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

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

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

1. Georgia 2. Kentucky3. Massachusetts4. Nevada5. New York6. Oregon7. South Carolina8. Tennessee9. Texas10. 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

1. Update on Proposed Rule

2. Wiki for healthcare professionals to share info on which pharmaceuticals are hazardous waste

3. 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 Labshttp://www.epa.gov/waste/hazard/generation/labwaste

Pharmaceuticalshttp://www.epa.gov/epawaste/hazard/generation/pharmaceuticals.htm