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NBSA SYMPOSIUM
6 NYCRR Part 365REGULATED MEDICAL WASTE AND OTHER
INFECTIOUS WASTES
Alan G. Woodard, Ph.D.Research ScientistMarch 21, 2019
Did you know? The human senses of sight, smell, taste, hearing and touch cannot detect the presence of infectious agents.
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Revised 6 NYCRR Part 360 Regulations
The new regulations became effective on 11/4/17
Existing registered facilities had 180 days to apply for
renewal
Existing permitted facilities permit continues until renewal or modification
Existing exempt/registered facility now requiring permit should have had a complete application on file with the DEC within 365 days
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Part 360 Revised Series Structure
General RequirementsPart 360
Material Recovery FacilitiesPart 361Combustion, Thermal Treatment, Transfer, and Collection FacilitiesPart 362
LandfillsPart 363
Waste TransportersPart 364Regulated Medical Waste and Other Infectious WastesPart 365
Local Solid Waste Management PlanningPart 366
State Assistance ProjectsPart 369
http://www.dec.ny.gov/regs/2491.htmlURL
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Part 360 Series Applicable to RMW & OIW
RPart 360Series
General Requirements
360.2(b)Definitions
(43)
Part 365
Parts 362 & 363
Part 364
Regulations
• Replaces previous Subparts 360 ‐10 & 17
• Updates & adds applicable definitions
• Replaces generator standards in Part 364
• Adds new requirements and conforms with other state and federal regulations
• Addresses incidental infectious waste that is not RMW
• Subpart 365‐1 RMW Generators
• Subpart 365‐2 RMW Treatment, Storage, & Transfer Facilities
• Subpart 365‐3 Other Infectious Waste
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Part 360.2(b) Definitions Applicable to RMW & OIW
Alternative treatment systemAnimal research facilityAutoclaveBioburdenBio‐challenge testingBiological drug wasteBiological indicatorBiologicalsBiosafety levelBulk outer packagingCertificate of treatmentClinical laboratoryCultures and stocksCycle
DecontaminationDestroyedDisinfectantDisinfectionForeign animal disease wasteGeneratorHousehold medical wasteInfectious substanceInstitutional wasteLeak‐proofParametric controlPathogenic organismsPatient care areaPharmaceutical waste
Primary containerRadio‐pharmacyRegulated medical wasteReprocessedResidence timeSecondary containerSelect agent or toxinSharpStorage areaThermal treatmentToxic drug wasteToxinTreated regulated medical wasteTreatmentValidation testing
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360.2(b) Definitions
Waste generated in the diagnosis, treatment, immunization of humans & animals, research {Risk Groups 2‐4} pertaining thereto, or in the production and testing of biologicals; provided, however, that regulated medical waste must not include hazardous waste and household medical waste.
(228) Regulated Medical Waste Other Infectious WastesIncidental waste that is not RMW butthat has come into contact with an infectiousagent. It means any waste generated as a consequence of mitigating exposure to infectious agents (e.g., including waste from work spaces, living spaces, and other similar locations prior to re‐occupancy, etc.). It includes any agent classified as Risk Group, 2, 3, or 4 by the NIH in their Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. {Proposed inclusion of APHIS regulated garbage and organisms}
7NYS Universe of Regulated Medical Waste
Select Agent/ Biological Toxin Waste
RMW Not RMW
Cultures & StocksHuman Pathological Waste
Human Blood & Blood Products
Sharps
Animal WasteOther Waste
16 Waste Materials including:
• Human cadavers• Home generated veterinary, self
administered medical materials &Pharmaceutical waste
• Contaminated foodstuffs• Used healthcare products sent to
manufacturer• Fixed cytological materials• Certain pathological waste• Environmental, quality control
& food samples
BSL 3 & 4
Waste
RMW ?Trauma/CrimeScene Waste
Blood soakedmaterials & sharps
from tattooparlors, etc.
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RMW Cultures & Stocks
Human Pathological
Waste
Animal Waste
Related Waste
Human Blood & Blood Products
Sharps
Other Infectious Wastes
Part 365 Universe of Waste Potentially Contaminated with Infectious Agents
Food/Agricultural Residues
Indirect & Aqueous Residues
Waste Treated in situ with
Decon Process
Waste from Work and Living Spaces
Mass Animal Mortalities
Select Agent/ Biological Toxin
Waste
Natural Disaster Waste
Residential Waste
Research & Lab Waste
Waste Removed &
Treated ex situ
Vehicles/Soil/Vegetation
Incident InfectiousWaste
Trauma/Crime Scene Waste
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Subpart 365-1 RMW Generators
Applies to all persons who generate RMW except certain facilities regulated by NYSDOH under 10 NYCRR Part 70
Requires generators to develop a written waste management plan
Adds containment requirements and storage time frames
Identifies primary and secondary container requirements (including bulk containers)
Includes provisions for transfer of RMW for off‐site treatment
365‐1.2(a) Waste management
plan
365‐1.2(b) Containment &
storage
365‐1.2(c) Transfer of RMW for off‐site
treatment
365‐1.2(d) Treatment on‐
site
365‐1.2(e) Recordkeeping &
reporting
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Subdivision 365-1.2(b) Generator Containment & Storage requirements
• 24 hours for RMW (except sharps) in patient care or use areas • 72 hours for RMW in laboratories• 90 days for sharps (unless container is filled or generates odors)• 30 days for any RMW in storage area• 60 days in storage area if less than 50 pounds/month• 21 days for bulk packages (roll‐off containers) if below 45 degrees• 14 days for bulk packages if above 45 degrees
365‐1.2(b)(7) & (8)Current
Enforcement Discretion
Proposed tobe amended
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RMW Management
Unacceptable
Acceptable
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365-1.2(c)(7) RMW & infectious substance packaging and labeling
OSHA’s Universal Biohazard Symbol
The word “Biohazard”
The proper shipping name
The UN identification number
RMW
Infectious Substance(Category A/B)
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Synopsis of Generator Requirements 364‐3.1, 365‐1.2 & 365‐2
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Subpart 365-2 RMW Treatment, Storage, & Transfer Facilities
Provided The facility only manages its own waste.
