NHICEP Conference NH Hospital Association September 15, 2009

1. NHICEP ConferenceNH Hospital AssociationSeptember 15, 2009 Cleaning Chemicals: Risk, Cleanliness Testing and EPA Regulatory Update Jack Fellman Greener Chemistry Associates LLC

2. Topics for Discussion • Chemical Risk Assessment Model • ATP Bioluminescence Test Method • U.S. EPA Actions • July 30, 2009 Regulatory Update-Antimicrobial Labeling Update (Joan Harrigan-Farrelly, Director) • June 12, 2009 Pesticide News Story: antimicrobial Testing Program Web Page Now Available • July 31, 2009 EPA Reaches Settlement with Nation’s Largest Manufacturer of Hospital Disinfectants; Company Agrees to Pay $550,000 in Penalties

3. Chemical Risk Assessment Model

4. GCA Cleaning Product Risk Assessment Considerations • Health • Environment • Potential For Exposure of Personnel • Storage & Handling • Product Cost/Working Gallon • Product Performance

5. GCA Cleaning Product Risk Assessment Objectives • Reduce Health and Environmental risks • Reduce potential personnel exposure • Product upgrade should be cost neutral • Increase usage of 3rd party certified products or better

6. What is a GCA Chemical Risk Assessment? • A methodto quantify the riskto personnel and the environment of using a chemical for a cleaning function • A tool to facilitate the comparison of one product to another for the same potential use • A lower number for the risk assessment indicates a safer chemical • Water would have a GCA rating of zero

7. Criteria for GCA Risk Assessments • The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) • EPA/s Design for the Environment (DfE) • Green Seal Certification Standards • Health & Environmental Risk Assessment Project (HERA) • Hodge and Sterner Scale for Toxicity Classes • Arizona State University - Chemical Risk Assessment Form Tool (CRAFT)

8. The GCA Risk Assessment Process Steps • Product is identifiedwith the MSDS • Hazardous ingredients are determined • Risk assessments of individual hazardous ingredients are made • Data for individual ingredients are combined to produce a product risk assessment • Typical application data (i.e., 1 gallon/hour) is used to calculateand compare the estimated exposure to documented exposure limits (OSHA) • Product cost and typical dilutionsused to calculate cost/working gallon

9. Product is Selected • Product name • MSDS number • Product codes • Recommended use • Manufacturer • Concentrate or Ready to Use • Dilution Ratio • Estimated Usage per Hour

10. Hazardous Ingredients are Identified • Chemical name(s) • CAS Number(s) • % Weight Concentration

11. Component Risk Assessments Risks Acute health effects Chronic health effects Exposure limits Exposure indicators Routes of exposure Physical form Vapor hazard ratio • Hazards • Health • Physical • Degree of Hazard • Flash point • Toxicity • Aquatic Toxicity

12. Product Risk Assessment • Example

13. Product Information

14. Hazardous Components & Summary of GCA Component Assessment

15. Component Risk Assessment

16. Component Risk Assessment

17. Component Risk Assessment

18. Component Risk Assessment

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20. Component Risk Assessment

21. Component Risk Assessment

22. Component Risk Assessment

23. Component Risk Assessment

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25. Component Risk Assessment

26. Component Risk Assessment

27. Component Risk Assessment

28. Component Risk Assessment

29. Component Risk Assessment

30. Component Risk Assessment

31. Exposure Risk Determination

32. Cost Assessment

33. ATP Bioluminescence Test Method

34. How Clean Is It? • Visual assessment is not adequate • Testing for microorganisms is better • Testing takes a relatively long time – not relevant to a “re-clean” possibility if results are not acceptable • Testing requires laboratory facilities and skilled personnel • A new rapid test method must be quick, sensitive and capable of detecting unacceptable cleaning performance • Bioluminescence test for adenosine triphosphate (ATP) has been developed for this need C. Ramsay, Biotrace International July 29, 2003

35. What is ATP and how do we measure it? • ATP is contained in the nucleus of microorganisms • 1947 bioluminescence first reported using the enzyme/substrate of firefly (luciferase/luciferin) to detect ATP • Methods developed to provide a linear relationship between luminescence intensity and ATP concentration • Reagent chemistry and portable instrumentation refined for a rapid test

36. Reaction for Light Measurement • Luciferin + Luciferase + ATP + Mg++ -> (Luciferin-Luciferase-AMP) + Pyrophosphate • (Luciferin-Luciferase-AMP) + O2 -> Oxyluciferin + Luciferase + CO2 + AMP + Light

37. New Portable Cleaning Test System • The New Portable Cleaning Test System is a tool to help healthcare professionals address the question, “How can I feel comfortable a surface has been properly cleaned?” • The technology of ATP bioluminescence is an accepted method for protein detection and it has been made portable with “real time results”. • In only 30 seconds, a quantifiable result is available to provide “peace of mind” or to “initiate corrective action”.

