Transcript Slide 1

NHICEP Conference
NH Hospital Association
September 15, 2009
Cleaning Chemicals: Risk, Cleanliness
Testing and EPA Regulatory Update
Jack Fellman
Greener Chemistry Associates LLC
1
Topics for Discussion
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Chemical Risk Assessment Model
ATP Bioluminescence Test Method
U.S. EPA Actions
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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
Chemical Risk Assessment
Model
3
GCA Cleaning Product Risk
Assessment Considerations
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Health
Environment
Potential For Exposure of Personnel
Storage & Handling
Product Cost/Working Gallon
Product Performance
4
GCA Cleaning Product Risk
Assessment Objectives
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Reduce Health and Environmental risks
Reduce potential personnel exposure
Product upgrade should be cost neutral
Increase usage of 3rd party certified products or
better
5
What is a GCA Chemical Risk
Assessment?
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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
Criteria for GCA Risk
Assessments
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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.
2.
3.
4.
5.
6.
Product is identified with 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
calculate and compare the estimated exposure to
documented exposure limits (OSHA)
Product cost and typical dilutions used to calculate
cost/working gallon
8
Product is Selected
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Product name
MSDS number
Product codes
Recommended use
Manufacturer
Concentrate or Ready to Use
Dilution Ratio
Estimated Usage per Hour
9
Hazardous Ingredients are
Identified
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Chemical name(s)
CAS Number(s)
% Weight Concentration
10
Component Risk Assessments
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Hazards
 Health
 Physical
Degree of Hazard
 Flash point
 Toxicity
 Aquatic Toxicity
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Risks
 Acute health effects
 Chronic health
effects
 Exposure limits
Exposure indicators
 Routes of exposure
 Physical form
 Vapor hazard ratio
11
Product Risk Assessment

Example
12
Product Information
Product Name: ABC
MSDS #:
Number
Product Code:
123456
Cleaning
Product
7/10/2009
Use:
Concentrate or
RTU:
Concentrate
Manufacturer: DEF
13
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
56
42
14
19
89
105
GCA Risks
GCA Probability of
Exposure
GCA Product Risk
Assessment
194.0
14
Component Risk Assessment
Chemical
Name:
Hazards:
Ethanolamine
(2-aminoethanol)
141CAS # 43-5
Potential Actual
7/10/2009
Health Hazards
Carcinogen
10
Corrosive
2
2
Irritant
2
2
Sensitizer
4
Toxic
2
Highly Toxic
4
4
15
Component Risk Assessment
Target Organ Effect
Liver
3
3
Kidney
3
3
Lymphoid system
3
Central nervous system
3
Blood forming organs
3
Respiratory tract
3
3
Lungs
3
3
3
16
Component Risk Assessment
Reproductive toxin
Teratogen
4
Mutagen
4
Skin
3
3
Eyes
4
4
Total Health Hazards
30
17
Component Risk Assessment
Physical Hazards
Combustible Liquid
2
Flammable
3
Oxidizer
4
Total Physical Hazards:
2
2
18
Component Risk Assessment
Degree of Hazard:
Flash Point (oF)
>200
0
150-200
1
100-150
2
1-100
3
<0
4
1
19
Component Risk Assessment
Oral, rat LD50 (mg/kgbw)
>15,000
0
5,000-15,000
1
500-5,000
1,720
2
50-500
3
1.0-50
4
<1
5
2
20
Component Risk Assessment
Inhalation, mouse LC50 (ppm)
>100,000
0
10,000-100,000
1
1,000-10,000
2,420
2
100-1,000
3
10-100
4
<10
5
2
21
Component Risk Assessment
Skin, rabbit LD50 (mg/kg)
>22,600
0
2,820-22,590
1
350-2,810
1,000
2
44-340
3
5.0-43
4
<5
5
2
22
Component Risk Assessment
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
<1 or >14
4
3
23
Component Risk Assessment
Aquatic Toxicity-Acute (L/E/IC50)
>100 ppm
0
10-100 ppm
1
1-10 ppm
2
<1 ppm
3
0
Biological Half-life
minutes
0
hours
1
days
2
weeks
3
years
4
Total Degree of Hazards:
2
12
24
Component Risk Assessment
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
25
Component Risk Assessment
Nausea
3
3
Vomiting
3
3
Diarrhea
3
Headache
2
Dizziness
2
Narcotic effect
3
3
Difficulty breathing
4
4
Convulsions
4
Sensitization
4
Death
2
20
26
Component Risk Assessment
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
<1 ppm
Total Risks:
3 ppm TWA, 6 ppm STEL
10
10
20
42
27
Component Risk Assessment
Probability of Exposure Indicators:
Routes of Exposure
Ingestion
1
Ingestion + Inhalation
3
Ingestion + Inhalation + Skin Contact
6
Solids, pellets
0
Liquids, granules
1
Mists
2
Vapors, fumes
3
6
Physical Form
1
28
Component Risk Assessment
Boiling Point
>400C
0
300-400C
1
200-299C
5
100-199C
170 C
10
0-99C
15
<0C
20
10
29
Component Risk Assessment
Vapor Pressure (mm Hg @ 20C)
<1
0.4 mm
1-10
0
0
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
1,000-10,000
5
10,000-100,000
10
>100,000
20
Total Probability of Exposure:
GCA Material Rating
2
19
105
30
Exposure Risk Determination
Exposure Risk:
Components in 1
ml of concentrated
cleaner:
Benzyl Alcohol - 269 ppm
Ethanolamine - 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 ppm
Ethanolamine - 15 ppm
500 mls in 15 minutes (33.3
Typical usage:
mls/min.)
Potential
Exposure:
1,800 ppm/min.
500 ppm/min.
Permitted
Exposure Level:
10 ppm
3 ppm TWA/6 ppm STEL
Exposure
Assessment:
Expected: 2 Hour* usage>>> PEL Target: 2 Hour usage < PEL
31
Cost Assessment
Cost Assessment:
Container size:
Price per
container:
2 Liters
Dilution:
Cost/Working
Gallon:
Dilute 1:5
$25.00
$9.47
32
ATP Bioluminescence Test Method
33
How Clean Is It?
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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
What is ATP and how do we
measure it?
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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
Reaction for Light Measurement
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Luciferin + Luciferase + ATP + Mg++ ->
(Luciferin-Luciferase-AMP) + Pyrophosphate

