Pharmaceutical Waste Management: Compliance for...

79
The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10. Presenting a live 90-minute webinar with interactive Q&A Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities Leveraging Recent Environmental Enforcement Actions and Understanding Policy Shifts to Ensure Regulatory Compliance Today’s faculty features: THURSDAY, JULY 30, 2015 Gregory W. Blount, Partner, Troutman Sanders, Atlanta Charlotte A. Smith, Senior Regulatory Advisor, WMSS PharmEcology Services, Houston Darrell J. Oman, Program Manager Consulting Services, Stericycle Environmental Solutions, Blaine, Minn. 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

Transcript of Pharmaceutical Waste Management: Compliance for...

The audio portion of the conference may be accessed via the telephone or by using your computer's

speakers. Please refer to the instructions emailed to registrants for additional information. If you

have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

Presenting a live 90-minute webinar with interactive Q&A

Pharmaceutical Waste Management:

Compliance for Hospitals, Pharmacies,

and Other Healthcare Facilities Leveraging Recent Environmental Enforcement Actions

and Understanding Policy Shifts to Ensure Regulatory Compliance

Today’s faculty features:

THURSDAY, JULY 30, 2015

Gregory W. Blount, Partner, Troutman Sanders, Atlanta

Charlotte A. Smith, Senior Regulatory Advisor, WMSS PharmEcology Services, Houston

Darrell J. Oman, Program Manager – Consulting Services, Stericycle Environmental Solutions,

Blaine, Minn.

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

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Pharmaceutical Waste Management:

Compliance for Hospitals, Pharmacies, and

Other Healthcare Facilities

Gregory W. Blount, Esq., Troutman Sanders LLP

Charlotte A. Smith, R. Ph., M.S., WM Sustainability Services, PharmEcology Services

Darrell J. Oman, Stericycle Environmental Solutions

July 30, 2015

Gregory W. Blount

Troutman Sanders LLP [email protected]

Pharmaceutical Waste Management

6

Roadmap

7

Resource Conservation and Recovery Act

(RCRA) Basics

What is pharmaceutical waste?

Why are regulators concerned?

How do RCRA and state programs cover this

waste?

Recent Enforcement

Federal and state reform efforts

RCRA Basics

Congress Enacted in 1976

Governs disposal of solid waste and hazardous waste; encourages waste minimization

Drafted for industrial facilities, but applicable to medical facilities and retail pharmacies.

Two types of Hazardous Waste: Characteristic – exhibit one of four traits

Toxicity, Ignitability, Reactivity, Corrosivity

Listed Wastes: P List (acute) and U List (toxic)

Regulated from Point of Generation through point of ultimate disposal.

8

What is Pharmaceutical Waste?

May include dropped pills, compounding chemicals,

Warfarin containers, expired Tylenol, nicotine

replacement therapy, IV bags, vials, spill cleanup

materials, medicated shampoo and cough drops

Regulated by U.S. EPA and U.S. DEA

Small amount are RCRA Hazardous Waste

States may consider additional pharmaceuticals as

hazardous waste (e.g., MN Lethality)

CA Medical Waste Management Act

“Medical waste” includes OTCs

9

Why Are Regulators Concerned with

Pharmaceutical Waste? Why Now?

New focus on drugs in the water supply (E.g., 2008

Associated Press Study; USGS Studies)

Nicotine replacement therapy waste triggers LQG

registration and heightened scrutiny

Significant enforcement precedent in California and

Connecticut

U.S. EPA foot-dragging on RCRA reform and drug risk

assessment per Inspector General

RCRA ill-suited for retail and many health care

providers (“Square peg in a round hole”)

10

EPA Regulation of

Hazardous Waste Pharmaceuticals

Managed under RCRA or more stringent state program

2008: U.S. EPA proposed to add hazardous waste pharmaceuticals to the

Universal Waste rule

“Universal Waste”: a subset of Hazardous Waste that have

streamlined management standards.

2012: U.S. EPA rescinded the 2008 proposal

Lack of tracking for shipments of hazardous waste pharmaceuticals

Lack of notification by most handlers managing hazardous waste

pharmaceuticals

May 2012: Office of Inspector General recommended EPA establish a

process for reviewing whether pharmaceuticals are hazardous waste.

