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An Update from EPA Academic Labs Rule & Hazardous Waste Pharmaceuticals

An Update from EPA Academic Labs Rule & Hazardous Waste Pharmaceuticals . EPA’s Office of Resource Conservation & Recovery Kristin Fitzgerald. Outline. Part I: Academic Labs Rule (Subpart K) Finalized in 2008 Part II: HW Pharmaceuticals Proposed Rule Under development Questions.

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An Update from EPA Academic Labs Rule & Hazardous Waste Pharmaceuticals

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  1. An Update from EPAAcademic Labs Rule & Hazardous Waste Pharmaceuticals EPA’s Office of Resource Conservation & Recovery Kristin Fitzgerald

  2. Outline • Part I: Academic Labs Rule (Subpart K) • Finalized in 2008 • Part II: HW Pharmaceuticals Proposed Rule • Under development • Questions

  3. Part I: Academic Labs Rule • Overview of Academic Labs Rule • 6 Main Features • Where is the Labs Rule in Effect? • Who is using the Labs Rule? • 3 Mythbusters

  4. Overview • Academia’s Complaint: RCRA generator rules are not a good fit for academic laboratories • Lots of different wastes that vary over time • Small amounts of each waste • Lots of points of generation • Wastes generated by students who have high turnover and lack accountability • EPA’s Response: a sector-based RCRA generator rule for Academic Laboratories to be used in lieu of satellite accumulation area regulations • Part 262 Subpart K

  5. 1. Who Can Use the Labs Rule? • Only “Eligible Academic Entities” may use the Labs Rule: • Colleges & Universities (C/Us) • Teaching Hospitals affiliated with C/Us • Non-profit Research Institutes affiliated with C/Us • Any size generator may use the Labs Rule • CESQGs • SQGs • LQGs • Other labs may not use the Labs Rule: • Government R&D labs • Commercial R&D labs

  6. 2. The Labs Rule is Optional • The Labs Rule is optional on two levels: • States have the option of adopting the rule • Eligible Academic Entities have the option of using the Labs Rule in lieu of satellite accumulation area regulations • Eligible Academic Entities can not opt into using the Labs Rule unless their state has adopted it

  7. 3. Haz. Waste Determinations • Under RCRA, HW Determinations have to be made at the point of generation • Students and PIs that generate the waste in labs lack the expertise needed to make HW determinations • The Academic Labs Rule gives the responsibility for making HW determinations to the EH&S professionals • Lab personnel must give anything that has the potential to be a hazardous waste to EH&S for a HW determination • Labeling is required to allow EH&S to make proper HW determination

  8. 4. Time-Driven Removals • Labs Rule requires hazardous waste to be removed from labs based on time or volume • Every 6 months, regardless of volume • Kept volume limits as a back-up: • More than 55 gallons HW • More than 1 quart of acute HW

  9. 5. Lab Clean-outs • Labs Rule allows each lab to do one clean-out per year (not mandatory) • Hazardous waste from lab clean-outs do not count toward generator status • Hazardous waste from lab clean-outs must be managed as hazardous waste • 30 days to conduct a lab cleanout • This addresses the unintended disincentives of the current program for cleaning out old chemicals

  10. 6. Lab Management Plans • Each eligible academic entity that opts in, must write an LMP with 9 elements: • Part I – 2 elements (enforceable) • Identify choices that the rule requires • Part II – 7 elements (not enforceable) • Describe processes and procedures for how the labs and the EH&S will communicate and manage the laboratory hazardous waste

  11. Where is Labs Rule in Effect?

  12. Other States Adopting • Georgia • Kentucky • Massachusetts • Nevada • New York • Oregon • South Carolina • Tennessee • Texas • Washington

  13. Who is Using the Labs Rule? • 61 Academic Entities have opted to use Subpart K, including • Colleges/Universities • Non-profit Research Institutes • Teaching Hospitals

  14. Mythbusters • MYTH #1: • The Labs Rule is only good for small schools • REALITY: • Nearly 50% of the those that have opted in are LQGs

  15. Mythbusters • MYTH #2: • If you opt into the Labs Rule, you have to comply with more than one RCRA on campus • REALITY: • As EH&S, you probably already do – • Used Oil, Universal Waste, etc. • Your lab workers only have to comply with one RCRA

  16. Mythbusters • MYTH #3: • EPA should have made the rule apply to the entire campus • REALITY: • Other areas of campus do not share the same issues that labs have, so we had no basis for extending the applicability beyond labs

  17. For Detailed Training http://www.epa.gov/multimedia/ORCR/index.html

  18. Part II:HW Pharmaceuticals Proposed Rule • Update on Proposed Rule • Wiki for healthcare professionals to share info on which pharmaceuticals are hazardous waste • Mythbusters

  19. Brief Regulatory History • EPA proposed to add hazardous waste pharmaceuticals to the Universal Waste program in December 2008 • Commenters expressed concern over: • Lack of notification • Lack of tracking/security • EPA decided we could not finalize as proposed and address the commenters’ concerns • EPA is moving forward with a new proposal for sector-specific regulations for the management of hazardous waste pharmaceuticals

  20. New Proposal • Sector-based rulemaking for healthcare facilities and reverse distributors • EPA is building on the Universal Waste proposal • Our approach has been: • Keep aspects of the UW proposal that commenters liked • Address commenters’ concerns • Address new areas that the UW proposal did not

  21. Common Concerns We Hear • Episodic generation due to P-listed hazardous waste • Residues in containers that once held P-listed pharmaceuticals • Flushing pharmaceuticals • Uncertain regulatory status of reverse distributors • Intersection of DEA & EPA regulations

  22. Intersection of DEA & EPA Rules • DEA published a proposed rule to provide disposal options for ultimate users (consumers) of controlled substances on December 21, 2012 • EPA commented on the proposal during interagency review • There are a few hazardous wastes that are also controlled substances • EPA is coordinating with DEA to develop a workable solution

  23. HW Pharmaceuticals Wiki • Healthcare facilities often struggle with determining which drugs in its formulary of thousands of drugs are hazardous waste • EPA created a platform for the healthcare sector to share its expertise with other members of the healthcare sector on which drugs are hazardous wastes – like wikipedia • Anyone can view the material in the wiki • Upon request/approved registration, members of the healthcare community, regulators, etc., can contribute and/or edit the material in the wiki • The wiki is fully searchable by drug name, brand name, waste code, etc

  24. hwpharms.wikispaces.com

  25. Mythbusters • MYTH: • The new proposed rule will regulate ALL waste pharmaceuticals as hazardous waste • REALITY: • If EPA adds pharmaceuticals to the hazardous waste listings or characteristics, that will be a separate rulemaking in the future

  26. QUESTIONS?? • Kristin Fitzgerald • 703-308-8286 • Fitzgerald.Kristin@epa.gov • Academic Labs http://www.epa.gov/waste/hazard/generation/labwaste • Pharmaceuticals http://www.epa.gov/epawaste/hazard/generation/ pharmaceuticals.htm

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