1. 1 NHICEP Conference NH Hospital Association September 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 2

3. Chemical Risk Assessment Model 3

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

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 3 rd party certified products or better 5

6. What is a GCA Chemical Risk Assessment? A method to quantify the risk to 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 6

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) 7

8. The GCA Risk Assessment Process Steps 1. Product is identified with the MSDS 2. Hazardous ingredients are determined 3. Risk assessments of individual hazardous ingredients are made 4. Data for individual ingredients are combined to produce a product risk assessment 5. Typical application data (i.e., 1 gallon/hour) is used to calculate and compare the estimated exposure to documented exposure limits (OSHA) 6. Product cost and typical dilutions used to calculate cost/working gallon 8

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

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

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

12. Product Risk Assessment Example 12

13. Product Information Product Name:ABC7/10/2009 MSDS #:Number Product Code:123456 Use: Cleaning Product Concentrate or RTU:Concentrate Manufacturer:DEF 13

14. Hazardous Components & Summary of GCA Component Assessment Component:12Total Ingredient:Benzyl AlcoholEthanolamine CAS #:100-51-6141-43-5 Max in Product:25%7% GCA Health Hazard830 GCA Physical Hazard22 GCA Degree of Hazard912 GCA Risks5642 GCA Probability of Exposure1419 89105 GCA Product Risk Assessment 194.0 14

15. Component Risk Assessment Chemical Name: Ethanolamine (2-aminoethanol)CAS # 141- 43-5 Hazards: PotentialActual7/10/2009 Health Hazards Carcinogen10 Corrosive22 Irritant22 Sensitizer4 Toxic2 Highly Toxic44 15

16. Component Risk Assessment Target Organ Effect Liver33 Kidney33 Lymphoid system3 Central nervous system33 Blood forming organs3 Respiratory tract33 Lungs33 16

17. Component Risk Assessment Reproductive toxin Teratogen4 Mutagen4 Skin33 Eyes44 Total Health Hazards30 17

18. Component Risk Assessment Physical Hazards Combustible Liquid22 Flammable3 Oxidizer4 Total Physical Hazards:2 18

19. Component Risk Assessment Degree of Hazard: Flash Point ( o F) >2000 150-20011 100-1502 1-1003 <04 19

20. Component Risk Assessment Oral, rat LD 50 (mg/kgbw) >15,0000 5,000-15,0001 500-5,0001,72022 50-5003 1.0-504 <15 20

21. Component Risk Assessment Inhalation, mouse LC 50 (ppm) >100,0000 10,000-100,0001 1,000-10,0002,42022 100-1,0003 10-1004 <105 21

22. Component Risk Assessment Skin, rabbit LD 50 (mg/kg) >22,6000 2,820-22,5901 350-2,8101,00022 44-3403 5.0-434 <5<55 22

23. Component Risk Assessment Corrosivity (pH) 6.0-9.00 5-6 or 9-101 3-5 or 10-122 1-3 or 12-1433 144 23

24. Component Risk Assessment Aquatic Toxicity-Acute (L/E/IC50) >100 ppm00 10-100 ppm1 1-10 ppm2 <1 ppm3 Biological Half-life minutes0 hours1 days22 weeks3 years4 Total Degree of Hazards:12 24

25. Component Risk Assessment Risks: Acute Health Effects Irritation11 Sore throat22 Coughing22 Redness22 Burning44 Pain44 Tearing22 Stinging2 Swelling2 25

26. Component Risk Assessment Nausea33 Vomiting33 Diarrhea3 Headache22 Dizziness2 Narcotic effect33 Difficulty breathing44 Convulsions4 Sensitization4 Death20 26

27. Component Risk Assessment Chronic Health Effects Cancer10 Teratogenesis10 Mutagenesis10 Exposure limits (PEL and TLV) >1,000 ppm0 100-1,000 ppm2 10-100 ppm5 1-10 ppm3 ppm TWA, 6 ppm STEL10 <1 ppm20 Total Risks:42 27

28. Component Risk Assessment Probability of Exposure Indicators: Routes of Exposure Ingestion1 Ingestion + Inhalation3 Ingestion + Inhalation + Skin Contact66 Physical Form Solids, pellets0 Liquids, granules11 Mists2 Vapors, fumes3 28