(Luciferin-Luciferase-AMP) + O2 ->
Oxyluciferin + Luciferase + CO2 + AMP +
Light
36
New Portable Cleaning Test
System
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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
How does it work?
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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
How long can contaminated
swabs be held before analysis?
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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
Is monitoring hospital cleaning practices with New
Portable Cleaning Test system “effective”?
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Study by Boyce, et. al., Hospital of Saint
Raphael and Yale University School of Medicine
Conclusions:
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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
How does the New Portable Cleaning Test System
compare to other methods for “sensitivity”?
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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:
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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
How does the New Portable cleaning Test System
compare to other systems for “repeatability”?
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Independent study by Simpson and Giles, Cara
Technology, Ltd (2006), “The repeatability of hygiene
test systems in measurement of low levels of ATP”.
Conclusions
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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
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
43
Field Experience with the New
ATP Test System
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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
“Infection Control QA in the Patient Care
Environment using ATP Bioluminescent
Technology” Mark Gallivan, Un of Minnesota
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Sampling
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To compare the RLUs of occupied vs discharged patient rooms
Location
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4 Different Wards
Bone marrow transplant
Neurology
Solid organ transplant
Medical intensive care
Surfaces
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610 Samples
5 Different Surfaces
Bedrail
Keyboard
Treatment cart
Bathroom door knob
Toilet flush handle
45
“Infection Control QA in the Patient Care
Environment using ATP Bioluminescent
Technology” Mark Gallivan, Un of Minnesota
Mean RLU Values
Surfaces
Bedrail
Occupied
Median RLU Values
Discharged Occupied
Range RLU Values
Discharged Occupied
Discharged
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)
46
“Infection Control QA in the Patient Care
Environment using ATP Bioluminescent
Technology” Mark Gallivan, Un of Minnesota
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Sensitivity
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High Variability
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Capable of achieving p < 0.05 results
Comparability of Surfaces
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Data skewed to the right from high outliers
Real Time Monitoring of Protocol
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Capable of detecting clean and unclean surfaces
Not valid due to surface area and type
Creation of Baseline RLU Values

Should be created for individual surfaces
47
U.S. EPA Actions
48
Antimicrobial Labeling Update
From U.S. EPA
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July 30, 2009
Presented by:
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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
Presentation Overview
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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
How AD Ensures Product Efficacy for
Hospital Disinfectants
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Product Performance
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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:
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Staphylococcus aureus
Salmonella enterica
Pseudomonas aeruginosa
Using:
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AOAC Use-dilution Test
Germicidal Spray Products Test or
EPA Towlette Test
51
Overview of the AD Testing
Program
52
Antimicrobial Testing Program
Web Page Now Available

Current as of June 12, 2009
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Program overview
Testing results
What if a product fails?
Product universe
Collection of products
How tests are performed
Next steps
53
Program Overview
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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
Program Overview
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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
Testing Results

Products tested through the ATP (pdf
available)
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325 hospital disinfectants (~218 met standards)
72 tuberculocides (~36 met standards)
Tuberculocides must be effective also against
mocobacterium bovis BCG
56
What If a Product Fails?

EPA will determine the appropriate action:
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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
Product Universe

1991 ATP initiated
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1993
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Tuberculocides
Hospital disinfectants
Sterilants
Sterilant testing completed
1996
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Regulatory authority for certain liquid chemical
sterilant products transferred to FDA under Food
Quality Protection Act amendments to FIFRA.
58
Collection of Products

In the past:
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
Collection by official federal or state inspectors
Present:

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Collection
Internet purchases
Direct shipment from registrant
Purchase from marketplace
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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
How Tests are Performed

Product registration & post-registration
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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:
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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
EPA’s Standard Operating
Procedures for ATP Testing

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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
EPA’s Standard Operating
Procedures for ATP Testing
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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
List of Products Tested or
Pending

Definitions

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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
Table Format (pdf)

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
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
Familiar Company Names

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

3M
AIRKEM Professional Products
Clorox Company
ECOLAB
JohnsonDiversey
Spartan Chemical Company
65
3M
Number
Product Name
Status
328
HB Quat Disinfectant
Cleaner Concentrate
Voluntarily Submitted
66
AIRKEM Professional Products
#
Product Name Claims Tested Claims in
Status
HD/TB
Compliance
HD/TB
275
A-33
Yes/No
0/NA
HD under Agency
Review
276
Omega
Yes/No
0/NA
HD under Agency
Review
277
Asepticare
278
A-33 Dry
Yes/No
0/NA
279
A-456-N
Yes/No
Yes/NA
280
A-464-N
Yes/No
Yes/NA
Voluntarily Submitted
HD Under Agency
Review
Product Voluntarily
Canceled
67
Clorox Company
#
Product Name
Claims
Tested
HD/TB
Claims in
Status
Compliance
HD/TB
170
Clean-Up
Yes/No
Yes/NA
171
Disinfecting
Bathroom Cleaner
172
Ultra Clorox
Yes/Yes
Yes/Yes
173
Spruce-Ups
Yes/No
0/NA
344
Disinfecting Spray
345
CPPC Everest
346
Germicidal Wipes
Vol. Sub.
347
Germicidal Spray
Vol. Sub.
Vol. Sub.
Agency Review
Vol. Sub.
Yes/No
Yes/NA
68
ECOLAB
#
Product Name
Claims Tested
HD/TB
Claims in
Status
Compliance
HD/TB
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
90
Quorum Cleaner Yes/No
Yes/NA
91
Vortexx
Yes/No
Yes/NA
92
Multi-Quat
Yes/No
Yes/NA
TB Claim Removed
69
ECOLAB (cont.)
#
Product Name
Claims
Tested
HD/TB
Claims in
Compliance
HD/TB
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
70
JohnsonDiversey
#
Product Name
Claims
Tested
HD/TB
Claims in
Status
Compliance
HD/TB
49
Quat 256
Yes/No
Yes/NA
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.
Removed Hospital
Site
71
Spartan Chemical Co.
#
Product Name
Claims
Tested
HD/TB
Claims in
Compliance
HD/TB
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
Status
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
73
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.
74
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
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
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
Feedback to EPA’s Healthcare
Outreach Launch?

1.
78
Questions???
Thank You!!!
79