1

Part I: Academic Labs Rule (Subpart K)
› Finalized in 2008

Part II: HW Pharmaceuticals Proposed
Rule
› Under development

Questions
2
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

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

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

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




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

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

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

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
11
1. Georgia
2. Kentucky
3. Massachusetts
4. Nevada
5. New York
6. Oregon
7. South Carolina
8. Tennessee
9. Texas
10. Washington
12

61 Academic Entities have opted to use
Subpart K, including
› Colleges/Universities
› Non-profit Research Institutes
› Teaching Hospitals
13

MYTH #1:
› The Labs Rule is only good for small schools

REALITY:
› Nearly 50% of the those that have opted in
are LQGs
14

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

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
http://www.epa.gov/multimedia/ORCR/index.html
17
1.
Update on Proposed Rule
2.
Wiki for healthcare professionals to share
info on which pharmaceuticals are
hazardous waste
3.
Mythbusters
18

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

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
Episodic generation due to P-listed
hazardous waste
 Residues in containers that once held Plisted pharmaceuticals
 Flushing pharmaceuticals
 Uncertain regulatory status of reverse
distributors
 Intersection of DEA & EPA regulations

21

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





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
24

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

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