Expected Summer 2015: New U.S. EPA proposed rule related to

hazardous waste pharmaceuticals

11

Patchwork of State Requirements

States are not always consistent with U.S. EPA

Some have adopted U.S. EPA guidance and exemptions; others have not

E.g., “empty” containers do not count toward generator status

Reverse Distribution Policies

E.g., NM and MN

State-specific requirements

E.g., Waste Determinations

E.g., CA-only Toxics; CA Medical Waste Management Act

State Universal Pharmaceutical Waste Rules

Florida and Michigan

12

Point of Generation Issues

Waste Determination: If a pharmaceutical is a “waste,” the generator must determine whether it is hazardous.

When does a pharmaceutical become a waste?

At the retailer? At the Reverse Distribution facility?

Confusion and risk for Retailers’ using Reverse Distribution for prescription pharmaceuticals

If Nondispensed Pharmaceuticals Qualify for Reverse Distribution Procedures:

Not subject to hazardous waste regulations

If Pharmaceuticals do not Qualify for Reverse Distribution:

Pharmaceutical waste must be managed as hazardous waste (storage, transportation, disposal, etc.)

13

Point of Generation Issues

U.S. EPA’s “position” – Not binding

Pharmaceutical products returned through reverse

distribution do not become “wastes” until a determination

is made to discard them.

States are Inconsistent

Most appear to embrace U.S. EPA’s position

Some are more stringent

E.g., Minnesota; New Mexico; Colorado

14

Point of Generation – Inconsistent Policies

15

Point of Generation – Inconsistent Policies

16

Point of Generation – Inconsistent Policies

17

RCRA Enforcement –

Common Misconception

18

RCRA Enforcement: Who is Liable?

Hospitals; Retail Pharmacies; Retail Groceries;

Manufacturers; Wholesalers; Reverse Distributors;

Clinics; Surgery Centers; Veterinary Practices; Long

term care facilities

Federal and State liability

Criminal and Civil liability

U.S. EPA fines: Up to $37,500 violation/day.

Potential Debarment or Suspension

19

Wal-Mart Plea Agreement

U.S. DOJ in California and Missouri announced on May

28, 2013

Totaled $81 million

Investigation began in approx. 2006

Investigation focused primarily on retail and

pharmaceutical hazardous waste mismanagement

Retail Industry Leaders Association (RILA) Outreach

20

Retail Enforcement Cases

21

Retail Enforcement Cases

22

Recent CA Hazardous Waste Enforcement Activity

at Retail Facilities

DATE OF

SETTLEMENT

COMPANY NUMBER OF

LOCATIONS

PENALTY

4/3/2013 Save Mart Supermarkets 256 $2,550,000 ($9,961 per facility)

6/5/2013 Winco Foods 38 $375,000 ($9,868 per facility)

9/24/2013 Rite-Aid 590 $12,324,000 ($20,888 per facility)

6/4/2014 Albertsons 188 $3,387,000 ($18,016 per facility)

8/15/2014 Raley’s 145 $1,599,000 ($11,028 per facility)

12/30/2014 99 Cents Only Stores 251 $2,362,500 ($9,412 per facility)

1/02/2015 Safeway 575 $9,870,000 ($17,165 per facility)

4/24/2015

Dollar Tree 512 $2,720,000 ($5,313 per facility)

23

Recent Hazardous Waste Enforcement

Activity at Healthcare Facilities

Concord Hospital, Concord, NH fined $205,000 by NH

Department of Environmental Services in December 2014.

Aurora Health Care, Milwaukee, WI settled hazardous waste

case for $340,000 in May 2014.

SUNY Downstate Medical Center, Brooklyn, NY fined

$156,710 by U.S. EPA in August 2014.

Danbury Hospital, Danbury, CT fined $41,855 by CT

Department of Energy and Environmental Protection in

September 2012.

Sentara Norfolk General Hospital, VA settled with U.S. EPA

for $19,920 in May 2012.

24

Current Reform Efforts

Retailers and Healthcare are hopeful RCRA

reform will provide clarity.

Current reform efforts include:

Generator rule change

Pharmaceutical waste reform

Retail waste reform

California Medical Waste Management Act

25

Important Issues Noted by U.S. EPA as

Expected for EPA’s Proposed Rule

Regulatory status of creditable pharmaceuticals

Point of generation

LQG status due to P-listed hazardous waste

Better fix for containers with P-listed pharmaceutical

residues

Intersection of U.S. EPA and U.S. DEA regulations

26

Operationalizing the DEA and EPA Compliance Challenges Charlotte A Smith, R. Ph., M.S.

