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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

MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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Page 1: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 2: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• Who Regulates Medical Waste in Texas

• “Medical Waste” Definitions

• Types of Authorizations

• Application Contents/Processing

• Ebola Experience 2014

AGENDA

Page 3: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

REGULATORY AGENCIES

TCEQOther 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

Page 4: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• 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

Page 5: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• 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

Page 6: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

– 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

Page 7: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

DEFINITION - TCEQ

Exceptions

Page 8: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

TCEQ Authorizations

NotificationRegistration by

RuleMSW 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

Page 9: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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)

Page 10: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 11: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• 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

Page 12: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 13: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 14: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

TYPE V REG. APPLICATION PROCESS

Application Determined Preliminarily Complete

Initial Technical Review

45 Day NAORPM Mailed/Published

Comment/Meeting Request Period (60 Days)

NOD Process

Public Meeting if Requested

Declaration of Technical Completeness

Final Action

Page 15: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

•Ebola in the U.S.

• Task Force on Infectious Disease Preparedness and Response

• TCEQ’s role

• Conclusion - Task Force Report & Recommendations

EBOLA EXPERIENCE 2014

Page 16: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• 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.

Page 17: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 18: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• Classification of Ebola contaminated material

• List of treatment & disposal facilities • Treatment options & how effective• Packaging/Labeling requirements

SAMPLE QUESTIONS FOR TCEQ

Page 19: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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

Page 20: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

TCEQ’S RESPONSE

• Efficacy for each type of treatment – incineration preferred

• Disposal options – ash

• Packaging & Labeling – DOT Cat A Example - Triple Packaging

Page 21: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

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• 84th Legislature – Proposed HB 2950 & SB 538

TASK FORCE RECOMMENDATIONS CONCLUSION

Page 22: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

Mario Perez

[email protected]

or (512) 239-6681

Daniela Ortiz de Montellano

[email protected]

or (512) 239-2210

CONTACTS:

Page 23: MEDICAL WASTE MANAGEMENT REGULATIONS FOR THE HANDLING, TREATMENT & PROPER DISPOSAL OF MEDICAL WASTE, INCLUDING EBOLA WASTE Daniela Ortiz de Montellano

• http://www.tceq.texas.gov/permitting/waste_permits/msw_permits/mw_disposal.html - checklists & other info

• https://www.tceq.texas.gov/publications/rg/rg-001.html - Texas regulatory guidance document on medical waste

REFERENCES