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Universal Waste Rule for Pharmaceuticals 62-730.186 F.A.C.

Universal Waste Rule for Pharmaceuticals 62-730.186 F.A.C. What Is ‘Universal Waste’?. Generated in large quantities Found in variety of industries 40 CFR Part 273. Examples. Fluorescent lamps Mercury thermostats Batteries Recalled pesticides. Why Drugs?. Wide variety of generators:

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Universal Waste Rule for Pharmaceuticals 62-730.186 F.A.C.

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  1. Universal Waste Rule for Pharmaceuticals 62-730.186 F.A.C.

  2. What Is ‘Universal Waste’? • Generated in large quantities • Found in variety of industries • 40 CFR Part 273

  3. Examples • Fluorescent lamps • Mercury thermostats • Batteries • Recalled pesticides

  4. Why Drugs? • Wide variety of generators: • Fire stations • Small drugstores • Warehouses • Large hospitals

  5. How does it work? • Alternative set of standards • Regulatory flexibility vs. 40 CFR Parts 260-272…

  6. Reducesbarriers to collection • Small quantity handler: 5000 kg • SQG: 1000 kg • Longer accumulation time

  7. Reduces complexities • Waste Management • Accumulation time • Off-site shipments • Tracking

  8. Reduces cost of compliance • Increased accumulation times • Relaxed standards

  9. A look at the Rule… • Applies to H/W drugs (“viable”) • Requires documented credit • Mfg • RD • Charities

  10. Handler requirements • Small quantity: </= 5000 kg/mth • Accumulate 1 year • Large quantity: > 5000 kg/mth • Accumulate 6 mos • Amounts are cumulative • EPA ID number • Proper container mgmt.(label, compatible) • Training

  11. Reverse Distributors • H/W Generators • Begin waste determination w/in 24 hrs • Complete process in 10 days • Keep record • Date of receipt • Date determined hazardous waste

  12. Documentation is key!

  13. Labpacks • Handler may: • Sort/mix compatible drugs • Consolidate • Remove drugs from consumer packaging • Manage any resulting wastes

  14. Employee Training • Waste mgmt. relevant to position • Contingency Plan • 3-month window • Annual review • Document (3 years)!

  15. Off-site shipments • Destination facility (40 CFR 273.9) • RD: permitted HW disposal facility • Self-transport • DOT requirements • Documentation (3 years)

  16. Acceptance of shipments • Written agreement w/ destination facility • Rejected shipments: • Receive waste back, or • Alternate facility • Receipt of non-UW haz waste: • Notify DEP • Manage pursuant to Ch 62-730 F.A.C.

  17. Comments… problems identified

  18. “Viable” • No prior knowledge of final disposition • Mfg. policies vary widely • Don’t always cover returns • Deduct from invoice vs credit return • Current wording increases waste

  19. Definitions • “Container” • Not intended for ingestion, absorption, etc. • “Consumer packaging” • Intended for retail/household environment

  20. Waste determination • 24 hrs/10 days • Allow for business fluctuation • 20 days; no start time

  21. What’s next? • Workshop in early February • Public notice in January • Final Rule in April • Effective in July

  22. Contacts • Agusta Posner, Tallahassee (850) 245-2282 S/C 205-2282 augusta.posner@floridadep.net • Mike Redig, Tallahassee (850) 245-8774 S/C 205-8774 michael.redig@floridadep.net • Leah Proffitt, Orlando (407) 893-3323 S/C 325-2283 leah.proffitt@floridadep.net

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