an update from epa academic labs rule & hazardous waste pharmaceuticals
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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. - PowerPoint PPT PresentationTRANSCRIPT
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An Update from EPAAcademic Labs Rule &
Hazardous Waste Pharmaceuticals EPA’s Office of Resource Conservation & Recovery
Kristin Fitzgerald
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Outline Part I: Academic Labs Rule (Subpart K)
› Finalized in 2008
Part II: HW Pharmaceuticals Proposed Rule› Under development
Questions
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Part I: Academic Labs Rule
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
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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
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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
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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
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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
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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
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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
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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
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Where is Labs Rule in Effect?
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Other States Adopting1. Georgia 2. Kentucky3. Massachusetts4. Nevada5. New York6. Oregon7. South Carolina8. Tennessee9. Texas10. Washington
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Who is Using the Labs Rule? 61 Academic Entities have opted to use
Subpart K, including› Colleges/Universities› Non-profit Research Institutes› Teaching Hospitals
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Mythbusters MYTH #1:
› The Labs Rule is only good for small schools
REALITY: › Nearly 50% of the those that have opted in
are LQGs
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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
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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
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For Detailed Training
http://www.epa.gov/multimedia/ORCR/index.html
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Part II:HW Pharmaceuticals Proposed Rule
1. Update on Proposed Rule
2. Wiki for healthcare professionals to share info on which pharmaceuticals are hazardous waste
3. Mythbusters
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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
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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
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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
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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
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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
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hwpharms.wikispaces.com
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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
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QUESTIONS?? Kristin Fitzgerald
› 703-308-8286› [email protected]
Academic Labshttp://www.epa.gov/waste/hazard/generation/labwaste
Pharmaceuticalshttp://www.epa.gov/epawaste/hazard/generation/pharmaceuticals.htm