WM Sustainability Services,

PharmEcology Services

Pharmaceutical Waste Management:

Compliance for Hospitals, Pharmacies,

and Other Healthcare Facilities

July 30th, 2015

Legal Disclaimer

This course is solely for educational purposes and provides only

a general description of various regulatory requirements. For a

complete description, please consult the relevant federal and

state regulatory statutes. Nothing in this presentation

constitutes legal advice and you should not legally rely on any

information provided in this presentation. We make no

warranty, express or implied, with respect to such information

and disclaim all liability resulting from any use or reliance of

this information.

© 2015 WM National Services, Inc.

28

Drug Enforcement Administration

• Stocking, dispensing, and disposing of controlled substances

involves a high level of risk and regulation, as defined under

the Controlled Substances Act (CSA)

• Healthcare facilities and pharmacies are registered with the

DEA as “registrants” and must meet a variety of security and

documentation requirements

• During the medication administration process in a hospital,

ambulatory surgery center (ASC), or other medical clinic, it is

common for “wastage” of controlled substances to occur

• Such wastage is usually documented in an automated

dispensing cabinet at hospitals and may be documented

manually in the ASC or clinic environment

• Retail pharmacies usually do not generate controlled

substance waste but may have outdated controlled substances

that must be managed through reverse distribution

©2015 WM National Services, Inc. 29

The CSA Regulates Drugs of Abuse into Five Schedules Schedule I: Illegal substances not recognized for medical use, e.g.

heroin, LSD, psilocybin, mescaline

Schedule II: medically available under strict controls, high

potential for abuse leading to severe psychological or physical

dependence e.g. oxycodone, fentanyl, morphine, codeine,

amphetamine. Designated as CII on label.

Schedule III: medically available under somewhat less strick controls,

moderate or low physical dependence, high psychological

dependence e.g. codeine combination products, thiopental, anabolic

steroids. Designated as CIII.

Schedule IV: medically available, low potential for abuse, e.g.

Xanax®, Tranzene®, Valium®, Versed®, Halcion® Designated as CIV.

Schedule V: Low potential for abuse and limited concentrations of

narcotics e.g. codeine cough syrups. Designated as CV.

©2015 WM National Services, Inc.

30

The New DEA Disposal Regulation

• Published September 9th, 2014; took effect October 9th,

2014

• Requirements to govern the secure disposal of controlled

substances by both DEA registrants and ultimate users

• Regulations implement the Secure and Responsible Drug

Disposal Act of 2010

• Expands options for take-back events

• Creates mail-back programs and collection receptacle

locations

• Reorganizes and consolidates regulations on disposal

and role of reverse distributors

© 2015 WM National Services, Inc.

31

Healthcare Sectors Impacted by DEA Rule Changes • Registrant Disposal

• Hospitals, clinics, physicians, veterinarians, dentists

• Retail Pharmacies including LTCF Provider Pharmacies

• Reverse Distributors

• Non-Registrant Disposal

• “Ultimate User” collection programs, including law enforcement

– Mail-back

– Receptacles (kiosks)

– Single day events

• “Ultimate User” long term care facilities (LTCFs)

– Receptacles provided and managed by retail pharmacies

© 2015 WM National Services, Inc.

32

Definition of Terms Disposal and dispose: to refer generally to the wide range

of activities that result in CS being unavailable for further

use or one entity ridding themselves of such substances

(e.g., returns). (FR53547 col 2)

A controlled substance can be “disposed of” by

destruction, return, recall, sale, or through the

manufacturing process.

The new rule eliminates the authority of the Special Agent

in Charge (SACs) to individually authorize disposal methods

for non-practitioners, and retains this option for

practitioners (1317.05)

© 2015 WM National Services, Inc.

33

Definition of Terms 1300.05 Methods of Destruction (FR 53522 col1): Intention to allow

public and private entities to develop a variety of

destruction methods that are secure, convenient, and

responsible. Must also meet all other applicable Federal,

State, tribal and local laws and regulations. Once “non-

retrievable,” no longer subject to DEA regulations.

Supersedes all existing MOAs and MOUs.

Retains ability for practitioners to request assistance from

the local special Agent in Charge (SAC). (1317.05(a)(5)).

