1. 1 Healthcare Environmental Compliance Pitfalls December 6, 2007

2. 2 Healthcare Compliance?  In the business to promote health  Hospitals already fall under several regulatory standards  Environmental compliance refers to:  Hazardous waste or RCRA  Air quality or air permits requirements  Waste water discharges

3. 3 Healthcare compliance  Regional assistance programs try to educate and help facilities identify compliance gaps and pollution prevention opportunities.  East coast EPA compliance initiative in 2006  Compliance pitfalls identified on east coast, probably mirror the compliance gaps we have in Midwest

4. 4 Healthcare compliance  Our region, Region 7, has begun inspecting hospitals  State tables in vendor area  2006 Region 2 (east coast) audit finding

5. Adapted from Region 2 August 2006 5 Results EPA Region II: Compliance Monitoring & Incentives Programs Hospitals Universe 480 Inspections 49 Enforcement Actions 36 Formal Enforcement Actions 11 ($1,523,613) Settlements 9 ($642,612) Audit Agreements 41 Voluntary Disclosures 156 covering 581 facilities ($29,947,688 for 143 resolved) Violations Corrected 3223

6. Adapted from Region 2 August 2006 presentation 6 Healthcare Violations – All R2

7. Adapted from Region 2 August 2006 presentation 7 Healthcare CAA Violations – All R2

8. 8 Air Compliance Issues  Failure to use properly trained and accredited asbestos personnel.  Failure to notify EPA of asbestos removal projects and keep required documentation/recordkeeping.  Failure to properly dispose of asbestos debris.  Failure to close lids on parts washers when not in use.  Failure to properly handle CFCs and records.  Failure to include ETO sterilizer, spray paint booth, and parts degreaser in air permit.

9. Adapted from Region 2 August 2006 presentation 9 Healthcare CWA Violations – All R2

10. 10 Water Compliance Issues  No permit for wastewater discharges  Not complying with permit conditions  No/inadequate secondary containment of storage tanks/containers  No SPCC plan  Floor drains

11. Adapted from Region 2 August 2006 presentation 11 Healthcare RCRA Violations – All R2

12. What to Expect When EPA Shows UP Routine RCRA Inspections, Common Violations, and Enforcement Follow-up Dedriel Newsome - RCRA Inspector Environmental Field Compliance Branch, USEPA WK # (913) 551-7049 or (e-mail) – Newsome.Dedriel@EPA.gov

13. 13 Goals of Enforcement  Environmental Protection  Correction of Violations - Return to compliance  Deterrence  Fairness - level playing field

14. 14 Purpose of RCRA Inspection  Determine generator status  Determine if the facility is in compliance with the applicable RCRA regulations based on their generator status

15. RCRA Inspection  Conduct desktop file review  Conduct drive-by surveillance of facility  Initial facility entry  Conduct initial interview (general facility information)

16. RCRA Inspection  Collect facility process information  Collect facility waste stream information  Conduct visual inspection – hazardous waste storage areas and satellite accumulation areas  Conduct records review  Conduct exit briefing

17. 17 Typical Hospital Wastes / Areas Visually Inspected  Clinical Labs (spent solvents - distillation)  Research Labs (spent solvents, corrosives, off-spec chemicals, unwanted chemicals)  Facilities - Maintenance, Painting, Grounds, etc. (spent solvents, waste paints, used oil, parts washer solvents, rags, waste pesticides, batteries, mercury wastes, fluorescent lamps, aerosols)  Pharmacies (off-spec drugs, investigatives)  Operating Room (breathing machine spent media)

18. 18 Typical Hospital Wastes / Areas Visually Inspected  Housekeeping (Autoclave indicator tape)  Printing (spent solvents, waste inks)  Biomedical (batteries, soldering wastes)  IT (batteries, soldering wastes, solvent rags)  Radiology (lead aprons, film developing wastes)  Chemical Storage Areas (Off-spec and unwanted chemicals)

19. 19 Common Violations Hazardous Waste Determinations  What we find…  Mischaracterized or uncharacterized wastes; or  Materials that are unused and pending disposal not characterized  Changes in processes!!!