‐ Clinical Laboratories; and
‐ Diagnostic & Treatment Centers;
‐ Residential Healthcare Facilities;
‐ Hospitals (Except Veterans Health Administration Hospitals);
EXCEPT: Facilities defined and regulated by PHL, located at and operated by:
Section 365‐2.1 Applicability
Applicable to all facilities that treat, store or transfer RMW
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Section 365-2.2 Exempt facilities
Sharps and pharmaceutical drop boxes, and kiosks used by homeowners
Storage or transfer at site of generation in
accordance with 365‐1
Source separated used medical devices by the generator sent directly to a manufacturer or re‐processor
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Section 365-2.3 Registered facilities
365‐2.3(a): Storage of radiological RMW at radio‐pharmacies.
365‐2.3(b): On‐site treatment of less than 500 pounds of RMW/month, except facilities operating at BSL 3 or 4, or treating select agents or toxins
365‐2.3(c): Licensed healthcare facilities (pursuant to PHL) that treat, store or dispose of RMW from other generators or are not operated by the healthcare facility.
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Section 365-2.4 Permitted Facilities
On‐site and off‐site storage, transfer or treatment of RMW
Treatment of RMW delivered by permitted Part 364 transporters
Storage, transfer or treatment of Select Agents and Biological Toxins
Waste from BSL3 or 4 labs
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Section 365-2.4 Permit
application requirements
Compliance with 360.16 and include the following in
accordance with Part 365:
‐Waste control plan ‐ Operation and maintenance plan;
‐ Personnel training and safety plan; ‐ Contingency plan; ‐Wash‐water
management plan;
‐ Description of treatment equipment;
‐ Validation testing plan; and ‐ Closure plan
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Section 365-2.5 Design & operating requirements
A RMW tracking document must accompany each waste load
Waste must pass through a fixed portal radiation detection system
Bulk packages may not be accepted unless authorized
Controlled handling and storage at all times
RMW recovery and recycling of used medical devices or emptying of containers must employ robotic or mechanical equipment
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Section 365-2.6General treatment requirements
Treatment includes:
Discharge of liquid or semi‐solid to sanitary sewer system;
Discharge of liquid or semi‐solid to an effluent decontamination system;
Incineration in accordance with Subpart 362‐1;
Decontamination by autoclaving; or
Decontamination with an alternative treatment system approved by NYSDOH
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Section 365-2.6 General treatment requirements
Treated waste can be disposed as MSW (commercial waste) if:Treated waste can be disposed as MSW (commercial waste) if:
• Accompanied by NYSDOH Certificate of Treatment (CT)
• Sharps must be both treated and destroyed (rendered unusable) prior to landfill disposal in NYS
• Sharps that are not destroyed must be accompanied by a Medical Waste Tracking Form and a CT and can be combusted
• Disposed at a facility authorized to accept treated RMW
• Cultures and stocks containing select agents or non‐exempt quantities of biological toxins must be handled in accordance with Federal Select Agent Program
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Treatment Technologies Used in NYS (Thermal, Chemical, Irradiation, Other)
Microwave Autoclave
Rotoclave
Alkaline Hydrolysis
Sanipak EDS
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365-2.6(b) Restrictions on autoclave use
Cannot be used for:• RMW mixed with hazardous or
pharmaceutical waste• Treatment of radiological waste• Recognizable human organs or
body parts, or animal body parts or carcasses unless approved by DEC or DOH
• Thermally resistant materials such as solidified liquids, or bulk animal bedding exceeding 5 cubic feet
• Biological toxins other than those listed in the BMBL orverified as an effective method for a specific toxin {Proposed amendment}
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365-2.6(i)Validation testing prior to equipment use
Applicable to all
treatment devices
Validation testing with biological indicators
Verification testing of indicators
Three separate test runs
Periodic repeat
validation testing
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365-2.6(h) & (i) Requirements for effective treatment facility testing & operations# BIs for TestingD value = 1.8
6 Log Concentration
Load Size(Pounds)
ConsistentOperational Parameters
Consistent Load Composition
Consistent Load Configuration
Consistent Moisture Content
Three test runs,cycle, duration, heat, chemical, or irradiation exposure time, chemical concentration, etc.;For autoclaves, one or more pre‐vacuum cycles or steam pulses
Porosity, liquids, solids, organic matter, thermal resistance & type of packaging
Packing density, orientation, etc.