© 2015 WM National Services, Inc.

34

Definition of Terms 1300.05 Non-retrievable: the condition or state to which a

controlled substance shall be rendered following a process

that permanently alters that controlled substance’s

physical or chemical condition or state through

irreversible means and thereby renders the controlled

substance unavailable and unusable for all practical

purposes.

Cannot be transformed to a physical or chemical condition

or state as a controlled substance or controlled substance

analogue.

© 2015 WM National Services, Inc.

35

Definition of Terms Destruction (1317.90): Must be rendered non-retrievable.

Incineration is the ONLY method currently accepted by

DEA. Sewering and landfill disposal (mixing with kitty

litter, etc.) do not meet non-retrievable standard.

(FR53547 col 3)

The healthcare industry expressed serious concerns about

how to meet this definition.

DEA issued a clarification letter exempting administered

medications from the new rule.

© 2015 WM National Services, Inc.

36

Registrant Disposal Concerns Expressed to DEA

• Ability to render a drug “non-retrievable” in an

institutional setting

• Ability to transfer drug wastage to a reverse distributor

from an institutional setting

• Requirement to double witness the destruction of the CS until

it is rendered non-retrievable

© 2015 WM National Services, Inc.

37

DEA Clarification Letter: October 17, 2014 • “…once a controlled substance has been dispensed to a patient by

an institutional practitioner on the basis of an order for immediate

administration to a patient at the registrant's registered location,

the substance is no longer in the practitioner's inventory. For

example, after a pre-filled syringe or a single-dose vial or syringe is

administered to a patient, any remaining substance in the syringe or

vial is not required to be destroyed in accordance with new Part

1317.”

• Such wastage cannot be disposed in a receptacle for ultimate user

collection

• Controlled substances from the pharmacy’s inventory cannot be

disposed in a receptacle for ultimate user collection.

• All destruction must be in accordance with Federal, State, tribal,

and local laws and regulations

© 2015 WM National Services, Inc.

38

DEA Clarification Letter: October 17, 2014

• “Although Part 1317 does not apply to pharmaceutical

wastage, the DEA strongly encourages all practitioners to

continue to adhere to security controls and procedures

that ensure pharmaceutical wastage is not diverted.

For example, most institutional practitioners have

implemented policies that require two persons to

witness and record destruction of pharmaceutical

wastage.”

• http://www.deadiversion.usdoj.gov/drug_disposal/dear

_practitioner_pharm_waste_101714.pdf

© 2015 WM National Services, Inc.

39

Disposal Options for Controlled Substance Waste

• VERY few controlled substances are EPA hazardous waste

• Chloral hydrate U034

• Alcoholic formulations: diazepam injection, undiluted

• Consider using a method for discouraging diversion

• Cactus Smart Sink®

• Activated carbon options

• DO NOT dispose in regular trash

• Pharmaceutical waste – usually non-hazardous

• Drain dispose if permitted by state and local publicly owned

treatment works

• DO NOT place into sharps or other waste container “as is”

© 2015 WM National Services, Inc.

40

Operationalizing the EPA Compliance Challenges – Federal Regulations

(c) WM National Services, Inc.

41

Defining “Hazardous” Within the Organization

• EPA Hazardous Waste: meets one of the definitions of

hazardous waste federally or at the state level; must

be a waste

• OSHA Hazardous Drug: a risk to employees due to

occupational exposure; may be a product or a waste

• DOT Hazardous Material: a risk to health and safety

while in transit; may be a product or a waste

• Biohazardous: meets the definition of an infectious risk

at the state level; may be a product or a waste

• Regulated medical waste

© 2015 WM National Services, Inc.

42

Identifying Hazardous Pharmaceutical Waste Under RCRA • P-listed pharmaceuticals (acutely hazardous)

• Sole active ingredient; unused; empty containers

• LD50 (oral) 50mg/kg

• Examples: nicotine, warfarin

• U-listed pharmaceuticals (toxic)

• Sole active ingredient; unused

• Examples: cyclophosphamide, mitomycin, lindane, selenium sulfide

• Pharmaceuticals that exhibit a characteristic of hazardous waste (D codes)

• Ignitability D001

• Toxicity D004 – D043

• Corrosivity D002

• Reactivity D003 © 2015 WM National Services, Inc.

43

Examples of P-Listed Pharmaceutical Waste

Arsenic trioxide (chemo) P012

Epinephrine base* P042

Nicotine P075

Nitroglycerin** (weak) P081

Phentermine (CIV)*** P046

Physostigmine P204

Physostigmine Salicylate P188

Warfarin >0.3% P001

* Salts excluded federally as of Oct. 15th, 2007; most states have accepted this position

** Excluded from the P list federally and in most states

***Salts excluded federally, first communicated October, 2010. Most states have accepted this position

© 2015 WM National Services, Inc. 44

Examples of U-Listed Pharmaceutical Waste

• Chloral Hydrate(CIV) U034

• Chlorambucil U035

• Cyclophosphamide U058

• Daunomycin U059

• Lindane U129

• Melphalan U150

• Mitomycin C U010

• Streptozotocin U206

• Selenium Sulfide U205

© 2015 WM National Services, Inc.

*Italicized items are chemotherapy agents.

45

Characteristic of Toxicity

• 40 chemicals which must be below specific leaching

concentrations

• Fail the Toxicity Characteristic Leaching Procedure (TCLP)

• Must evaluate IVs, such as total parenteral nutrition (TPN)

• May come out of regulation due to dilution (chromium,

selenium)

• Examples of potentially toxic pharmaceutical ingredients:

• Chromium D007

• m-Cresol D024

• Mercury (Thimerosal) D009

• Selenium D010

• Silver D011

© 2015 WM National Services, Inc. 46

Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity

• Multi-dose Flu Vaccine with thimerosal

Fluzone® Trivalent Multi-dose vial

• Human Insulin with m-cresol

Humalog®, Novolin®

• Selenium and Chromium injectables

• Multi-vitamin/mineral preparation

Centrum Silver® (OTC)

• Silver Sulfadiazine Cream

SSD ® Cream

©2015 WM National Services, Inc.

47

Characteristic of Ignitability

• Aqueous solution containing 24% alcohol or more by

volume and flash point < 140°F

• Non-aqueous solutions with flash points < 140°F

• Oxidizers

• Flammable aerosols e.g. Proventil® Inhaler

• Hazardous waste code D001

• Rubbing alcohol

• Topical preparations: Clindamycin®

• Some injections: Paclitaxel

©2015 WM National Services, Inc. 48

Definition of Empty

• To be “RCRA empty”, P-listed containers must be

triple rinsed & rinsate discarded as hazardous

waste; only used syringes excluded – EPA regulation

(in practice, no triple rinsing)

• The EPA requires P-listed wrappers & packaging to

be managed as RCRA hazardous waste because of

the residue remaining in them

• U-listed and D codes: empty if all contents

removed that can be removed by normal means

and no more than 3%, by weight, remaining

• Aerosols – never considered “empty”

©2015 WM National Services, Inc. 49

Pharmaceutical Waste Management Programs: Insuring Compliance

• Identifying relevant stakeholders

• COO, CNO (Chief Nursing Officer or comparable)

• Risk Management/Legal

• Director of Pharmacy

• Nurse Educators

• Infection Control Officer

• Environmental Health & Safety Officer

• Environmental Services Manager

• Obtaining “buy-in” from the C Suite down

• Appointing a Champion

• Developing a Core Team with a mandate

©2015 WM National Services, Inc. 50

Determining Which Drugs Become a Hazardous Waste

• Utilize the services of a specialized consulting firm

• Initial Inventory Analysis followed by method for

maintaining the waste categorization for new drugs

entering the system

51

Small Percentage of Pharmacy Inventories Designate as Hazardous Waste Federally

©2015 WM National Services, Inc. 52

Label the Shelves in Pharmacy

Identify

Hazardous

Waste

Choose

Container Sizes

and Locations

Pharmacy Implementation

Launch

Disposal in

Pharmacy

Label

Pharmacy

Shelves

©2015 WM National Services, Inc. 53

Role of Nursing in the Disposal of Pharmaceuticals

• Define prompts that will help nursing readily

recognize hazardous pharmaceutical waste.

