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The Decontamination and Remediation of US Facilities contaminated with Anthrax following 9/11 Murray Nicholson STERIS Corporation Workshop on the Biology.

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Presentation on theme: "The Decontamination and Remediation of US Facilities contaminated with Anthrax following 9/11 Murray Nicholson STERIS Corporation Workshop on the Biology."— Presentation transcript:

1 The Decontamination and Remediation of US Facilities contaminated with Anthrax following 9/11 Murray Nicholson STERIS Corporation Workshop on the Biology of Anthrax March 2014

2 Overview Corporate overview Anthrax incidences post 9/11 US Federal Government – Crisis exemption Remedial Action Planning process Decontamination Technologies Case Study – US Department of State Mail Facility Conclusion

3 3 STERIS Corporation - Overview Develops, manufactures and markets infection prevention, contamination control, products and technologies and critical care support products. Serves healthcare, pharmaceutical, life sciences research, industrial, military and aerospace customers throughout the world. Following 9/11 attacks in USA, STERIS established Defence and Aerospace Division to work with Government authorities, Military and private industry to provide biological and chemical decontamination technologies and remediation solutions.

4 STERIS experience and response following Anthrax incidences in October 2001: STERIS technologies and bio-decontamination services were deployed to remediate following Anthrax contaminated facilities in USA in 2001: 1. US Government Mail Facility, GSA Bldg - 410, Washington DC 2. U.S. State Department Mail Facility, SA-32, Sterling, Virginia. 3. N.B.C. TV Studios, Rockefeller Plaza, New York (asset recovery) STERIS Multiple technologies were used - VHP Bio-decontamination systems for enclosures, HVAC etc - Ethylene Oxide vacuum sterilization for absorbent materials and assets - Liquid chemistries for gross contamination, ‘hot zones’ & surfaces Note: Other Anthrax contaminated facilities deployed other gaseous technologies such as chlorine dioxide and formaldehyde

5  1.4 million cubic feet (40,000 m 3 )  Building contents left in place after remediation  Building segmented into zones of approx. 200,000 cu. Ft. (5,700 m 3 ) 1. US Government Mail Facility General Services Administration Building 410

6  1.5 million cubic feet (42,850 m 3 )  Building segmented into zones of approx. 200,000 cu. ft. (5,700 m 3 )  ALL building contents removed post remediation 2. US Department of State Mail Facility SA-32

7 3. NBC National Broadcasting Corporation, New York - Asset Recovery Programme NBC TV studios – Offices Decontamination and asset recovery programme. Designated Anthrax contaminated materials boxed and removed off site to STERIS facility for bulk ethylene oxide sterilization. Valuable assets were sterilized including a wide range of packaged materials: video tapes, files, personal items, artifacts, clothing, photographs, computers etc. - articles designated for recovery.

8 US EPA (Environmental Protection Agency) ‘Crisis Exemption’ In USA, STERIS business activities require us to ensure our products and processes are accepted by the US Food and Drug Administration (FDA) and registered for specific uses by the US Environmental protection Agency (EPA). As a result of the Anthrax incidences, STERIS had to apply and were awarded FIFRA ‘crisis exemptions’ on case by case basis from the US EPA to permit our technologies and methodologies to be used in the decontamination of buildings, mail facilities and National Broadcast private Industries that had been the target of terrorist attacks on. For each project undertaken STERIS were successful during the scientific evaluation, completion of the decontamination process and delivery of the project expectations, on time and on budget.

9 Vaporized Hydrogen Peroxide (VHP) was selected as the best available option for our facility, based upon an evaluation of the major fumigants available for use in anthrax decontamination efforts. Key evaluation criteria were safety factors, such as risk to community, toxicity, and industry experience with the fumigant. Vaporized hydrogen peroxide has been proven to be effective in treating anthrax contamination. Office of the Spokesman Washington, DC

10 Typical Model Format for a Remedial Action Plan for facility fumigation of Bacillus Anthracis Background - Facility description, surroundings, environment, responsible agencies, stakeholders, objectives of remedial action plan, extent of contamination. Characterization Environmental Sampling – Sampling strategy, ID and mapping contamination locations and levels Remedial work plan – Risk assessment- worker safety, public safety, protocols, emergency response plan agreed by all parties Site Preparation and Spore reduction – containment of facility, removal of materials & assets for recovery/disposal – surface treatment of gross contamination and facility remediation Fumigation Process – fumigant delivery, safety considerations, monitoring of process variables, placement of Biological (BI)and Chemical indicators(CI) for cycle verification, environmental monitoring during process, removal of fumigant, evaluate effectiveness of fumigation process. Environmental Sampling – post-sampling strategy, surface/air samples, verification of results, criteria to declare fumigation process successful and permitting re-entry.

11 STERIS decontamination technologies deployed against Bacillus Anthracis spores EPA registered products that have passed rigorous AOAC sporicidal testing, demonstrate good material compatibility and area coverage. Liquid based technologies for surfaces, walls, floors, ceilings and gross contamination areas SporKlenz ® RTU sporicidal liquid (PAA/H202) Gaseous based technologies for surfaces, HVAC air handling system and environment. Process must be compatible with materials of construction, equipment including delicate materials, fabrics, and sensitive electronics devices etc. Must have proven health and safety profile. VHP ® (Vaporized Hydrogen Peroxide) Technology for facility decontamination ETO (Ethylene Oxide) Vacuum Sterilization for the ‘off site’ sterilization of porous materials and assets Decontamination processes are validated using biological and chemical indicators, gas concentration monitors and the cycle process parameters

12 12 VHP™ (Vaporized Hydrogen Peroxide) Technology A low temperature dry vapour process Sporicidal process that destroys the full spectrum of biological contaminants Environmentally friendly, validatable process. Compatible with a wide variety of materials of construction. No residues – only water vapour and oxygen.

