medical waste management regulations for the handling, treatment & proper disposal of medical...

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

• Who Regulates Medical Waste in Texas

• “Medical Waste” Definitions

• Types of Authorizations

• Application Contents/Processing

• Ebola Experience 2014

AGENDA

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

• 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

• 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

– 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

DEFINITION - TCEQ

Exceptions

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

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)

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

• 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

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

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

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

•Ebola in the U.S.

• Task Force on Infectious Disease Preparedness and Response

• TCEQ’s role

• Conclusion - Task Force Report & Recommendations

EBOLA EXPERIENCE 2014

• 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.

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

• Classification of Ebola contaminated material

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

SAMPLE QUESTIONS FOR TCEQ

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

TCEQ’S RESPONSE

• Efficacy for each type of treatment – incineration preferred

• Disposal options – ash

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

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

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:

• 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