1. MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano & Mario Perez 2015 TCEQ Environmental Trade Fair

2. Who Regulates Medical Waste in Texas “Medical Waste” Definitions Types of Authorizations Application Contents/Processing Ebola Experience 2014 AGENDA

3. REGULATORY AGENCIES TCEQ Other local or Federal agencies (e.g. CDC and OSHA) Texas Department of State Health Services (DSHS) U.S. Department of Transportation (DOT) Medical Waste Collection Transportation Treatment Storage Disposal Air Permits Provides approved treatment & disposition methods Review & approval of new treatment technologies Shipping Labeling Packaging Special Permits

4. 25 TAC §1.132 (44) - Special waste from health care-related facilities –Animal waste exposed to pathogens –Bulk human blood & body fluids –Pathological waste –Microbiological waste –Sharps DEFINITION - DSHS

5. 49 C.F.R., Parts 171-180 - DOT Hazardous Materials Regulations Category A Infectious Substance: Capable of causing: –permanent disability –life-threatening disease –fatal disease Category B Infectious Substance DEFINITION - U.S. DOT

6. –30 TAC §330.3(85) - Treated and untreated special waste from health care-related facilities as used by: DSHS, and; “Regulated Medical Waste” defined in 49 CFR §173.134(a)(5) - a waste or reusable material known or suspected of containing a Category B infectious substance that is derived from medical treatment or biomedical research. DEFINITION - TCEQ

7. Exceptions

8. TCEQ Authorizations Notification Registration by Rule MSW Type V Registration Self-transporters On-site treatment Transporter Mobile On-site treatment Transfer Stations Treatment & Storage (Autoclave, chemical treatment, incineration) Self Transporters: Generate > 50 pounds per month of untreated medical waste Transport their own waste to an authorized medical waste processing facility Form TCEQ-20287 (07/2006) On-site Treatment: Generator required to notify the TCEQ for the operation of an approved treatment process unit used only for treatment of on-site generated medical waste. Acknowledgement Letter from MSW Permits

9. TCEQ Authorizations Registration by Rule Transporter Mobile On-site treatment Transporter : for persons that plan to transport untreated medical waste and that are not the generator of the waste Form TCEQ-00426 (07/2006) Mobile On-site Treatment : for persons that plan to treat untreated medical waste on-site and that are not the generator of the waste Form TCEQ-00427 (07/2006)

10. TCEQ Authorizations MSW Type V Registration Transfer Stations Treatment & Storage (Autoclave, chemical treatment, incineration) Type V Registrations: 30 TAC §330.9(n) - for a facility that stores, transfers or process (i.e. stores, treats and transfers) untreated medical waste that is received from off-site sources

11. Applicable Rules in 30 Texas Administrative Code (30 TAC):  Chapter 330  Chapter 330 – Subchapter Y only for medical waste  Chapter 116  Chapter 305  Chapter 39  Chapter 37 MEDICAL WASTE - TYPE V REGISTRATION

12.  General Information  Core Data Form (Form No. 10400)  Part I  Part I Form (Form No. 0650)  Part II  Waste Acceptance Plan  Facility Impact  Coordination Letters APPLICATION CONTENT

13.  Part III – Site Development Plan  Facility Design  Processing Unit Designs  Closure Plan & Cost Estimates  Part IV – Site Operating Plan (SOP)  Sub Ch. E (Transfer & Processing Units)  Sub Ch. Y (Med Waste Management)  Storage Requirements - 330.1209  Treatment & Disposition - 330.1219 APP. CONTENT - CONT'D

14. TYPE V REG. APPLICATION PROCESS Application Determined Preliminarily Complete Initial Technical Review 45 Day NAORPM Mailed/Published Comment/Meeting Request Period (60 Days) 45 Day NAORPM Mailed/Published Comment/Meeting Request Period (60 Days) NOD Process Public Meeting if Requested Declaration of Technical Completeness Final Action Declaration of Technical Completeness Final Action

15. Ebola in the U.S. Task Force on Infectious Disease Preparedness and Response TCEQ’s role Conclusion - Task Force Report & Recommendations EBOLA EXPERIENCE 2014

16. First Case on Sept. 30, 2014 at a Texas hospital Task Force on Infectious Disease Preparedness and Response Creation & Duties The second and third cases within 2 weeks Total of 337 people were monitored throughout the crisis EBOLA IN THE U.S.

17. The Task Force Created Oct 6 – 17 members Immediately provide frontline support for decision makers Identify issues/provide resolutions Public transparency Waste management - TCEQ TASK FORCE

18. Classification of Ebola contaminated material List of treatment & disposal facilities Treatment options & how effective Packaging/Labeling requirements SAMPLE QUESTIONS FOR TCEQ

19. TCEQ’S RESPONSE Classification of Ebola: hospital generated – Cat A; private residences: special waste and managed as Cat A Identify Med Waste Facilities: types of equipment and capacities for each treatment unit at each facility

20. TCEQ’S RESPONSE Efficacy for each type of treatment – incineration preferred Disposal options – ash Packaging & Labeling – DOT Cat A Example - Triple Packaging

21. December 1, 2014 Issue 14 – Decontamination & Waste Removal Direct the appropriate state agencies to: –work with hospitals/medical professionals: how can waste be properly and safely treated on-site; –evaluate all portable treatment options; –evaluate and identify all decontamination and waste handling procedures; and –assure availability of regional supplies to handle Category A waste Develop a public health emergency action plan 84 th Legislature – Proposed HB 2950 & SB 538 TASK FORCE RECOMMENDATIONS CONCLUSION

22. Mario Perez Mario.Perez@tceq.texas.gov or (512) 239-6681 Daniela Ortiz de Montellano Daniela.Ortiz-Demontellano@tceq.texas.gov or (512) 239-2210 CONTACTS :

23. http://www.tceq.texas.gov/permitting/waste_permits/msw_ permits/mw_disposal.html - checklists & other infohttp://www.tceq.texas.gov/permitting/waste_permits/msw_ permits/mw_disposal.html https://www.tceq.texas.gov/publications/rg/rg-001.html - Texas regulatory guidance document on medical wastehttps://www.tceq.texas.gov/publications/rg/rg-001.html REFERENCES