Automated Microbiology Tools to Support Find and Fix Approach Under the RTCR

Transcription

1 Automated Microbiology Tools to Support Find and Fix Approach Under the RTCR Dr. Peter Gallant, VP Regulatory Affairs ENDETEC / Veolia Water Solutions & Technologies CA-NV AWWA Annual Conference October, 2013

2 Agenda 1. Automated Micro Methods: From the Lab to the Field 2. Field Microbiology RTCR Find and Fix Approach: Pathways and Process 3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab 5. Summary and Key Take-Aways 02/10/2013 2

3 1. Automated Micro Methods: From the Lab to the Field All current EPA-approved Total Coliform Rule analytical methods (40 CFR 141) for E. coli and Total Coliform are manual methods requiring visual interpretation of results. In the next several years, a number of promising technologies will yield new analytical methods that will be highly automated, rapid and sensitive capable of on-site deployment. Micro will be able to move from the Lab to the Field new tools to support find and fix approach under the RTCR. New treatment process diagnostic tool (recent field trial data). 02/10/2013 3

4 1. Moving Microbiology from the Lab to the Field ENDETEC TECTA B-16 Unit and Test Cartridges 02/10/2013 4

5 1. Automated Micro Methods: From the Lab to the Field (ENDETEC TECTA technology) Polymer sensor extracts fluorescent product from water, facilitating rapid detection either visually or with simple instrument. Under UV light, positive (top) and negative (bottom) results Patented in the US and 13 European countries Additional patents pending 02/10/2013 5

6 Signal (%) 1. Automated Micro Methods: From the Lab to the Field (ENDETEC TECTA technology) Continuous sample monitoring by instrument throughout incubation phase for real-time alerting. Can see the enzyme expression / growth curves. Underlying micro count (CFU/ml) directly related to time-to-result (hh:mm) Detection of E.coli in Surface Water 300 cells 100 cells Threshold for Positive 30 cells cells Time (hr) 02/10/2013 6

7 1. Automated Micro Methods: From the Lab to the Field (other automated methods) qpcr increasing use for recreational water monitoring (BEACH Act, 2012). Optical systems (MALS, multi-spectral analysis, zero-angle particle scattering). Numerous groups working on Biochips using combination of selective binding (ligands, antigens) and optical or electronic detection. Source: Bashir, Electronic Micro-fluidic Biochips for Detection of Bacteria 02/10/2013 7

8 1. Why Automate Micro? Provide 24/7 availability of micro testing capability encourage operational monitoring. Provide same level of testing capability for routine micro for small, remote systems as for larger systems. We know our water quality from 8:30am to 4:30pm, Monday to Thursday Anonymous System Operator Appropriately-trained operators are perfectly capable of effectively running this type of automated microbiology method in the field. 02/10/2013 8

9 2. Field Microbiology and Find and Fix Under the RTCR in the Distribution System RTCR Distribution System monitoring results will trigger assessments (Level 1 and Level 2). Trigger for a Level 1 Assessment: Exceed 5.0 % total coliform positive samples for a month Have 2 positive samples for total coliform in one month (for systems collecting 40 samples each month) Trigger for a Level 2 Assessment: E.coli MCL violation Second Level 1 assessment in a rolling 12-month period, or 2 consecutive years, without correcting any problems 02/10/2013 9

10 2. Field Microbiology and Find and Fix Under the RTCR in the Distribution System RTCR focus is on Pathways, not Pathogens (Burlingame ASDWA Presentation, 2010) The proposed RTCR aims to increase public health protection through the reduction of potential pathways of entry for fecal contamination into the distribution system. Since these potential pathways represent vulnerabilities in the distribution system whereby fecal contamination and/or waterborne pathogens, including bacteria, viruses and parasitic protozoa could possibly enter the system, the reduction of these pathways in general should lead to reduced exposure and associated risk from these contaminants. (40928) 02/10/

11 2. Field Microbiology and Find and Fix Under the RTCR in the Distribution System Automated microbiological testing systems could play a major role in Level 1 (selfassessment) and Level 2 (external assessment) sanitary surveys. Deploy system rapidly after initial adverse results. Acquire samples at multiple sample points around source of adverse, including upstream/downstream, storage tanks, etc. allow for a daily micro snapshot of system as part of survey. Use rapid results and on-site capability to rapidly pinpoint source of sanitary defect. 02/10/

