1. Gulay Aki, P.E. Mario Perez Municipal Solid Waste Permits Section Texas Commission on Environmental Quality Trade Fair 2016 Medical Waste Management in Texas New Rules Medical Waste Management in Texas New Rules

2. Agenda  Why Rulemaking?  Rulemaking Timeline  Existing vs. Future  Overview of the Revisions  How to Comply?  Next Steps for the Agency

3. Why Rulemaking? House Bill (HB) 2244 Filed by Senator Zerwas - 84th Legislature Signed by the Governor -June 10, 2015 Section 5 - Adoption - No later than June 1, 2016, Rules adopted must minimize the effect on other rules regulating municipal solid waste (MSW) facilities.

4. Requires a new Chapter in 30 Texas Administrative Code (30 TAC) for Regulation of medical waste HB 2244

5. Scope of HB 2244- Cont. Site Operating Plan Site Development Plan Notice Procedures Permit & Registration Duration & Limits Procedural Requirements for Applications Waste Acceptance and Analysis Access Control Control of Litter & Windblown Material Operating Hours

6. HB 2244 – Specific Criteria for: Buffer distance of no greater 25 feet; Refrigerated transporter vehicle can be located within buffer zone; Treated medical waste sent to landfill must have a certification statement; Operating hour and buffer zone revisions should be non- notice modifications; and Implementation of the new rule for existing permits/registrations must be processed without notice

7. Rulemaking Timeline June 10 th HB 2244 signed by Governor August 18 th First Stakeholder Meeting Sep. 21 st Second Stakeholder Meeting Dec. 25 th Proposed Rule Published in TR Jan. 25 th Public Hearing Feb. 8 th Close of Public Comment Period Apr. 8 th TR sent rule package to OCC Apr. 27 th Agenda Adoption by Commission May 19 th Effective Date

8. Existing vs. Future Chapter 330 Primary Location: Subchapter Y- Medical Waste (MW) Management Subchapter A – General Information Subchapter B – Permit and Registration Application Procedures Subchapter E – Operational Standards Subchapter G – Surface Water Drainage Subchapter L – Closure, Post-Closure, and Corrective Action Cost Estimates Subchapter M – Location Restrictions Subchapter P – Fees and Reporting Chapter 326 Subchapter A – General Information Subchapter B – Packaging, Labeling and Shipping Requirements Subchapter C – Exempt Medical Waste Operations Subchapter D – Operations Requiring A Notification Subchapter E – Operations Requiring A Registration by Rule Subchapter F – Operations Requiring A Registration Subchapter G – Fees and Reporting

9. Existing vs. Future Chapter 330 Chapter 326 Subchapter A – General Information Subchapter B – Packaging, Labeling and Shipping Requirements Subchapter C – Exempt Medical Waste Operations Subchapter D – Operations Requiring A Notification Subchapter E – Operations Requiring A Registration by Rule Subchapter F – Operations Requiring A Registration Subchapter G – Fees and Reporting

10. Subchapter A 326.1 Purpose and Applicability 326.3 Definitions 326.5 General Prohibitions Subchapter B 326.17 Identification 326.19 Packaging 326.21 Labeling Containers Excluding Sharps 326.23 Shipping Subchapter C 326.31 Exempt Medical Waste Operations

11. Existing vs. Future Chapter 330 Chapter 326 Subchapter A – General Information Subchapter B – Packaging, Labeling and Shipping Requirements Subchapter C – Exempt Medical Waste Operations Subchapter D – Operations Requiring A Notification Subchapter E – Operations Requiring A Registration by Rule Subchapter F – Operations Requiring A Registration Subchapter G – Fees and Reporting

12. Subchapter D 326.37 General Requirements 326.39 On-Site Treatment by SQG(s) 326.41 On-Site Treatment by LQG(s) 326.43 Medical Waste Collections & Transfer by Licensed Hospitals Subchapter E 326.53 Transporters 326.55 Mobile Treatment Unit

13. Subchapter F 326.61 Applicability & General Information 326.63 Property Rights 326.65 Relationships with Other Governmental Entities 326.67 Relationship with County Licensing System 326.69 Registration Application Formatting, Posting, Appointment & Fees 326.71 Registration Application Contents 326.73 Registration Application Processing 326.75 Site Operating Plan 326.77 Duration, Limits and Additional Registration Conditions Subchapter G 326.85 Purpose and Applicability 326.87 Fees 326.89 Reports

14. Chapter 326 Authorizations Notification Registration by Rule Registration On-site treatment by SQGs & LQGs Medical Waste Collection &Transfer by Licensed Hospitals Transporters Mobile Treatment Units Transfer Stations Treatment & Storage (Autoclave, chemical treatment, incineration)

