Is Your Hospital Campus Complying with RCRA Hazardous Waste Regulations?

Darrell J. Oman

Meet our Presenter

2

• Darrell has more than 30 years of consulting and risk management experience in the Environmental, Health and Safety (EH&S) field and obtained his B.S. of Mining Engineering from Michigan Technological University. While in leadership and management positions with several national environmental engineering consulting firms, he provided consulting expertise in the areas of environmental risk management, permitting, compliance auditing and training, EH&S program development and environmental due diligence assessments on property transactions and business mergers and acquisitions.

• He has presented at numerous national and regional professional and industry sector conferences, including for the American Health Lawyers Association (AHLA) and the American Society for Healthcare Engineering (ASHE). He has also been a guest instructor and lecturer for the graduate and post-graduate business schools at the University of Minnesota and the University of St. Thomas and is a member of American Society for Healthcare Engineering (ASHE) and Association for the Health Care Environment (AHE).

• Darrell is a nationally recognized environmental compliance and risk management consulting professional in the healthcare and hospital industry sector providing a wide range of consulting services including regulatory compliance auditing; agency inspection notice-of-violation (NOV) corrective response strategy guidance and action plan development; development and implementation of hospital or hospital system organizational and practice changes and developing, implementing and conducting environmental compliance and regulatory training to environmental services, pharmacy, risk management, compliance, patient care, laboratory, facility management/plant operations leaders and to hospital and hospital system executive management teams.

Topics Covered

Brief Hazardous Waste (RCRA) HistoryApplicability of RCRA to HospitalsRecent RCRA Regulations Changes

Campus Program ManagementQuestions?

3

Who’s that? What’s that? • Agency Acronym Overload Plus Myriad Uses and

Meanings of the Word “Hazardous” • OSHA: Hazard Communication Standard (Employee

Right-to-Know) – “Hazardous Substances” and “HazardousChemicals”

• USDOT and The Joint Commission - “Hazardous Materials”• USP 797 and 800 - NIOSH “Hazardous Drugs”• Regulated Medical Waste (RMW): “Biohazardous Waste”

and “Infectious Waste”• USEPA - “Hazardous Waste” and also now as of 2019

“Hazardous Waste Pharmaceuticals”

4

History

Solid Waste Act of 1965

Resource Conservation and Recovery Act (RCRA) of 1976

Amendments of 1984 and 1986

Hazardous Waste Generator Improvements Rule of 2017

Management Standards for Hazardous Waste Pharmaceuticals - Subpart P of 2019 (February)

5

Hospitals are Complicated Waste Generators

Users of thousands of “hazardous substances” and “hazardous chemicals” = thousands of unique wastes and waste streams. Note: a 300 staffed bed hospital likely has a minimum of :

500-1,000 hazardous chemicals used in the Clinical/Pathology Laboratories2,000-4,000 Pharmaceuticals on hand including 100s of Chemotherapy agents and/or “hazardous drugs (HDs)”200-500 hazardous chemicals in use by Facilities, Imaging, Sterile Processing and EVS/Housekeeping. Also, every hospital generates “Universal Wastes” which are a subset of RCRA hazardous wastes

6

What is a RCRA Generator?

The hospital facility (a specific physical property) is the Generator of hazardous waste The Generator must identify and properly

manage all hazardous waste generated to: Protect human health and the environment Reduce or eliminate (waste minimization

requirements) the amount of waste generated including hazardous waste

Conserve energy and natural resources through waste recycling and recovery

IMPORTANT COMPLIANCE POINT: It is a Generator’s responsibility SOLELY to fully and accurately identify and evaluate their wastes. Also, if the hospital generates a “new” waste or waste stream it is their responsibility to evaluate this new waste or waste stream.

7

Recent RCRA Hazardous Waste Regulations Changes and State/Local Regulations

Hazardous Waste Generator Improvements Rule of 2017 Management Standards for Hazardous Waste Pharmaceuticals -

Subpart P of 2019 (February) Relationship to Federal Agency (USEPA)

Regulatory authority may be delegated to State which in turn may delegate to a Local authority (Alaska and Iowa don’t have RCRA compliance authority)

State & Local Agencies (County or Municipal) Must be as stringent but may be more stringent than Federal

regulations – Many are more stringent Examples: TN, NJ, CA, WA, MN, WI, KY, Hennepin County

Regulatory inspections more likely from State or Local authorities.

8

Summary Review: Hazardous Waste Generator Improvements Rule

Published and in effect Federally on May 30, 2017:Reorganizes rules to simplify and clarifyClose gaps to strengthen environmental protectionProvide greater flexibility in management of hazardous wastesSome key changes include:

Allowing VSQGs to ship hazardous waste to a LQG of the same controlling entityAddressing episodic generation which currently triggers more stringent regulationsLabeling of waste containers to better align with DOT and OSHA regulationsRequiring SQG re-notifications and Contingency Plan “executive summary” for LQGs

9

GIR Current Status by State

10

https://www.epa.gov/hwgenerators/where-hazardous-waste-generator-improvements-rule-effect#tx

Summary Review: Hazardous Waste Pharmaceutical Rule

Defines “Hazardous Waste Pharmaceuticals”Pertains only to the management of hazardous waste pharmaceuticals for Healthcare facilities (hospitals, pharmacies, dentists, nursing facilities, long term care facilities (LTCF) and clinics)These rules are mandatory – not an option to other USEPA regulationsEffective date of rule is August 21, 2019 for IA, AK, KY, NC, NJ, PA and Puerto Rico and in all other states in accordance with their particular rule adoption process (July 1, 2022 deadline for all)RCRA hazardous waste pharmaceuticals banned from discharging to sewers on August 21, 2019Hazardous waste pharmaceuticals would not count towards generator statusOTC nicotine replacement therapies exemption from P-Listing (however states may still choose to be more stringent)

11

Hazardous Waste Pharmaceutical

Rule Current Status by State

12

https://www.epa.gov/hwgenerators/where-are-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

Helpful Links

Frequent Questions About Implementing the Hazardous Waste Generator Improvements Final Rule and Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Final Rule https://www.epa.gov/hwgenerators/frequ

ent-questions-about-implementing-hazardous-waste-generator-improvements-final-rule https://www.epa.gov/hwgenerators/frequ

ent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and

13

Bottom-Line: Why is Compliance with RCRA Important?

Generator has “Cradle to Grave” (SUPERFUND) legal/financial liability for hazardous wastes. Fines, consent orders and stipulation agreements for compliance violations are possible.

Possible civil and criminal penalties for non-compliance Promotes environmental stewardship – meet pollution

prevention and waste minimization goals Comply with 3rd Party accreditation - The Joint Commission,

DNV, CMS, HFAP, CIHQ and Others

14

RCRA Unraveled – 5 Steps1. Identify and Evaluate All Waste Streams (Waste

Determination Process) - Focus for today is Step # 11. The full and accurate completion of this step is a prerequisite to

all other steps since Generator status (LQG vs. SQG vs. VSQG) is based on the types and monthly volumes of RCRA hazardous waste generated

2. Generator status also determines actual RCRA hazardous waste program compliance requirements

3. Finding: Step # 1 is rarely complete or up-to-date at hospitals and required documentation demonstrating the Generator’s waste determination for every waste or waste stream is often incomplete or missing

2. Collect and Store Hazardous Waste Properly*3. Train Employees*4. Prepare and Save Documentation*5. Know Emergency and Spill Response Procedures*

* To be covered in detail on future sessions

15

Hazardous Waste Determination Process

16

Example Waste Determination Using Generator Knowledge (Or Lack Of)

Serology (Study of Blood Serum) Department Analyzer Waste• Large hospital laboratory in a Midwest state• Lab had never had a RCRA compliance inspection for RCRA from

either the state or USEPA• No laboratory wastes or waste stream had ever been evaluated (i.e.

determined whether RCRA wastes or not) and no wastes or waste streams were being collected as RCRA

• Analyzer waste containers were emptied into the sinks when full• Information from the analyzer user manual and accompanying

product SDSs was reviewed – product was 60-80% Isopropanol.

