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

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

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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 ... – PowerPoint PPT presentation

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


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
Reduces barriers 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 lt/ 5000 kg/mth
  • Accumulate 1 year
  • Large quantity gt 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
  • Dont 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
Whats 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_at_floridadep.net
  • Mike Redig, Tallahassee
  • (850) 245-8774 S/C 205-8774
  • michael.redig_at_floridadep.net
  • Leah Proffitt, Orlando
  • (407) 893-3323 S/C 325-2283
  • leah.proffitt_at_floridadep.net
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