• Messages on automated dispensing cabinets

dispensing screens

• Labeling bins / containers

• Messages on the electronic medication

administration records (eMARS) and Bar Code

Medication

Administration (BCMA) dispensing screens

• Messages on medication labels

• Select size, type, and location of containers

that will be used to dispose of pharmaceutical

waste ©2015 WM National Services, Inc. 54

Commonly Used Color Codes

Hazardous Pharmaceutical Waste

Trace Chemotherapy Waste Regulated Medical Waste

Non-Hazardous Pharmaceutical

Waste

©2015 WM National Services, Inc. 55

Summary of Pharmaceutical Waste Streams: Acute Care Hospital

Aerosols

Municipal

Solid

Waste

• Most packaging

• Most empty

bottles and vials

• Most empty IVs

• Paper

• Plastic

• No drugs

• No P-waste

containers

© 2015 WM National Services, Inc.

Sewer

System

Compatible Hazardous

Waste*

Trace

Chemo

(Sharps)

Trace

Chemo

(Soft)

Non -

Hazardous

Drugs

Red

Sharps

• P-listed

(inc. containers)

• U-listed

• D-listed t toxic,

• Ignitable

• Bulk chemo

• Haz/Chemo spill

clean up

Lined Non-Hazardous Waste Landfill

Medical Waste Incinerator

Municipal

Incinerator

Permitted for

Special Waste

(inc. drugs)

Autoclave/

Microwave

Shredded (Most states) Ash Ash

Lined Hazardous Waste Landfill

Federally Permitted Hazardous Waste Incinerator

• Ignitable

aerosols

• Pressurized

aerosols

Ash

• IVs

o Dextrose

o Saline

o Sterile Water

o Lactated

Ringer’s

o K salts

o Ca salts

o Mg salts

• Controlled

substances?

• No other drugs

• Empty vials and

ampules

• Empty syringes

and needles

• Empty IVs

• Gowns

• Gloves

• Tubing

• Wipes

• Packaging

• All non-hazardous

pharmaceutical

waste

• No biohazardous

drugs

• No sharps

• Empty syringes,

needles, ampules

(except chemo)

• Bio-hazardous

drugs

* Dual waste for sharps

Publicly

Owned

Treatment

Works

( POTW)

Water

Supply

Next Steps

• Determination of Generator Status

• Recordkeeping and reporting requirements

• Training and emergency response requirements

• Planning for RCRA inspections/enforcement

actions

• Lessons learned and best practices observed

©2015 WM National Services, Inc. 57

Next Steps for Program Management, Planning for Inspections and Best

Practices

July 30, 2015

Darrell J. Oman; Program Manager – Consulting Services

Stericycle Environmental Solutions

Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies,

and Other Healthcare Facilities

Next Steps to Program Compliance

1. Identify and Evaluate All Waste Streams and determination of generator status

2. Collect and Store Hazardous Waste Properly

3. Train Employees

4. Prepare and Save Documentation

5. Know Emergency and Spill Response Procedures

IMPORTANT REMINDER

Your generator “status” determines compliance requirements •Large Quantity Generator (LQG) •Small Quantity Generator (SQG)

•Conditionally Exempt Small Quantity Generator (CESQG)

59

Next Steps

Once you’ve identified all waste streams and made determinations on which are hazardous waste streams then generator status is determined. Next file (with the state usually) a Notification of Regulated Waste Activity form and receive a site specific USEPA generator I.D. #.

NOTE: generator status may change at any time due to: New waste stream(s) identified and generated

Changes in monthly generation rate of wastes

Therefore compliance requirements may change accordingly and immediately

60

RCRA Generator Status

Under the Federal rules there are three classes of generators (NOTE: State/Local regulations may be more stringent). 1. Conditionally Exempt Small Quantity Generator (CESQG)

Generate no more than 100 kg of hazardous waste, 1 kg of acutely hazardous waste, or 100 kg of contaminated waste from an acutely hazardous waste spill in a month. Accumulate no more than 1,000 kg of hazardous waste at any time.

2. Small Quantity Generator (SQG) Generate between 100 and 1,000 kg of hazardous waste and no more than 1 kg of acutely hazardous waste in one month. Accumulate no more than 6,000 kg of hazardous waste for up to 180 days (270 days if waste is to be transported over 200 miles).

3. Large Quantity Generator (LQG) Generate greater than 1,000 kg of hazardous waste or greater than 1 kg of acutely hazardous waste in one month. Accumulate greater than 6,000 kg of hazardous waste for up to 90 days.