17

Determine Your Campus Generator Status

Once ALL waste streams have been evaluated you must decide your generator status which will establish your facility’s RCRA program compliance requirementsLarge Quantity Generator (LQG)Small Quantity Generator (SQG)Very Small Quantity Generator (formerly known as CESQG)

Note: Check with your State and/or Local regulatory agencies as generator status definitions vary:https://www.envcap.org/srl/resourcelocator.php?id=7

18

Noncompliant RCRA Hazardous Waste Programs

Historically a general lack of regulatory inspections of and environmental compliance enforcement on the hospital industry

Some state and local regulatory agencies started inspecting in the mid ‘00s. Regulatory guidance and compliance support varies greatly from state to state. Multiple recent inspections in the with fines ranging up to $340,000.Recommendation: Consider completing your campus/facility “EPA Resume” which can help uncover obvious incorrect or outdated regulatory compliance information

19

Federal or State RCRA Hazardous Waste Program Inspections

Can be brief or comprehensive and unannouncedUSEPA (Federal) inspections can take 1-3 days

Can focus on specific hazardous waste streams or all wastes or waste streamsNo healthcare facility employees or departments are exempt from being questioned or interviewedExamples of typical areas of inspection:

Waste determinations documentationRecordkeeping/training/emergency responseStorage areas and containers

20

Inspection Findings and Enforcement – Examples of Violations

Hazardous wastes are not identified or evaluatedOpen, unlabeled or mislabeled storage containers Storage area is not adequateSatellite accumulation issuesTraining records/Manifest recordsExceeding storage time limitStorage area inspection recordsOutdated contingency planGood Resource: Healthcare Environmental Resource Center http://www.hercenter.org/hazmat/hazardouswaste.cfm

21

Hospital Campus Program Management Solutions

First: Executive Team and Risk Management Perspectives to Consider:Compliance with complex environmental regulations like RCRA is not generally on the radar unless there has been an incident (chemical or RCRA hazardous waste spill) or an unsatisfactory regulatory inspection (such as a RCRA Notice-of-Violation)Typical Joint Commission surveys address few EPA/RCRA regulatory compliance requirements or only superficiallyHospital departmental organizational structures and dynamics such as turnover or outsourcing can have a significant impact on performance of the RCRA hazardous waste and all waste management programs

22

Regulatory Risk Scale

Hospital Campus Program Management Solutions (cont.)

Lessons Learned from Facilities, Safety, Laboratory, EVS, Pharmacy and Clinical Management and Staff Engage all key compliance and departmental stakeholders Remember to complete Step # 1 = Program compliance will be near impossible without a full, accurate and verifiable hazardous waste inventory. Centralize management of the campus RCRA hazardous waste programCentralize and retain all waste determinations documentation, inspection reports, manifests, notifications and training documentationConduct mock inspection audits (self-audits or 3rd party compliance auditors) covering all departments of your campus

23

24

Include All Key Stakeholders

Waste Service Provider

Senior Leadership

Process Improvement Team

Full Participation Leads To Safe, Compliance & Sustainable Practices

Education

Pharmacy

Nursing / Patient Care

Infection Control/EVS

Materials Management

Program Champion

Facilities and Safety Hospital-wide Green

Team

Risk Management(Clinical and Enterprise) Quality Compliance

Slide from Ken Haber’s RCRA Compliance Session at ASHE 2019Ken is Director, Network Environmental Health and Safety

Hackensack Meridian Health

Session Review: Topics Covered

Brief Hazardous Waste (RCRA) HistoryApplicability of RCRA to HospitalsRecent RCRA Regulations Changes

Campus Program ManagementQuestions?

25

Questions?

26

Speaker Information

Darrell J. Oman Technical DirectorSenior Environmental Consultant

Contact• Email: doman@braunintertec.com• Phone: 612.360.1213

27

Next Month’s Webinar

28