29. Component Risk Assessment Boiling Point >400C0 300-400C1 200-299C5 100-199C170 C10 0-99C15 <0C20 29

30. Component Risk Assessment Vapor Pressure (mm Hg @ 20C) <10.4 mm00 1-102 11-10010 101-76020 Vapor Hazard Ratio [(Vpress)(10E6)/760]/TLV or PEL (Arizona State Un.) <100 10-1,00022 1,000-10,0005 10,000-100,00010 >100,00020 Total Probability of Exposure:19 GCA Material Rating 105 30

31. Exposure Risk Determination Exposure Risk: Components in 1 ml of concentrated cleaner:Benzyl Alcohol - 269 ppmEthanolamine - 75 ppm Dilution to working strength:1 parts cleaner diluted with 4 parts water to 20% concentration Components in 1 ml of diluted cleaner:Benzyl Alcohol - 54 ppmEthanolamine - 15 ppm Typical usage: 500 mls in 15 minutes (33.3 mls/min.) Potential Exposure:1,800 ppm/min.500 ppm/min. Permitted Exposure Level:10 ppm3 ppm TWA/6 ppm STEL Exposure Assessment:Expected: 2 Hour* usage>>> PELTarget: 2 Hour usage < PEL 31

32. Cost Assessment Cost Assessment: Container size:2 Liters Price per container:$25.00 Dilution:Dilute 1:5 Cost/Working Gallon:$9.47 32

33. ATP Bioluminescence Test Method 33

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 34 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 35

36. Reaction for Light Measurement Luciferin + Luciferase + ATP + Mg ++ -> (Luciferin-Luciferase-AMP) + Pyrophosphate (Luciferin-Luciferase-AMP) + O 2 -> Oxyluciferin + Luciferase + CO2 + AMP + Light 36

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”. 37

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 38

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 39

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 40

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. 41

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 42

43. Features/Benefits of New Portable Cleaning Test System FeaturesBenefits Consistent, measureable resultsReliable results to confirm cleaning effectiveness Real time proactive solutionsTo implement immediate corrective actions and assure surfaces are clean Ease of use (swabs)Reduces variability between users Ease of use (instrument)Reduces errors, training time and costs Data managementTrack results of cleaning effectiveness over time with statistical control 43

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 44

45. “Infection Control QA in the Patient Care Environment using ATP Bioluminescent Technology” Mark Gallivan, Un of Minnesota Sampling610 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 Surfaces5 Different Surfaces Bedrail Keyboard Treatment cart Bathroom door knob Toilet flush handle 45

46. “Infection Control QA in the Patient Care Environment using ATP Bioluminescent Technology” Mark Gallivan, Un of Minnesota Mean RLU ValuesMedian RLU ValuesRange RLU Values SurfacesOccupiedDischargedOccupiedDischargedOccupiedDischarged Bedrail1287458363142(37-26,825)(57-6,891) Keyboard22323811171(15-6,911)(15-5,642) Treatment Cart399309129104(20-4,571)(20-4,280) Door Knob608445379282(56-6,640)(25-2,949) Toilet Flush Handle422856194126(14-3,458)(21-27,896) 46

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 47

48. U.S. EPA Actions 48

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 49

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? 50

51. How AD Ensures Product Efficacy for Hospital Disinfectants Product Performance Laboratory studies are submitted by the registrants to demonstrate that their product will perform against target pests (microorganisms) when the product is used according to label directions Studies are conducted using standardized tests, usually from the AOAC International Hospital disinfectants must demonstrate effectiveness against: Staphylococcus aureus Salmonella enterica Pseudomonas aeruginosa Using: AOAC Use-dilution Test Germicidal Spray Products Test or EPA Towlette Test 51

52. Overview of the AD Testing Program 52

53. Antimicrobial Testing Program Web Page Now Available Current as of June 12, 2009 Program overview Testing results What if a product fails? Product universe Collection of products How tests are performed Next steps 53

54. Program Overview Antimicrobial Testing Program (ATP) started testing hospital sterilants, disinfectants and tuberculosides in 1991 EPA collects samples from manufacturers or other places Test methods are rigorous challenge with bacteria levels at least 1,000 times greater than typical contamination levels found in healthcare facilities Current focus is on “primary” registration of each product formulation 54

55. Program Overview Manufacturers often contract with distributors, who then register products with identical formulas Current results: About two-thirds of hospital disinfectants and one-half of tuberculocides are fully efficacious when challenged at the highest bacteria challenge level Those that do not meet this high standard are brought into compliance through regulatory or enforcement measures, or a combination of both. Continuing efforts to complete testing the initial group of products and developing long term strategy for continued oversight of both the primary products and the larger group of distributor products 55