61

Next Steps

Collect and Store Waste Properly Satellite Accumulation Areas (know rules)

Hazardous Waste Storage Area (know rules)

Train Employees According to Job Responsibilities

Within 6 Months of Hire or Job Change

Annual Training Required for Some Generators (LQGs)

Prepare and Save Documentation Inspections and Training Records

Uniform Hazardous Waste Manifests

62

Hazardous Waste Containers Hazardous Waste Containers can be placed

throughout a facility.

Hazardous Waste Containers must be:

under the control of the staff,

near the point of waste generation AND

closed unless being used.

Containers in the Satellite Accumulation Areas (SAA) must be moved to the Hazardous Waste Storage Area within 3 days of becoming full.

SAA Volume limits for P-List (1 quart ) and regular hazardous waste (55 gallons)

Containers are then considered a Hazardous Waste Storage Container and must be shipped off-site within 90 days if a LQG and 180 days if a SQG.

Waste Collection and Storage

63

Employee Training

Personnel must be trained

Employees whose responsibilities include hazardous waste management, storage, transport or recordkeeping must be trained within 6 months of starting or a job change

The type and degree of training required depends on each employee’s responsibilities associated with his/her job function

Generator status establishes training requirements:

LQGs – most stringent – annual training

SQGs and CESQGs – less stringent

64

Hazardous Waste Storage Area

Must be inspected weekly (inspection records maintained)

Meet all storage area requirements as described in 40 CFR 262.34 and 265.32 & 174 including but not limited to: Adequate aisle space

Impermeable floor surface

Secondary containment

Prepare Uniform Hazardous Waste Manifest (EPA Form 8700-22) for each hazardous waste shipment

Inspections and Reporting

65

Permitted Hazardous Waste vendors pick-up your wastes and provide a shipping manifest The UHWM is multi-copy shipping paper

required for shipments of hazardous waste

Why is Manifesting Important? A record to ensure that waste is managed

properly - “Cradle to Grave” record The generator (each location) is ultimately

responsible for the information contained on the manifest

Land Disposal Restriction Notification Form (LDR) also required

Uniform Hazardous Waste Manifest (UHWM)

66

Next Step

Know Emergency and Spill Response Procedures LQGs need a Haz Waste Contingency Plan

SQGs need elements of a Plan

Hazardous Waste Contingency Plan - a written document describing: Emergency response procedures including the following:

Emergency coordinator(s)

Emergency telephone numbers

Hazardous wastes generated

Arrangements with local emergency response services

Measures to prevent the release of hazardous waste

Emergency equipment

Evacuation plan

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Hazardous Waste - Inspections, Best Practices and Lessons Learned

Inspections and Enforcement USEPA/State Inspections

Recent cases

How to handle an inspection

Examples of common violations

Hazardous Waste Program Management – Best Practices and Lessons Learned Program management champion

Executive leadership and risk management perspective

Departments and department leadership perspective

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Federal/State Hazardous Waste Program Inspections

Can be brief or comprehensive and unannounced USEPA (Federal) inspections can

take 2-3 days

Can focus on certain hazardous waste streams or be building-wide or campus-wide inspections

No facility employees or leadership are exempt from being questioned or interviewed

Examples of typical areas of inspection: Waste determinations documentation

Recordkeeping/training/emergency response

Storage areas and containers

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RCRA Inspection Recommendations

When an inspector or inspection team arrives: Understand that the inspection is an opportunity to learn

and to find areas of program improvement

Gather and make available the best team of management and subject matter expertise to accompany the inspector(s)

Answer questions to the best of your knowledge - if an answer is not known then say so

Expect a closing summary meeting where preliminary findings (including alleged violations) are identified and discussed

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Inspection and Enforcement Efforts – Examples of Violations

Hazardous wastes are not identified

Open, unlabeled or mislabeled storage containers

Storage area is not adequate

Satellite accumulation issues

Training records/Manifest records

Exceeding storage time limit

Storage area inspection records

Outdated Contingency Plan

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Lessons Learned – Program Management

Facility/Corporate Executive Team and Risk Management Perspective Regulatory compliance with RCRA is not generally on the

radar screen unless there has been an incident or inspection

In Healthcare the TJC (The Joint Commission) has trained over 500 accreditation surveyors on the proper management of hazardous and pharmaceutical wastes

Operations structure, outsourcing and staff turnover can have a large impact on the compliance performance of the hazardous and Rx waste management program at any facility

Many hospitals, hospital systems, retail pharmacies and retailers don’t have RCRA environmental compliance expertise onsite or in-house.