20. 20 Common Violations Satellite Accumulation Container Management  What we find…  Unlabeled satellite containers (In MO, also undated satellite containers and >1yr in area; in KS not having the words “Hazardous Waste”)  Open satellite containers  Containers not at or near the point of generation and under the control of the operator  Containers not moved in 3 days of filling (In KS and MO, one container per waste stream)

21. 21 Common Violations Storage Container Management  What we find…  Unmarked/unlabeled storage containers  Undated storage containers  Open storage containers  Incompatibles stored without proper separation

22. 22 Common Violations Illegal Treatment, Storage, and Disposal Offering Hazardous Waste Without a Permit  What we find…  Evaporation of hazardous wastes  Disposal of hazardous waste with non-hazardous waste (i.e. general trash or biomedical waste)

23. Following the RCRA Inspection  Following RCRA Inspection, what should the facility do?  Achieve compliance with RCRA ASAP!!!!!!!  Provide a response to EPA for the Notice of Violation (NOV) n Response is required even if compliance not achieved! n Follow-up response should be provided when compliance is achieved

24. Following the RCRA Inspection (cont.)  EPA RCRA Inspection Report  Provided to a compliance officer for review to determine enforcement response  Typically provided to the facility after it is completed

25. 25 Estimated Hospital RCRA Inspections and Completed Enforcement Actions in the Past 5 Years  EPA conducted about 30 inspections  States conducted about 26 inspections  EPA Informal Orders – 28 completed  EPA Formal Orders – 4 completed  State Informal Orders – 11 completed  State Formal Orders – 1 completed (These numbers do not include pending orders)

26. 26 Informal Enforcement  Notice of Violation (NOV)  Issued by inspector following inspection or  Sent via letter  Letter of Warning  Sent via letter and/or  May include information request (Section 3007)

27. 27 Formal Civil Enforcement  RCRA Section 3008(a) Order  Includes penalty  May include compliance measures  May include sampling  RCRA Section 3008(h)  RCRA Corrective Action Order  Usually includes sampling and monitoring  Does not include penalty  RCRA Section 3013 Order  Hazardous waste may present a “substantial” hazard to human health or the environment  Includes monitoring, analysis, and testing  Does not include penalty

28. 28 Formal Civil Enforcement (cont.)  RCRA Section 7003 Order  Solid waste and/or hazardous waste may present a “imminent and substantial” hazard to human health or the environment  Usually “fast track” response  Does not include penalty  Referral to Department of Justice (DOJ)  Referred if negotiations have stalled  Referred if facility not complying with Order  May be referred if multiple facilities are included in the enforcement proceedings

29. 29 Criminal Enforcement  Inspection information may be turned over to criminal investigation team if violations appear to be “intentional”  Criminal and Civil Enforcement may proceed at the same time  Violator may go to prison

30. COMPLIANCE ASSISTANCE STATE WEB PAGES  Kansas Department of Health and Environment (KDHE)  http://www.kdhe.state.ks.us/environment/index.html http://www.kdhe.state.ks.us/environment/index.html  Missouri Department of Natural Resources (MDNR)  http://www.dnr.mo.gov/  Nebraska Department of Environmental Quality (NDEQ)  http://www.deq.state.ne.us  Iowa Department of Natural Resources (IDNR)  http://www.iowadnr.com/ http://www.iowadnr.com/

31. COMPLIANCE ASSISTANCE EPA WEB PAGES  EPA HQ Web Page www.epa.gov  EPA Region 7 Web Page www.epa.gov/region07/  EPA Region 7 RCRA Web Page www.epa.gov/region7/waste/index.htm

32. 32 What Can My Facility Do Prior to the RCRA Inspection?

33. 33 What Can My Facility Do Prior to the RCRA Inspection?  Obtain the federal and state regulations and become familiar with them  Keep your facility in compliance – Characterize all waste streams!!!!  Schedule and maintain employee training  Contact EPA or State with questions  Access and use various “tools” from State and EPA websites

34. 34 What Can My Facility Do Prior to the RCRA Inspection?  Conduct a self-audit and disclose the violations found to the EPA  EPA’s Self-Audit Policy (a.k.a. Self- Disclosure)  See: http://www.epa.gov/compliance/incentive s/auditing/auditpolicy.html  Contact Becky Dolph, EPA R7 CNSL at 913- 551-7281 or at dolph.becky@epa.gov

35. 35 Questions