13 1. Dehumidification Phase Reduce condensation formation of the hydrogen peroxide Recommended for high humidity and/or cold temperature applications. 2. Conditioning Phase Initiation of hydrogen peroxide vapor, High injection rate to rapidly reach target concentration 3. Decontamination Phase Timed phase at target concentration to ensure site is exposed to decontaminant for at least the min. exposure time 4. Aeration Phase Hydrogen peroxide injection stopped, residuals catalytically broken down to water vapor and oxygen The VHP Biodecontamination Process

14 Key factors for fumigant selection Demonstrated Efficacy Safety profile to community and environment Industry/Vendor Experience Technical Complexity Toxicity Ease of Monitoring Emergency Response Liability Availability Price

15 Case Study - US Department of State Mail Facility Background In October 2001, The US Department of State’s Mail Facility (SA-32) in Virginia, was contaminated with Bacillus Anthracis

16 Facility Description The Department of State’s Mail Facility is a sorting, collection, and distribution point for US diplomatic mail, sent to and from US Embassies. Employees: approximately 80 Dimensions: 1.4 million cu ft. (40,000m 3 ) Primary Facility Equipment: –Flat Mail Sorters –Parcel Sorters –Rolling Stock –Cabinets

17 Facility scenario A Department of State (DoS) contract employee was diagnosed with inhalational Anthrax in October 2001. The building was closed and sealed. Mail operations were relocated to a temporary facility. From October 2001 to November 2001, the Centres for Disease Control and Prevention and DOS contractors collected samples. Positive areas in the facility were identified; highest concentration found in and around Mail Sorter 3. Actual remediation work commenced in fall of 2002.

18 Project Recovery and Remediation Planning Groups Technical Working Group (TWG) – advises on development and implementation of plans for decontamination Specialized Sub-Committees - Waste Disposal, Fumigation, Air Monitoring, Sampling, Emergency Preparedness, and Risk Communication Environmental Clearance Committee (ECC) – monitors decontamination efforts, reviews sampling results, and recommends whether building is safe for re-occupancy

19 Agency/Member Technical Working Group & Clearance Committee included: - Department of State - State of Virginia - Loudoun County, VA - EPA (Environmental Protection Agency) - CDC – NIOSH (National Institute for Occupational Safety & Health) - CDC – NCID (National Centre for Infectious Diseases) - OSHA (Occupational Safety & Health Administration) - CDC – ATSDR (Agency for Toxic Substances & Disease Registry) - GSA (General Services Administration) - U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) - U.S. Army Centre for Health Promotion and Preventive Medicine (USACHPPM) - U.S. Army Corps of Engineers (USACE) Rapid Response Program - Private Sector Members

20 Letter Sorting Machine Area 17 positives Acceptance Dock Area 1 positive Personnel Staging Area 2 positives WorkStation Area 1 positive Pigeon Hole Area 6 positives Initial Sampling location map

21 Methods used for facility decontamination Combination of methods deployed for decontamination -HEPA Vacuuming or surface liquid treatment (depending on level of contaminant) to reduce gross bioburden levels -Sterilization offsite - Boxing up of absorbable porous materials (47,000 diplomat mail pouches) in heavily contaminated areas and sterilized offsite by irradiation, ethylene oxide or terminal destruction. -Liquid Sporicidal treatment - Preparation of area for gas fumigation especially ‘hot spots’ with initial pretreatment of liquid sporicidal agents. -Gaseous Fumigation - Area, room and HVAC ductwork fumigated with gaseous sporicidal process -Process Verification effectiveness by process monitoring of sterilization parameters and use of BI/CIs Facility was decontaminated prior to removal of contents and then divided into 7 zones (each approx 5,700 m 3 ). This was followed by additional decontamination cycles.

22 SA-32 Building Sealed Air Tight Prior to Fumigation

23 Before After Removal of building contents

24 Before After Removal of building contents

25 Enclosure Partition Interior partitioned into 7 zones

26 Negative Air Machine VHP Generator VHP Biodecontamination system positioned external to facility

27 Sampling data and results provided to ECC for review & recommendation on success of decontamination and clearance for re-occupation Phase 1 - Surface Sampling (wipes, swabs, HEPA vacuum) Phase 2 - Air Sampling (Teflon Air Cassette, Dry Filter Units, Mattson-Garver Slit-to-Agar) Phase 3 - Zone Partition Surfaces Sampling 619 samples were be collected – all negative for growth of anthrax spores Post Decontamination Sampling Phases

28 Post Decontamination Sampling

29 Total Clean-up Cost: $8.6 million - 65% Waste Disposal (>400 tons) - 9% Post-fumigation sampling - 26% Fumigation & Air Monitoring Total Impact Cost: $21 million Clean-up Cost Summary

30 2. Letter to DOS from Environmental Clearance Committee: “remediation approach utilized was very thorough in design and implementation, using the best science and technology available, to minimize residual risk. The decontamination process was successfully completed and cleared for re-occupancy” Summary 3. Lessons Learned - Use Expert Committee-Agency based guidance - Recovery & remediation plans are time-consuming(17 months) - Project resource intensive - Cost implications, facility and assets recovery justifications - Need for a robust response & recovery guidance document 1. The project was a success because of the Inter-Agency and Private Industry expertise and cooperation.

31 A letter of thanks.............

32 32 QUESTIONS


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