1 NHICEP Conference NH Hospital Association September 15, 2009 Cleaning Chemicals: Risk, Cleanliness Testing and EPA Regulatory Update Jack Fellman Greener

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NHICEP ConferenceNH Hospital Association

September 15, 2009

Cleaning Chemicals: Risk, Cleanliness Testing and EPA Regulatory Update

Jack Fellman

Greener Chemistry Associates LLC

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

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Chemical Risk Assessment Model

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GCA Cleaning Product Risk Assessment Considerations

Health Environment Potential For Exposure of Personnel Storage & Handling Product Cost/Working Gallon Product Performance

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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

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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

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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

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

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Product is Selected

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

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Hazardous Ingredients are Identified

Chemical name(s) CAS Number(s) % Weight Concentration

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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

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Product Risk Assessment

Example

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Product Information

Product Name: ABC 7/10/2009

MSDS #: Number

Product Code: 123456

Use:Cleaning Product

Concentrate or RTU: Concentrate

Manufacturer: DEF

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Hazardous Components & Summary of GCA Component Assessment

Component: 1 2Total

Ingredient: Benzyl Alcohol Ethanolamine

CAS #: 100-51-6 141-43-5

Max in Product: 25% 7%

GCA Health Hazard 8 30

GCA Physical Hazard 2 2

GCA Degree of Hazard 9 12

GCA Risks 56 42GCA Probability of Exposure 14 19

89 105GCA Product Risk Assessment 194.0

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Component Risk Assessment

Chemical Name:

Ethanolamine (2-aminoethanol) CAS #

141-43-5

Hazards: Potential Actual 7/10/2009

Health Hazards

Carcinogen 10

Corrosive 2 2

Irritant 2 2

Sensitizer 4

Toxic 2

Highly Toxic 4 4

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Target Organ Effect

Liver 3 3

Kidney 3 3

Lymphoid system 3

Central nervous system 3 3

Blood forming organs 3

Respiratory tract 3 3

Lungs 3 3

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Reproductive toxin

Teratogen 4

Mutagen 4

Skin 3 3

Eyes 4 4

Total Health Hazards 30

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Physical Hazards

Combustible Liquid 2 2

Flammable 3

Oxidizer 4

Total Physical Hazards: 2

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Degree of Hazard:

Flash Point (oF)

>200 0

150-200 1 1

100-150 2

1-100 3

<0 4

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Oral, rat LD50 (mg/kgbw)

>15,000 0

5,000-15,000 1

500-5,000 1,720 2 2

50-500 3

1.0-50 4

<1 5

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Inhalation, mouse LC50 (ppm)

>100,000 0

10,000-100,000 1

1,000-10,000 2,420 2 2

100-1,000 3

10-100 4

<10 5

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Skin, rabbit LD50 (mg/kg)

>22,600 0

2,820-22,590 1

350-2,810 1,000 2 2

44-340 3

5.0-43 4

<5 5

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Corrosivity (pH)

6.0-9.0 0

5-6 or 9-10 1

3-5 or 10-12 2

1-3 or 12-14 3 3

<1 or >14 4

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Aquatic Toxicity-Acute (L/E/IC50)

>100 ppm 0 0

10-100 ppm 1

1-10 ppm 2

<1 ppm 3

Biological Half-life

minutes 0

hours 1

days 2 2

weeks 3

years 4

Total Degree of Hazards: 1224


Risks:

Acute Health Effects

Irritation 1 1

Sore throat 2 2

Coughing 2 2

Redness 2 2

Burning 4 4

Pain 4 4

Tearing 2 2

Stinging 2

Swelling 2

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Nausea 3 3

Vomiting 3 3

Diarrhea 3

Headache 2 2

Dizziness 2

Narcotic effect 3 3

Difficulty breathing 4 4

Convulsions 4

Sensitization 4

Death 20

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Chronic Health Effects

Cancer 10

Teratogenesis 10

Mutagenesis 10

Exposure limits (PEL and TLV)

>1,000 ppm 0

100-1,000 ppm 2

10-100 ppm 5

1-10 ppm 3 ppm TWA, 6 ppm STEL 10 10

<1 ppm 20

Total Risks: 42

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Probability of Exposure Indicators:Routes of Exposure

Ingestion 1

Ingestion + Inhalation 3

Ingestion + Inhalation + Skin Contact 6 6

Physical Form

Solids, pellets 0

Liquids, granules 1 1

Mists 2

Vapors, fumes 3

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Boiling Point

>400C 0

300-400C 1

200-299C 5

100-199C 170 C 10 10

0-99C 15

<0C 20

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Vapor Pressure (mm Hg @ 20C)

<1 0.4 mm 0 0

1-10 2

11-100 10

101-760 20

Vapor Hazard Ratio [(Vpress)(10E6)/760]/TLV or PEL (Arizona State Un.)

<10 0

10-1,000 2 2

1,000-10,000 5

10,000-100,000 10

>100,000 20

Total Probability of Exposure: 19

GCA Material Rating 105 30

Exposure Risk Determination

Exposure Risk: Components in 1 ml of concentrated cleaner: Benzyl Alcohol - 269 ppm Ethanolamine - 75 ppmDilution to working strength: 1 parts cleaner diluted with 4 parts water to 20% concentrationComponents in 1 ml of diluted cleaner: Benzyl Alcohol - 54 ppm Ethanolamine - 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 ppm 3 ppm TWA/6 ppm STELExposure Assessment: Expected: 2 Hour* usage>>> PEL Target: 2 Hour usage < PEL

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Cost Assessment

Cost Assessment:

Container size: 2 LitersPrice per container: $25.00

Dilution: Dilute 1:5Cost/Working Gallon: $9.47

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ATP Bioluminescence Test Method

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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

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C. Ramsay, Biotrace International July 29, 2003

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

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Reaction for Light Measurement

Luciferin + Luciferase + ATP + Mg++ ->

(Luciferin-Luciferase-AMP) + Pyrophosphate

(Luciferin-Luciferase-AMP) + O2 ->

Oxyluciferin + Luciferase + CO2 + AMP + Light

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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”.

