in the November 2011 memo discussed previously. That iao See Exhibit 2 of the CUPA Forum Board Trust Fund Grant Report submitted by the Riverside Department of Environmental Health at the Co of the grant.