15. Overview of Revisions Applies to? What is the current rule? What will it be in Chapter 326? Why different?

16. New Definitions Incineration Manifest Revised Definitions Generator – Small and Large Quantity Putrescible Medical Waste Source Separated Recyclable Material Storage- Pre- Collection, Post-Collection Reworded for Medical Waste 8 Definitions out of 68 Definitions 326.1 Purpose and Applicability 326.3 Definitions 326.5 General Prohibitions 326.7 Other Authorizations Revisions- Subchapter A

17. Generator: SQG =< 50 lbs/month LQG > 50 lbs/month Storage: Pre-Collection – Generator Post-Collection – Transporter < less than 72 hrs. is temporary Post-Collection – Processor

18. During Pre-Collection – Optional Post-Collection for Transporter – 72 hours after initial pickup Post-Collection for Processor – 72 hours after receipt Refrigeration Requirement Clarification

19. Labeling & Manifest Ch. 330 Weight and contents of container on label Size – 0.5” Transporter must list the number of containers & send manifest listing weight of each container measured by a certified scale within 45 days. Fees are based on weight only Ch. 326 Weight or volume on label Size – 0.25” Number of containers not required to be listed & certified scale not required. Volume is the new option. Fees are based on weight or volume

20. Labeling & Manifest Ch. 330 Ch. 326

21. Rev(s). Cont. Subchapter D Subchapter D 326.37 General Requirements 326.39 On-Site Treatment by SQG(s) 326.41 On-Site Treatment by LQG(s) 326.43 Medical Waste Collections & Transfer by Licensed Hospitals

22. Licensed Hospitals Ch. 330 Ch. 326 330.9(e)- Registration required Submittal requirements are not listed. 326.43 - Notification required Submittal requirements are listed.

23. Subchapter E 326.53 Transporters 326.55 Mobile Treatment Unit

24. Transporters Financial Assurance is removed Annual registration fee based on weight or volume & paid within 30 days of invoice Annual report is due by March 1 st & fee will be invoiced thereafter Electronic manifest as an option when agency is ready Unit malfunction- RBR updated when new units in service>5 days RBRs expire annually on Sep. 30 th RBRs submittal renewal form by August 1st

25. Subchapter F 326.61 Applicability & General Information 326.63 Property Rights 326.65 Relationships with Other Governmental Entities 326.67 Relationship with County Licensing System 326.69 Registration Application Formatting, Posting, Appointment & Fees 326.71 Registration Application Contents 326.73 Registration Application Processing 326.75 Site Operating Plan 326.77 Duration, Limits and Additional Registration Conditions

26. Registration Applications Ch. 330 Ch. 326 No medical waste from public Four copies for initial submittal No electronic submittal Structured as Parts I through IV 326.61(h) – Allows medical waste facilities to accept MSW from homes and workplaces 326.69(a) – Three copies for initial submittal 326.69(a) – Electronic submittals will be allowed when ready No Parts I through IV

27. Registration App(s). Cont. Ch. 330 Ch. 326 Published zoning map- within two miles Mineral interest ownership Buffer zone distance – 50 ft or alternative 326.71(a)(4) – Published zoning map within one mile 326.71(a)(6) – No mineral interest ownership 326.71(h)(3) – Buffer zone distance - 25 ft or alternative and exception for refrigerated transport units

28. Registration App(s). Cont. Ch. 330 Ch. 326 Stationary compactor language is not clear Operating hours and waste acceptance hours Windblown material & litter, once per day, throughout the facility, along fences & access roads or portable fence/or other Materials along the route to facility, within two miles 326.75(d)(4) – Stationary compactor language clarified that it is optional 326.75(i) – Only operating hours 326.75(k) – Windblown material & litter, cleanup as necessary, within reg. boundary Removed the clean-up requirement for materials along the route to facility

29. Location Restrictions Easements & Buffer Zones Airport Safety Floodplains & Wetlands Groundwater & Geology Narratives Endangered or Threatened Species Unstable Areas, Coastal Areas Fault Areas, Seismic Impact Zones

30. How to Comply?

32. Submit 60 day before commencing operations

33. How to Comply?

35. Next Steps  Update the MSW Topics website & guidance documents related to medical waste  Revise the existing forms to mirror the new Chapter  Create new checklists for registration level applications

36. Gulay Aki, P.E. Gulay.Aki@tceq.texas.gov or (512) 239-2340 Mario Perez Mario.Perez@tceq.texas.gov or (512) 239-6681 Contacts: