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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 Active h �rmaceutical ± Active: elro� P Di u;g HW ptYckaing type) 'Code inredietit in phraceuti Triple-Rinsed# Iiigpedient In','-,. Pack i>n 3 ar "l�>i a std Nicotine gum* P075 ND ND 0.00005 blisterpack) Nicotine patch* P075 ND 35.8 0.00005 (single use packet Warfarin** P001 ND 6.4 5.0 blisterpack) Physostigmine** P204 ND ND 100 (ampoule) *Method EPA 8720B **HPLC/UV ND =non-detect ii.Large Retailer.The second containers(Le.,100-count)of various detector).The data are summarized in stakeholder that submitted data to EPA dosage strengths of warfarin.The Table 10;the full results submitted to was a large retailer.Their data provide residues were quantified using HPLC— EPA are included in the docket for this the weight of active pharmaceutical UV/Vis(high performance liquid proposed rulemaking(EPA—HQ—RCRA— ingredient residues remaining in bulk chromatography/ultraviolet/visible light 2007-11932). Table 10: Warfarin Residues in 100-Count Dispensing Bottles Number of 'Total War aria Residue AV e Warfarin Bose Warton t n e�ttl j Bottles Tested in all Containers'(mg) Low 1 - 3 m 17 2.638 0.155 Medium 5 -7.5 m 18 12.820 0.712 High 10 m 18 21.530 1.196 The results from each of the first two the high dose of warfarin(10 mg)is Agency(CUPA)Forum Board to stakeholders reflect only the weight of 1.196 mg,if we assume that the residue conduct a study of residues remaining the active pharmaceutical ingredient, in the container has the same in pharmaceutical containers. not the full weight of the hazardous proportions of ingredients(i.e.,5%of Researchers at the University of waste residues. Since it is the Agency's the residue is warfarin and 95% of the California,Riverside(UCR)conducted position that it is the full weight of the residue are other ingredients),then the study and provided their results in hazardous waste residues and not just there would be an average of 23.92 maa report to Riverside County entitled, the weight of the active pharmaceutical of total hazardous waste residue Residue Analysis of P-Listed ingredients that must be counted in remaining in a 100-count bottle of 10 mg Pharmaceutical Containers for Warfarin determining generator status,we have pills of warfarin.The amount of and Nicotine.The results are used the results to calculate the weight hazardous waste residue remaining in a summarized below,but VCR's full of the total residues.In the retailer's 100-count bottle of pills is very small results are in the docket for this case,they have informed EPA that a compared with the residue that would proposed rulemaking(EPA—HCS-RCRA— typical pill with a 10 mg dose of remain in a 55-gallon drum,which is 2007-0932).13° Coumadin(brand name of warfarin) what the regulations for container The intent of the study was to weighs 200 mg.The active ingredient residues envisaged. investigate the third regulatory represents 10 mg,or 5% of the weight iii.Riverside County.The third approach suggested in the November of the pill,while 190 mg,or 95%of the stakeholder that provided data to EPA 2011 memo discussed previously.That weight of the pill,consists of was the Riverside County Department of ingredients other than the active Environmental Health,Hazardous ,ao See Exhibit 2 of the COPA Forum Board Trust ingredient.As indicated in Table 10,the Materials Management Branch.The Fund Grant Report submitted by the Riverside average weight of warfarin residue county received a grant from the County Department of Environmental Health nt the remaining in a frilly dispensed bottle of California Certified Unified Program conclusion of the grant.