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UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460
' DEC -7 2011
Ms. Tara Gomez OFFICE OF CHEMICAL SAFETYClorox Professional Products Company AND POLLUTION PREVENT10N
PO Box 493Pleasanton, California 94566-0803
Subject: CPPC ShowerEPA Registration No.: 67619-11 .Notification Date: 11/17/2011EPA Receipt Date: 11/18/2011
Dear Ms. Gomez,
This acknowledges the receipt of your notification, submitted under the provision of PRNotice 98-10 and FIFRA section 3(c)9.
Proposed Notification
• H1N1 label claims
General Comments
Based on a review of the submitted materials, your notifications for the addition of H1N1label claims on page 3 is acceptable and have been made a part of the records on file.
Should you have any questions or comments concerning this letter, you may contact meby telephone at (703) 308-0410 or by email at Harris.monishafotepa.gov or Jaclyn Carl bytelephone at (571) 384-5684 or by e-mail at [email protected]. When submitting informationor data in response to this letter, a copy of this letter should accompany the submission tofacilitate processing.
Sincer
Monisha HarrisProduct Manager (32)Regulatory Management Branch IIAntimicrobials Division (751 OP)
Pfetse read instruction* on r*v*rt* before cot ing form.
11
v>EPA
Form Approv OMB No. 2070-O06O. Approval expires 2-28
United States
Environmental Protection AgencyWashington, DC 20460
RegistrationAmendmentOther
I• ~i
-95 /OPP Identifier Number
TG0011
Application for Pesticide - Section I1. Company/Product Number
67619-11
4. Company/Product (Name)CPPC Shower
2. EPA Product Manager
Monisha Harris
PM*32
3. Proposed Classification
None Restricted
5. Name and Address of Applicant (Include ZIP Code)
Clorox Professional Products Companyc/o PS&RC; P. O. Box 493Pleasanton, CA 94566-0803
6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3)(b)(i), my product is similar or identical in composition and labelingto:EPA Reg. No.
Check if this is a new address Product Name
Section - II
Amendment - Explain below.
Resubmission in response to Agency letter dated.
Notification - Explain below.
Rnal printed labels in repsonse toAgency letter dated"Me Too" Application.
Other - Explain below.
Explanation: Use additional page(s) if necessary. (For section I and Section II.)
Notification of H1N1 label claims per Agency guidance listed on EPA website dated October 22, 2009 per PR Notice 95-2; see p. 3. 1 underlined label and 5clean labels are enclosed. This notification is consistent with the provisions of PR Notice 95-2 and EPA regulations at 40 CFR 152.46, and no other changeshave been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully makeany false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 95-2 and 40 CFR 152.46, this product maybe in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA.
Section - III1. Material This Product Will B« Packaged In:
Child-Resistant Packaging
Yes
No
• Certification mustbe submitted
If "Yes" No. perUnit Packaging wgt. container
Water Soluble Packaging
| Yes
No
If "Yes-Package wgt
No. percontainer
2. Type of Container
MetalPlasticGlassPaperOther (Specify)
3. Location of Net Contents Information
Label J Container
4. Size(s) Retail Container 5. Location of Label Directions
6. Manner in Which Label is Affixed to Product LithographPaper glStencilePaper glued- ifed
f~| Other
Section - IV
Name
J. Evelyn Lawson
1. Contact Point /Complete items directly below for identification of individual to be contacted, if necessary, to proofs this applicetion.l
Title Telephone No 'In-hde Area Code)
Federal Registration Specialist (925) 425-6842
CertificationI certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.I acknowledge that any knowlinglly false or misleading statement may be punishable by fine or imprisonment orboth under applicable law.
