Chemical Risk Assessment Form by eiz16600

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									              NH3E
          NH Hospitals
   for a Healthy Environment
         September 10, 2009




Cleaning Chemicals: Risk, Cleanliness
  Testing and EPA Regulatory Update
                        Jack Fellman
         Greener Chemistry Associates LLC
66 Ridgeview Lane, New Boston, NH 03070
                     Office: 603-487-2235
   <Jfellman@GreenerChemistryLLC.com>       1
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
Chemical Risk Assessment
Model




                           3
GCA Cleaning Product Risk
Assessment Considerations
   Health
   Environment
   Potential For Exposure of Personnel
   Storage & Handling
   Product Cost/Working Gallon
   Product Performance



                                          4
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




                                                        5
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
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
                                                                 8
Product is Selected
   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
   Chemical name(s)
   CAS Number(s)
   % Weight Concentration




                             10
Component Risk Assessments
   Hazards                 Risks
     Health                  Acute health effects

     Physical                Chronic health

   Degree of Hazard           effects
     Flash point             Exposure limits

     Toxicity              Exposure indicators
     Aquatic Toxicity        Routes of exposure

                              Physical form

                              Vapor hazard ratio
                                                  11
Product Risk Assessment
   Example




                          12
Product Information

Product Name: ABC                7/10/2009

MSDS #:         Number

Product Code:           123456
                Cleaning
Use:            Product
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
GCA Risks                                56                  42
GCA Probability of
Exposure                                 14                  19
                                         89                  105
GCA Product Risk
Assessment                                                         194.0
                                                                           14
 Component Risk Assessment
Chemical         Ethanolamine                              141-
Name:            (2-aminoethanol)                    CAS # 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




                                                                  15
Component Risk Assessment
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




                                              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    2
Flammable                 3
Oxidizer                  4
Total Physical Hazards:        2




                              18
 Component Risk Assessment
Degree of Hazard:
Flash Point (oF)
                   >200      0
                   150-200   1    1
                   100-150   2
                   1-100     3
                   <0        4




                                 19
Component Risk Assessment
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




                                            20
Component Risk Assessment
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




                                               21
 Component Risk Assessment
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




                                             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   3
              <1 or >14      4




                                     23
 Component Risk Assessment
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:                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    2
Dizziness              2
Narcotic effect        3    3
Difficulty breathing   4    4
Convulsions            4
Sensitization          4
Death                  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                   3 ppm TWA, 6 ppm STEL   10   10
<1 ppm                                             20
Total Risks:                                            42


                                                             27
Component Risk Assessment
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




                                                                28
 Component Risk Assessment
Boiling Point
>400C                   0
300-400C                1
200-299C                5
100-199C        170 C   10   10
0-99C                   15
<0C                     20




                                  29
Component Risk Assessment
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 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

Typical usage:     500 mls in 15 minutes
Permitted
Exposure Level:    10 ppm                              3 ppm TWA/6 ppm STEL
Potential
Exposure:          1,800 ppm/min.                      500 ppm/min.
Exposure
Assessment:        Expected: 2 Hour* usage>>> PEL      Target: 2 Hour usage < PEL
                                                                                      31
 Cost Assessment
Cost Assessment:




Container size:    2 Liters
Price per
container:                      $25.00

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




                                         32
ATP Bioluminescence Test Method




                                  33
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
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
Reaction for Light Measurement
   Luciferin + Luciferase + ATP + Mg++ ->
    (Luciferin-Luciferase-AMP) + Pyrophosphate

   (Luciferin-Luciferase-AMP) + O2 ->
    Oxyluciferin + Luciferase + CO2 + AMP +
    Light



                                                 36
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
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
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
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
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
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
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
   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

   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
                                                                      45
 “Infection Control QA in the Patient Care
 Environment using ATP Bioluminescent
 Technology” Mark Gallivan, Un of Minnesota


               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)
                                                                                          46
“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
U.S. EPA Actions




                   48
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
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
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
Overview of the AD Testing
Program




                             52
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
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
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
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
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
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
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
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
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
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
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
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
Familiar Company Names
   3M
   AIRKEM Professional Products
   Clorox Company
   ECOLAB
   JohnsonDiversey
   Spartan Chemical Company



                                   65
3M
Number   Product Name           Status
328      HB Quat Disinfectant   Voluntarily Submitted
         Cleaner Concentrate




                                                        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                            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

                                                                  67
Clorox Company
#     Product Name         Claims    Claims in  Status
                           Tested    Compliance
                           HD/TB     HD/TB
170   Clean-Up             Yes/No    Yes/NA
171   Disinfecting                              Vol. Sub.
      Bathroom Cleaner
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.

                                                                68
ECOLAB
#    Product Name    Claims Tested   Claims in  Status
                     HD/TB           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      TB Claim Removed
90   Quorum Cleaner Yes/No           Yes/NA
91   Vortexx         Yes/No          Yes/NA
92   Multi-Quat      Yes/No          Yes/NA




                                                               69
ECOLAB (cont.)
#     Product Name         Claims    Claims in    Status
                           Tested    Compliance
                           HD/TB     HD/TB
93    65 Disinf. HD Acid   Yes/No    Yes/NA
      Bathroom Cleaner
94    Octave FS                                   Vol. Sub.
95    Exspor Base Conc.                           Vol. Sub.
131   ENVERROS             Yes/No    Yes/NA
      Sanimaster 4
287   Exspor Base Conc.    Yes/Yes   Yes/Yes
288   LD Base Conc.        Yes/No    Yes/NA



                                                              70
JohnsonDiversey
#     Product Name               Claims   Claims in  Status
                                 Tested   Compliance
                                 HD/TB    HD/TB
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                            Vol. Sub.
      Cleaner for Hospitals
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.
#     Product Name                 Claims    Claims in    Status
                                   Tested    Compliance
                                   HD/TB     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                 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,
    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
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

								
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