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Lessons Learned – Program Management (cont.)

Store Operations, Facilities, Safety, Laboratory, Pharmacy, Clinical and Housekeeping Management and Staff Perspective

Hazardous waste management impacts nearly every department and professional discipline in a Healthcare facility and nearly all Retail operations (stores, distribution centers, etc.)

Generally the more centralized the management of the hazardous waste program is the more compliant the program

Recommend naming a Program Champion for the entire facility or company

Recommend centralizing all waste determinations documentation, inspection reports, waste generation reports and training documentation with the Program Champion

Recommend local onsite Program Coordinator and local access to required program documentation

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Gregory W. Blount

Troutman Sanders LLP

404-885-3291

[email protected]

Charlotte A. Smith, R. Ph., M.S.

Senior Regulatory Advisor

PharmEcology Services

WM Sustainability Services

713-725-6363

[email protected]

Darrell J. Oman

Program Manager – Consulting Services

Compliance & Regulatory Affairs

Stericycle Environmental Solutions

612-360-1213

[email protected]

Questions?

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15 Most Common Hazardous Waste Violations and Problems Found at Hospitals

Improper or lack of hazardous waste (HW) labeling (go to HW labeling).

No or infrequent weekly inspections of HW storage/satellite areas (go to for inspections

requirements).

Open containers of HW (go to container sealing requirement).

Improper disposal of chemotherapy drugs (go to hazardous waste determinations and see

information for U-list waste).

Failure to perform or improper hazardous waste determinations (go to hazardous waste

determinations).

No or inadequate HW manifests (go to hazardous waste manifest).

Throwing HW down the drain.

Improper management of mercury-containing wastes, including but not limited to, fluorescent light

bulbs, mercury vapor lights, thermometers, sphygmomanometer, gastric tubes, thermostats, etc.

(go to mercury in healthcare facilities)

Improper management of expired pharmaceuticals, paints, etc. (go to pharmaceuticals in

healthcare facilities)

Lack of a contingency plan (go to emergency planning).

Lack of or inadequate training of employees in HW management (go to personnel training).

Failure to ensure that HW meets Land Disposal Restrictions (go to shipping wastes off-site).

Failure to upgrade/close underground storage tanks (USTs) by 12/22/98 (go to UST inspection

protocol).

Malfunctioning leak detection systems.

Improper consolidation of wastes from nearby facilities.

Source: EPA Region 2.

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References and Resources

Healthcare Sector Environmental Laws and Regulations

http://www.epa.gov/lawsregs/sectors/healthcare.html

RCRA/Hazardous Waste Resource Locator

http://www.envcap.org/statetools/hzrl/index.cfm

Profile of the Healthcare Industry – USEPA Document

http://www.epa.gov/compliance/resources/publications/assistance/sectors/n

otebooks/health.pdf

Managing Pharmaceutical Waste – A Discussion Guide for Health-

System Pharmacists

http://www.ashpadvantage.com/docs/PharmaWaste-Discussion-Guide.pdf

Table of Common Wastes in Health Care (Wisconsin version)

http://dnr.wi.gov/files/PDF/pubs/wa/wa1259.pdf

Self-audit Checklists for LQGs and SQGs (Wisconsin examples)

http://dnr.wi.gov/files/PDF/pubs/wa/wa1263.pdf

http://dnr.wi.gov/files/PDF/pubs/wa/wa1264.pdf

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Resources

Environmental Leader • www.environmentalleader.com

Environmental Law & Policy Monitor www.environmentallawandpolicy.com

EPA Management of Hazardous Waste Pharmaceuticals

http://www2.epa.gov/hwgenerators/management-pharmaceutical-hazardous-waste

Hazardous Waste Pharmaceuticals Wiki http://hwpharms.wikispaces.com/

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Retail Inspection Tracker

Created through Troutman Sanders subsidiary, eMerge

Secure, easy to use inspection tracking application

Track each inspection finding in detail

Beneficial tracking options including: Calendar of upcoming corrective action and response due dates

State-by-state inspection trends

Analysis of common findings to assist with program improvement

Monthly/yearly comparison of inspection activity

Comparison of inspections with and without findings

Customizable for each retailer’s specific issues and preferences

Receive automatic, customized alerts for desired metrics E.g., hot states, high-priority inspection findings

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