2. Signature
4. Typed Name
Tara Gomez
3. Title
Federal Registration Specialist
5. Date
11/17/2011
6. Jute ApplicationReceived
'. Stamped)
EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete. White - EPA Fife Copy (original) Yallow - Applicant Copy
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Note: Bold, italicized text is information lor the reader and is not part ol the label. [Bracketed intormation is optional text.]
rEPA Reg. No. 67619-11 CPPC Shower
Page 1 of 5
-$•
i ^^^ • •• «Osteftevisw
C^^^^ ^^^^ ^^^^ Vmfsm&ty
PPC
SHOWER
T
c c
c c c c c c
c c cc e c
c cc c c. c t
c e cc c c e c- e e e
c c
c cc c c c c c
e cc c c c c c
ACTIVE INGREDIENTS:Sodium Hypochlorite 0.55%Other Ingredients: 99.45%Total: 100.00%
Available Chlorine = 0.52%
KEEP OUT OF REACH OF CHILDRENCAUTION'Use only in we"ventilated areas.
See back label for additional precautionary statements
NET CONTENTS
Clorox Customer Assistance 1-888-797-7225. Any Questions? The experts at Clorox are standing by toanswer any ot your questions, -or- Questions? Comments? Call [toll-free) 1-888-797-7225.Satisfaction Guaranteed]!] At Clorox we have prided ourselves in making consistent quality products[for over 75 -or- years], and we are dedicated to ensuring your total satisfaction with our product.If you are not completely satisfied, please call the number below -or-1-888-797-7225.
Contains no phosphorus.Mfd. for & ©2004 Clorox Professional Products Company, Oakland, CA 94612Made in the USAEPA Reg. No. 67619-11EPAEst. No. 5813-CA-03.GA-01(Actual EPA Est. No. in code below)Visit us at www.clorox.com R0527021
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Note: Bold, italicized text is Information tor the reader and Is not pan ot the label. [Bracketed information is optional text.] EPA Reg. No. 67619-11 CPPC ShowerPage 2 of 5
PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS & DOMESTIC ANIMALS '
CAUTION: Causes moderate eye injury. Do not get in eyes or on clothing. Vapors may irritate. Use only in well ventilated areas. Avoid prolonged breathing of vapors.Not recommended for use by persons with heart conditions or chronic respiratory problems such as asthma, emphysema or obstructive lung disease.
FIRST AID: If in eyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present after the first 5 minutes, thencontinue rinsing. If inhaled: Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Call a poison control center or doctor for further treatment advice. Have the product container or label with you when calling a poison controlcenter or doctor or going for treatment. For further information, call 1-888-797-7225. -or- Questions? Call 1-888-797-7225.
PHYSICAL. AND CHEMICAL HAZARDS: This product contains bleach. Do not use this product with other chemicals such as ammonia, toilet bowl cleaners, rustremovers, or acid, as this releases hazardous gases. [Avoid contact with clothes, fabric, unfinished wood, rubber, painted and paper surfaces. Do not use onaluminum, silver or chipped enamel. APPLY CAREFULLY - This product contains bleach.]
STORAGE AND DISPOSAL:
STORAGE: Store this product in a cool [dry] area, [away from direct sunlight and heat] to avoid deterioration.DISPOSAL: Do not reuse empty container, -or- Refill only with this product. Offer empty container for recycling. If recycling is not available, discard container in trash.
DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labeling.
Avoid prolonged breathing of vapor. Use only in well ventilated areas. Open windows and turn on fans before use. If the vapors bother you, leave the room while productis working. c c
For surfaces that may come in contact with food, a potable water rinse is required.
Alternate language for Refill Bottle: To Refill [Spray Bottles]
Remove1. Remove trigger
sprayer fromempty bottle
Pour2. Unscrew cap on
refill and pour contentsdirectly into empty bottle.