Wet or dry consistent with waste to be treated
3 0‐1105 111‐5507 551‐11009 1101‐1650
11 or more >1650
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365-2.6(k)(6) Facility
inspection
‐ Licensed professional engineer
• Inspection results must be included in the annual report
‐ Biosafety specialist, or
‐ Certified industrial hygienist,
Performed by a qualified individual
Annual facility inspection required
27
Section 365-2.7 Synopsis of monitoring for treatment
• Parametric controls (Each Cycle)‐ Real time monitoring devices
• Physical & chemical monitors (Each Cycle)‐ Thermochemical indicators & integrators
• Bio‐challenge testing (Routinely)‐ Biological indicators with verified population
Spore Strips
BI‐Self Contained
Thermo Chemical Indicator Strip
Autoclave Tape
Positive Vs. Negative
Wireless Thermocouples
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365-2.8 Recordkeeping & reporting requirements
A record of RMW managed by quantity & category
1
Retention of electronic records of validation & challenge testing, parametric monitoring, employee training & corrective actions
2
Annual report submittal summarizing RMW managed, waste bypassed to another facility, operational issues and resolutions
3
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Subpart 365-3 Other Infectious Wastes
Applicable to incidental waste that is not RMW (e.g., materials generated as a consequence of mitigating exposure to infectious agents)
• Exempt from permit or registration if stored (as per 365‐1.2) for a period not to exceed 30 days at site of generation
• Registration required if stored at other than the site of generation & for a maximum of 14 days
• Registration required for temporary treatment devices that passes validation testing and used for less than 90 days
• Errors in referencing 365‐4 (corrected in West Law version)
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2014 Ebola Virus Lessons LearnedEVD Patients/Waste
• Emory University 350 bags/3058 lbsover 19 days autoclaved on‐site/CDC
• Bellevue 275 drums over• 1 Month or 5 truckloads (up to
$160,000/truckload)• University Nebraska Medical Ctr
(pass thru autoclave)• Dallas Presbyterian (Incinerate/Port
Arthur)• NIH Bethesda (autoclaved/residue
disposed at Ft. Detrick)
Potential EVD Concerns• Hospital RMW Waste• Residential Waste
‐Wet or dry• Public Spaces? • Non EVD waste • Waste Water/Biosolids• Companion animals/Carcasses• Cadavers• Few trained responders• Waste Packaging• Waste handlers & treatment facilities
unwilling to accept waste
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Microorganisms Most ResistantPrions (protein)CoccidiaSporesMycobacteriaCystsSmall Non‐Enveloped VirusesTrophozoitesGram‐Negative BacteriaFungiLarge Non‐enveloped VirusesGram‐Positive BacteriaLipid Enveloped Viruses
RMW & OIW Treatment & Disposal ApproachEfficacy MeasuresBiological IndicatorsThermocouplesThermochemical IndicatorsParametric Monitoring
Other Infectious Wastes
Treated/Untreated/ Disinfected Waste to Combustion
Indirect & AqueousResidues
Wet/Dry/Chemical/Thermal
Treated Waste/ Residues/Ash to
Landfill
Regulated Medical Waste
in situ Fumigation &ex situ Wet/Dry Chemical/Thermal
EDS
POTW
Least
Treatment Evidence
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Synopsis of RMW and OIW Considerations
Laws & Regulations (Local, State &
Federal)
Waste Management
(On‐Site/Off‐Site)
Disposal(Untreated Waste & Treated Residues)
Generation(Waste Collection & Separation)
• State(s)• USDOT/USEPA• USDA/CDC• OSHA/NIH• USFDA/USPS
•Infectious Waste/Incident • Contamination Characteristics• Spread of Contamination• Dispersion/Resuspension/Tracking• Decontamination• Efficacy/Engineering• Treatment/Handling• Risk Assessment• Social/Economic Impact
• Acceptance Criteria (Public/Private)• Capacity/Compliance • Approvals/Permitted• Liability• Economic Impact
• RMW/Pharmaceutical• Recycling• Chemical/Radioactive• Porous Building Materials• Animal Carcasses• Agricultural Residues• Indirect & Aqueous Residues• Other (Crime/Trauma)
• Packaging/Labeling• Storage/Staging/Transfer• Transport• Treatment/Decontamination• Operations/Monitoring• Reusable Containers• Worker Safety• Permit/Registration/PBR• Special Permit
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QUESTIONS?Please e‐mail any questions to me at:
[email protected] Or call: 518‐402‐8678; And
Contact a DEC Region to Register or Obtain a Permit
http://www.dec.ny.gov/about/50230.html