12 3. Micro at the Plant: Monitoring Multi- Barrier Treatment Processes RTCR is focused on the distribution system, but what about monitoring the efficacy of the multi-barrier treatment process itself? Significant interest among operators in areas where water reclaim / indirect or direct water re-use is being implemented or considered. High-frequency (every 6 hr.) sampling by plant operator staff (keyed to water residence time in plant), analysis automated micro unit on-site (field trial starting in November in Ottawa). Provides a complete production quality assurance snapshot of treatment process before water product enters the distribution system like food/beverage industry QA/QC in that sense. 02/10/

13 3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes WW reclaim plant, Australia TECTA used by operator 02/10/

14 3. Micro at the Plant: Monitoring Multi-Barrier Treatment Processes Detection times in hours longer times = lower micro count. High count source water results in less than 4 hours. Improved reagents now give all results in < 18 hours. 02/10/

15 3. Micro at the Plant: Studies Recently Completed Multiple Studies of the ENDETEC method: EPA Alternate Test Procedure study run at Pinellas County Utilities report submitted to US EPA for consideration as a TCR approved analytical method. Battelle / Columbus Water Environmental Technology Verification (ETV) study comparing method performance to Colilert-18 under in-plant testing conditions. Sneak Peek: results in hours! Plus: results from on-site use at Tucson and Las Vegas. Results of these studies to appear in upcoming conferences... 02/10/

16 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab First automated methods are arriving at EPA s doorstep for approval. Fostering development of new technologies a key component of EPA Drinking Water Strategy. Can EPA-approved automated methods be used on-site for compliance purposes? This would nominally require site-level accreditation / certification satellite lab sites? How will regulatory agencies deal with the vast amounts of data that automated sensor networks will produce? Are adverse results from operational monitoring using these systems reportable (ethically, if not legally)? 02/10/

17 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Could use laboratory certification process to create mini accredited labs within even small treatment facilities. Risk of burden on state accreditation resources. Complexity of accreditation and costs of maintaining may be a barrier to adoption, particularly for small systems. Personnel and other requirements for full accreditation (to ISO 17025) is a potential barrier (personnel, etc.) Could a standardized framework provide an effective standard of care and performance while maintaining accessibility? What would a framework look like? 02/10/

18 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Approved Methods Validation / Pilots 02/10/

19 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification Approved Methods Validation / Pilots 02/10/

20 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification Approved Methods Accreditation & Auditing Validation / Pilots 02/10/

21 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification QA/QC & System Built-In Test Approved Methods Validation / Pilots Accreditation & Auditing 02/10/

22 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification QA/QC & System Built-In Test Reporting & Data Exchange Approved Methods Validation / Pilots Accreditation & Auditing 02/10/

23 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification QA/QC & System Built-In Test Reporting & Data Exchange Approved Methods Validation / Pilots Accreditation & Auditing Proficiency Testing 02/10/

24 4. Field Microbiology and Compliance: Developing a Framework for Certification Outside the Lab Operator Training & Certification QA/QC & System Built-In Test Reporting & Data Exchange Approved Methods Validation / Pilots Accreditation & Auditing Proficiency Testing Other Elements of Complete Framework? 02/10/

25 5. Summary and Key Take-Aways Right Now: Potential application in taking rapid, repeat microbial snapshots of distribution systems for Level 1 and Level 2 assessments under the RTCR. Find and Fix is about both pathways and processes. Ability to monitor each stage of a multi-barrier treatment system to demonstrate efficacy / microbial takedown. Future: Automated methods for TCR E.coli / Total Coliform testing will soon be available and (hopefully) approved. Need a regulatory framework (adapted from ISO / lab cert best practices) to enable compliance reporting of results obtained from automated micro systems this is the future! 02/10/

26 Contact Information Dr. Peter Gallant Vice-President, Regulatory Affairs ENDETEC Global Sensor Platform Veolia Water Solutions & Technologies 02/10/