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

3. 1. Overview of Academic Labs Rule 2. 6 Main Features 3. Where is the Labs Rule in Effect? 4. Who is using the Labs Rule? 5. 3 Mythbusters 3

4.  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 4

5.  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 5

6.  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 6

7.  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 7

8.  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 8

9.  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 9

10.  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 10

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12. 1. Georgia 2. Kentucky 3. Massachusetts 4. Nevada 5. New York 6. Oregon 7. South Carolina 8. Tennessee 9. Texas 10. Washington 12

13.  61 Academic Entities have opted to use Subpart K, including › Colleges/Universities › Non-profit Research Institutes › Teaching Hospitals 13

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

15.  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 15

16.  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 16

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

18. 1. Update on Proposed Rule 2. Wiki for healthcare professionals to share info on which pharmaceuticals are hazardous waste 3. Mythbusters 18

19.  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 19

20.  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 20

21.  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 21

22.  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 22

23.  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 23

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25.  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 25

26.  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 26