56. Testing Results Products tested through the ATP (pdf available) 325 hospital disinfectants (~218 met standards) 72 tuberculocides (~36 met standards) Tuberculocides must be effective also against mocobacterium bovis BCG 56

57. What If a Product Fails? EPA will determine the appropriate action: Product reformulation and retest by mfgr Removal of Hospital Disinf or TB claims from label Modification of label directions, i.e., contact times, and retesting by the mfgr following new directions Voluntary cancellation of product by mfgr EPA initiates removal of product from market place (e.g. stop sale orders) 57

58. Product Universe 1991 ATP initiated Tuberculocides Hospital disinfectants Sterilants 1993 Sterilant testing completed 1996 Regulatory authority for certain liquid chemical sterilant products transferred to FDA under Food Quality Protection Act amendments to FIFRA. 58

59. Collection of Products In the past: Collection by official federal or state inspectors Present: Collection Internet purchases Direct shipment from registrant Purchase from marketplace December 2008 EPA letter to primary registrants requesting samples be sent directly to their laboratories for testing. This form of sampling only for completion of initial testing EPA expects to return to random testing of products after initial testing is complete 59

60. How Tests are Performed Product registration & post-registration Specific methods for testing effectiveness maintained and published by Association of Analytical Chemists (AOAC) International Challenge microorganisms: Staphylococcus aureus, Pseudomonas aeruginosa, and Mycobacterium bovis BCG Four laboratories do testing: Ohio Department of Agriculture/Consumer Analytical Laboratory North Carolina Department of Agriculture and Consumer Services Michigan Department of Agriculture/Laboratory Division EPA’s Office of Pesticide Program’s Microbiology Laboratory Branch 60

61. EPA’s Standard Operating Procedures for ATP Testing MB-02-03 Culture initiation, maintenance and Quality Control MB-02-04 Tracking of test microorganisms MB-03-04 Screening carriers used in disinfectant efficacy testing MB-04-05 Enumeration of bacterial inocula on carriers MB-05-06 AOAC Use dilution Method for testing disinfectants 61

62. EPA’s Standard Operating Procedures for ATP Testing MB-06-03 Germicidal Spray Products as Disinfectants: MB-07-04 Tuberculocidal Activity of Disinfectants: II. Confirmative in vitro Test for determining tuberculocidal activity MB-09-02 Disinfectant Towlette Test against Staphylococcus aureus and Pseudomonas aeruginosa MB-11-02 Neutralization Confirmation Assay for Disinfectant Products Tested against Mycobacterium bovis (BCG) MB-22-00 Disinfectant sample preparation 62

63. List of Products Tested or Pending Definitions Claims Tested: Hospital Disinfectant (HD) and or Tuberculocide (TB) Claims in Compliance: Label claim is in compliance with EPA Standards. NA indicates claim confirmation not applicable Product Voluntarily Cancelled: Product was voluntarily canceled by the registrant Claim Removed: Pathogen claim removed from product labeling Under Agency Review: Products tested, Agency action pending Voluntarily Submitted to EPA for Testing: Sample submitted by mfgr in response to EPA letter of request dated December 19, 2008 RTC: Retest claim due to issues with initial testing 63

64. Table Format (pdf) Sample Number: Registration Number: Registrant: Product Name: Claims Tested (HD) (TB): Yes or No Claims in Compliance (HD) (TB): Yes, NA, RTC Product Voluntarily Canceled: Yes, Blank Claim Removed: Blank, Removed hospital site, TB claim removed, HD/TB claims removed Under Agency Review: Blank, HD claims under Agency review, HD and TB under Agency review, TB under Agency review Voluntarily Submitted to EPA For Testing: Yes, Blank 64

65. Familiar Company Names 3M AIRKEM Professional Products Clorox Company ECOLAB JohnsonDiversey Spartan Chemical Company 65

66. 3M NumberProduct NameStatus 328HB Quat Disinfectant Cleaner Concentrate Voluntarily Submitted 66

67. AIRKEM Professional Products #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 275A-33Yes/No0/NAHD under Agency Review 276OmegaYes/No0/NAHD under Agency Review 277AsepticareVoluntarily Submitted 278A-33 DryYes/No0/NAHD Under Agency Review 279A-456-NYes/NoYes/NA 280A-464-NYes/NoYes/NAProduct Voluntarily Canceled 67