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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 seconds38

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

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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

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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.

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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

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Features/Benefits of New Portable Cleaning Test System

Features Benefits

Consistent, measureable results Reliable results to confirm cleaning effectiveness

Real time proactive solutions To 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 management Track results of cleaning effectiveness over time with statistical control

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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

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“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

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Mean RLU Values Median RLU Values Range RLU Values

Surfaces Occupied Discharged Occupied Discharged Occupied Discharged

Bedrail 1287 458 363 142(37-26,825) (57-6,891)

Keyboard 223 238 111 71(15-6,911) (15-5,642)

Treatment Cart 399 309 129 104(20-4,571) (20-4,280)

Door Knob 608 445 379 282(56-6,640) (25-2,949)

Toilet Flush Handle 422 856 194 126(14-3,458) (21-27,896)

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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

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U.S. EPA Actions

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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

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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?

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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

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Overview of the AD Testing Program

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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

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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

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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

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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

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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)

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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.

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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

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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

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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

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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

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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 testing63

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

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Familiar Company Names

3M AIRKEM Professional Products Clorox Company ECOLAB JohnsonDiversey Spartan Chemical Company

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3M

Number Product Name Status

328 HB Quat Disinfectant Cleaner Concentrate

Voluntarily Submitted

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AIRKEM Professional Products

# Product Name Claims TestedHD/TB

Claims in ComplianceHD/TB

Status

275 A-33 Yes/No 0/NA HD under Agency Review

276 Omega Yes/No 0/NA HD under Agency Review

277 Asepticare Voluntarily Submitted

278 A-33 Dry Yes/No 0/NA HD Under Agency Review

279 A-456-N Yes/No Yes/NA

280 A-464-N Yes/No Yes/NA Product Voluntarily Canceled

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Clorox Company



Status

170 Clean-Up Yes/No Yes/NA

171 Disinfecting Bathroom Cleaner

Vol. Sub.

172 Ultra Clorox Yes/Yes Yes/Yes

173 Spruce-Ups Yes/No 0/NA Agency Review

344 Disinfecting Spray Vol. Sub.

345 CPPC Everest Yes/No Yes/NA

346 Germicidal Wipes Vol. Sub.

347 Germicidal Spray Vol. Sub.

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ECOLAB



Status

86 MIKRO-QUAT Yes/No Yes/NA

87 Mikroklene Yes/No Yes/NA

88 D-QUAT II Yes/No Yes/NA

89 Oxonia Active Yes/Yes Yes/0 TB Claim Removed

90 Quorum Cleaner Yes/No Yes/NA

91 Vortexx Yes/No Yes/NA

92 Multi-Quat Yes/No Yes/NA

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ECOLAB (cont.)



Status

93 65 Disinf. HD Acid Bathroom Cleaner

Yes/No Yes/NA

94 Octave FS Vol. Sub.

95 Exspor Base Conc. Vol. Sub.

131 ENVERROS Sanimaster 4

Yes/No Yes/NA

287 Exspor Base Conc. Yes/Yes Yes/Yes

288 LD Base Conc. Yes/No Yes/NA

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JohnsonDiversey



Status

49 Quat 256 Yes/No Yes/NA Removed Hospital Site

187 CREW NA Bathroom Cl Vol. Sub.

361 Disinf. DC100 Vol. Sub.

362 Phenolic Disin. HG Vol. Sub.

363 Blue Chip Germicide Cleaner for Hospitals

Vol. Sub.

365 Envy Liq. Dis. Cl. Vol. Sub.

366 ALPHA HP Vol. Sub.

367 OXIVIR TB Vol. Sub.

368 Carpe Diem Conc. Five 16 Vol. Sub. 71

Spartan Chemical Co.



Status

160 STERIGENT Yes/No Yes/NA

161 PD-64 Phenolic Base Cl&Dis Yes/Yes Yes/Yes

162 METAQUAT Germ. CLE Yes/No Yes/NA

163 SANI-T-10 Yes/No Yes/NA

164 TNT Tub & Tile Cleaner Yes/No Yes/NA

165 DMQ Yes/No Yes/NA

166 CDC-10 Yes/No Yes/NA

167 STERIPHENE II Deod. Yes/Yes Yes/Yes

168 FOAMY Q&A Yes/No Yes/NA

169 Green Sol. Rroom Cleanser Yes/No Vol. Sub.72

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

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EPA Reaches Settlement Release date: July 31, 2009 Region 2 (NY) Contact Information: Sophia Kelly (212) 637-3670,

[email protected] 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.

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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.”

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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

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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.

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Feedback to EPA’s Healthcare Outreach Launch?

1.

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Questions???

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Thank You!!!

Documents

1 NHICEP Conference NH Hospital Association September 15, 2009 Cleaning Chemicals: Risk, Cleanliness Testing and EPA Regulatory Update Jack Fellman Greener