Management and Disposal of Hazardous Pharmaceutical Waste

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1 Management and Disposal of Hazardous Pharmaceutical Waste

2 The Defining Regulations Federal- The Defining Regulation 40 CFR Resource Conservation and Recovery Act (RCRA) Federal regulation of the disposal of hazardous wastes Enacted in 1976, Enforced by EPA State of Florida- RULE , FAC. Universal Waste Program Ease the regulatory burden on facilities Pharmaceutical waste that meets the definition of Hazardous waste under RCRA may be managed as :Universal waste Department of Transportation Regulations Governs the transportation of Hazardous Waste

3 What is Hazardous Pharmaceutical Waste?? Any pharmaceutical waste in the form of A solid liquid or gas that can pose a substantial hazard to human health or the environment when not properly managed Defined in 40CFR Part 261 Hazardous waste pharmaceutical means a non-viable pharmaceutical that exhibits a characteristic as described in 40 CFR Part 261, Subpart C or is listed hazardous waste pursuant to 40 CFR Part 261, Subpart D [as defined in paragraphs (4)(i) and (4)(h), F.A.C., respectively]

4 Hazardous Pharmaceutical Waste Classification: Pharmaceutical waste is characterized as hazardous waste if it contains the sole active ingredient of the P or U listed waste, as described in 40 CFR Part 261, or if it exhibits at least one of the following characteristics Ignitability alcohol content greater than 24% and/or flash point greater than 140F hazardous waste number; D001 Toxicity if concentration of chemical above regulatory level in mg/l-hazardous waste number D002 Corrosivity ph less than or equal to 2 or greater than or equal to 12.5-Hazardous waste D003 Reactivity oxidizer, water reactive, air reactive-hazardous waste D004-D0043

5 Why Now?? Increased EPA investigations and enforcements Corporate fines: $27,500 per violation per day Environmental Impact Human health and the environment Social Responsibility

6 Increasing US EPA Regulatory Activity EPA Region 2 (NY, NJ, Puerto Rico, US Virgin Islands) contacted 480 hospitals in 2003; Rx waste included. Region 2 Website: North Shore University Hospital, Manhasset, NY fined $40,000 (July 2003) Nassau University Medical Center, East Meadow, NY fined $279,900 (Oct. 2003) Mountainside Hospital, Montclair, NJ fined $64,349 (Nov. 2003) Memorial Sloan Kettering Cancer Center, New York, NY, fined $214,420

7 Environmental Impact Here are only a few examples of the effect pharmaceutical waste has on our environment: Estrogens have caused some male fish species to become female Antidepressants have augmented aggressive behavior in lobsters Prozac has stimulated shellfish reproduction A study published in the Environmental Science and Technology journal found that at environmental exposure levels (ng/l), a mix of 13 common medications seen in drinking water inhibited the growth of human embryonic cells 2002 U.S. Geological Survey sampled 139 streams in 30 states. 80% or 111 of the 139 streams had measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones. Kreisberg, Joel. "There is Medicine in These Waters." THE JOURNAL OF ECOLOGICALLY SUSTAINABLE MEDICINE (2006): Telosis. < Pomati F, Castiglioni S, Zuccato E, Fanelli R, Vigetti D, Rossetti C, Calamari D. Effects of a complex mixture of therapeutic drugs at environmental levels on human embryonic cells. Environmental science & Technololgy. 2006;40(7):

8 HAZARDOUS DRUGS FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS) Pharmaceutical Waste Cycle Regular Landfill (Non-Hazardous Landfill) CHEMO TRACE WASTE - SHARPS MEDICAL WASTE INCINERATOR LINED HAZARDOUS WASTE LANDFILL NON-HAZARDOUS LANDFILL LEACHATE INTO ENVIRONMENT RED SHARPS AUTOCLAVE/ MICROWAVE VS Lined Landfill (Hazardous Landfill) SOLID or NON- HAZARDOUS WASTE NON-HAZARDOUS LANDFILL NON-HAZARDOUS LANDFILL LEACHATE INTO ENVIRONMENT LEACHATE INTO ENVIRONMENT

9 Tools to Assist Staff Badge Buddy Black Bin Poster Side 1 Instructional posters will be posted to assist staff Side 2 A colored coded disposal guide badge will be provided

10 QUESTIONS WELCOMED

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