68. Clorox Company #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 170Clean-UpYes/NoYes/NA 171Disinfecting Bathroom Cleaner Vol. Sub. 172Ultra CloroxYes/Yes 173Spruce-UpsYes/No0/NAAgency Review 344Disinfecting SprayVol. Sub. 345CPPC EverestYes/NoYes/NA 346Germicidal WipesVol. Sub. 347Germicidal SprayVol. Sub. 68

69. ECOLAB #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 86MIKRO-QUATYes/NoYes/NA 87MikrokleneYes/NoYes/NA 88D-QUAT IIYes/NoYes/NA 89Oxonia ActiveYes/YesYes/0TB Claim Removed 90Quorum CleanerYes/NoYes/NA 91VortexxYes/NoYes/NA 92Multi-QuatYes/NoYes/NA 69

70. ECOLAB (cont.) #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 9365 Disinf. HD Acid Bathroom Cleaner Yes/NoYes/NA 94Octave FSVol. Sub. 95Exspor Base Conc.Vol. Sub. 131ENVERROS Sanimaster 4 Yes/NoYes/NA 287Exspor Base Conc.Yes/Yes 288LD Base Conc.Yes/NoYes/NA 70

71. JohnsonDiversey #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 49Quat 256Yes/NoYes/NARemoved Hospital Site 187CREW NA Bathroom ClVol. Sub. 361Disinf. DC100Vol. Sub. 362Phenolic Disin. HGVol. Sub. 363Blue Chip Germicide Cleaner for Hospitals Vol. Sub. 365Envy Liq. Dis. Cl.Vol. Sub. 366ALPHA HPVol. Sub. 367OXIVIR TBVol. Sub. 368Carpe Diem Conc. Five 16Vol. Sub. 71

72. Spartan Chemical Co. #Product NameClaims Tested HD/TB Claims in Compliance HD/TB Status 160STERIGENTYes/NoYes/NA 161PD-64 Phenolic Base Cl&DisYes/Yes 162METAQUAT Germ. CLEYes/NoYes/NA 163SANI-T-10Yes/NoYes/NA 164TNT Tub & Tile CleanerYes/NoYes/NA 165DMQYes/NoYes/NA 166CDC-10Yes/NoYes/NA 167STERIPHENE II Deod.Yes/Yes 168FOAMY Q&AYes/NoYes/NA 169Green Sol. Rroom CleanserYes/NoVol. Sub. 72

73. Next Steps Goal is set for completion of post-registration evaluation of efficacy by end of 2011 EPA developing an ATP Strategy to include continued oversight of “primary” and “distributor” products Strategy and implementation plan scheduled for completion early 2010 and will be publicly available 73

74. EPA Reaches Settlement Release date: July 31, 2009 Region 2 (NY) Contact Information: Sophia Kelly (212) 637-3670, kelley.jessicasophia@epa.gov kelley.jessicasophia@epa.gov Third pesticide enforcement case settled against Lonza Inc., the nation’s largest manufacturer of hospital disinfectants, for multiple violations of the federal law that regulates pesticides. Agreed to pay fines for allegedly making misleading claims regarding the efficacy of two products. Settlement (>$640,000.00) is one of the largest civil penalties under FIFRA. Company previously agreed to develop a supplemental ground-breaking environmental project, valued at $390,000.00. 74

75. EPA Reaches Settlement George Pavlou, acting EPA Regional Admin. said “It may surprise people to know that part of EPA’s job is to make sure disinfectants are as effective as they claim, and we take this job very seriously.” “Products that make claims that are not met put people at risk of getting sick. We are pleased that Lonza has agreed to not only pay penalties but to take steps that will go a long way toward rectifying the problem.” 75

76. EPA Reaches Settlement Products cited for inefficacy Saniphor No. 450, registered as Tuberculocide, but found ineffective against a bacteria causing Tuberculosis 7 Healthcare Disinfectant Neutral Cleaner, did not kill the pathogen Pseudomonas aeruginosa, as claimed on the label Klear Guard Tub & Tile Foaming Germicidal Cleaner, cited as misbranded for use of label with missing first aid information 76

77. EPA Reaches Settlement Lonza has already begun its project to institute rigorous quality assurance and product efficacy testing at more than 470 formulators of Lonza products nationwide. This will help ensure that the products sold are effective and provide public health protection. 77

78. Feedback to EPA’s Healthcare Outreach Launch? 1. 78

79. Questions??? 79 Thank You!!!