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
Jan 04, 2016
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
or (512) 239-6681
Daniela Ortiz de Montellano
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