38. How does it work? • Swab without ATP is pre-moistened • Swab is wiped across a surface, approximately 4” x 4” in area • Contaminated swab is placed in contact with luciferin/luciferase reagents • Swab is then placed in the portable luminescence meter • Readings in Relative Light Units (RLUs) are available in 30 seconds

39. How long can contaminated swabs be held before analysis? • Up to 4 hours • The contaminated swab can be placed back in the packaging tube and taken with other samples to a “workstation”, if preferred

40. Is monitoring hospital cleaning practices with New Portable Cleaning Test system “effective”? • Study by Boyce, et. al., Hospital of Saint Raphael and Yale University School of Medicine • Conclusions: • The ATP bioluminescence assay method of the study gave quantitative assessment of cleanliness • The ATP method can be used for training purposes • The ATP method can provide feedback in “real-time” • Digital readings with data analysis software provide data tracking

41. How does the New Portable Cleaning Test System compare to other methods for “sensitivity”? • Independent study by Simpson and Giles, Cara Technology, Ltd (2006) “Protocol for assessing the sensitivity of hygiene test systems for live microorganisms and food residue”. • Conclusions: • The New Portable Cleaning Test System has better sensitivity to low level contamination and repeatability for food residues and microorganisms. • A similar instrument produced almost 60% false negatives based on the samples tested: serial dilutions of Staphylococcus aureus, Citrobacter freundii, Zagosaccharomyce bailiis, Yeast extract and Yogurt drink, with manufacturer recommended pass/fail limits, for each dilution level.

42. How does the New Portable cleaning Test System compare to other systems for “repeatability”? • Independent study by Simpson and Giles, Cara Technology, Ltd (2006), “The repeatability of hygiene test systems in measurement of low levels of ATP”. • Conclusions • 30 tests on each of 4 different systems, concluded that the New Portable Cleaning Test System had the lowest Coefficient of Variation (%CV) and was more repeatable. • %CV = 7.4, 38.1, 58.7, 89.4

43. Features/Benefits of New Portable Cleaning Test System

44. Field Experience with the New ATP Test System • One local user reported a decrease in MRSA cases from about 9 per month to 2 per month, since they started using the New ATP Test System

45. “Infection Control QA in the Patient Care Environment using ATP Bioluminescent Technology” Mark Gallivan, Un of Minnesota • Sampling 610 Samples • To compare the RLUs of occupied vs discharged patient rooms • Location 4 Different Wards • Bone marrow transplant • Neurology • Solid organ transplant • Medical intensive care • Surfaces 5 Different Surfaces • Bedrail • Keyboard • Treatment cart • Bathroom door knob • Toilet flush handle

46. “Infection Control QA in the Patient Care Environment using ATP Bioluminescent Technology” Mark Gallivan, Un of Minnesota

47. “Infection Control QA in the Patient Care Environment using ATP Bioluminescent Technology” Mark Gallivan, Un of Minnesota • Sensitivity • Capable of detecting clean and unclean surfaces • High Variability • Data skewed to the right from high outliers • Real Time Monitoring of Protocol • Capable of achieving p < 0.05 results • Comparability of Surfaces • Not valid due to surface area and type • Creation of Baseline RLU Values • Should be created for individual surfaces

48. U.S. EPA Actions

49. Antimicrobial Labeling Update From U.S. EPA • July 30, 2009 • Presented by: • Joan Harrigan-Farrelly, Antimicrobial Div. Director • Dennis Edwards, Chief, Regulatory Management Branch 1, Antimicrobials Division • Ben Chambliss, Microbiologist, Antimicrobial Div. • Tajah Blackburn, Team Leader, Efficacy Team, Product Science Branch, Antimicrobials Division

50. Presentation Overview • How EPA regulates Antimicrobials • How EPA ensures product efficacy for hospital disinfectants • Overview of EPA’s Antimicrobials Test Program • Availability of Information on the Antimicrobial Program • Antimicrobial Division’s Hospital Community Outreach Initiative • How can AD best communicate with hospital community and maintain an open forum for future discussions?