Use3. Replace trigger
sprayer and use asyou normally would. c c
G C C G G
C C G C C C
t C C C C C
C C C: c €
c c c
DISINFECTION c e c c c c
To [clean and] disinfect [and deodorize] hard, nonporous surfaces: [Set trigger to SPRAY or FOAM.] Spray 6-8 inches from surface until surface is l̂iocoiighly wet.Let stand for contact time listed below. Allow to air dry at room temperature. No rinsing required. Gross filth should be removed prior to disinfecting. [If streaking isobserved, wipe with a [cloth or] paper towel.] « c
Pathogen:Contact Time:
Bacteria1 minute
Viruses1 minute
Parvoviruses5 minutes
-and/or-
ORGANISMS:Bacteria:Enterococcus faecalis, vancomycin resistant (VRE)
[ATCC51575]*Escherichiacoli (E. coli) [ATCC 11229]*Klebsiella pneumoniae [ATCC 4352]**Legionella pneumophilia [ATCC 33153]*Listeria monocytogenes [ATCC 19117]**Salmonella choleraesuis [ATCC 10708]*Shigella dysenteriae [ATCC 11835]*Staphylococcus aureus [ATCC 6538]*Staphylococcus aureus, methicillin resistant (MRSA)
[ATCC 33592]*Streptococcus pyogenes [ATCC 12344]*
Viruses:Adenovirus type 2 [ATCC VR-846]
[(Strain Adenoid 6)]"[(common cause of respiratory infections)]
Herpes simplex virus type 2 [ATCC VR-734][(Strain G)]** [(causative agent of genital herpes)]
HIV type 1 [(Strain HTLV-IIIB)]*Human Coronavirus [ATCC VR-740]
[(Strain 229E)]**[([additional] causative agent of the common cold)]
Influenza A [ATCC VR-544] [(Strain Hong Kong)]**[(representative of the common flu virus)]
Poliovirus type 1 [ATCC VR-1000][(Strain Brunhilde)]**
Respiratory syncytial virus [ATCC VR-26][(Strain Long)]**[(cause of respiratory infections in infants)]
Rhinovirus type 37 [ATCC VR-1147][(Strain 151-1)]**[([leading] causative agent of the common cold)]
Rotavirus [(Strain WA)]**[(causative agent of viral diarrhea)]
Parvoviruses:Canine parvovirus [ATCC VR-2017]
[(Strain Cornell)]***Feline panleukopenia virus [ATCC VR-648]
[(Strain Philips-Roxane)]***[(feline parvovirus)]
*30 second contact time**1 minute contact time***5 minute contact time
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Claims:
• [30 second] broad spectrum no-rinse disinfectant• A Clorox breakthrough in bleach disinfection• A one-step cleaner/disinfectant• Aids in reducing -or- in the reduction of cross-contamination between treated
surfaces• Assures proper dilution strength, product effectiveness and standardizes
technique• Bactericide -or- Bactericidal• Broad spectrum disinfectant [with Clorox Bleach]• [Cleans and] disinfects [hard, nonporous surfaces]• [Cleans and] disinfects (insert surface(s) -and/or- surface material(s)
from tables 1-3)• Cleans, deodorizes and disinfects• Deodorizes by killing the bacteria that cause odors• Disinfects [and deodorizes]• Disinfects and deodorizes by killing bacteria and their odors• Disinfects hard nonporous surfaces throughout the (insert use site(s)
from tables 1-3)• Disinfecting formula• Easy and convenient disinfecting throughout the (insert use site(s) from
tables 1-3)• Easy, one-step cleaning and disinfecting• Effective against -or- Kills (insert any organism(s) from organism
list above) [in the presence of organic soil [(5% blood serum)]]
Use Sites: See Tables One-Three
• Effective against -or- Kills a wide range of bacteria including Staphylococcusaureus and Salmonella choleraesuis [in the presence of organic soil[(5% blood serum)]]
• [Effectively] disinfects [hard, nonporous] [environmental] surfaces• Eliminates odors at their source [caused by bacteria]• Eliminates -or- Reduces odors [caused by bacteria]• Exhibits effective virucidal activity• Kills [many common] bacteria and viruses• Kills odor-causing bacteria• Kills -or- Effective against bacteria• Kills -or- Effective against viruses• Leaves no residue that may contribute to the development of
resistant strains of microorganisms• Multi-purpose disinfectant• One-step cleaner and disinfectant• One-step cleaning and disinfecting [saves time]• Reduces the risk of infection and cross-contamination• Staphylocidal• Streptocidal• The easy, convenient way to clean and disinfect with Clorox Bleach• [The] quick -and/or- easy -and/or- convenient way to disinfect• [This product] controls the spread of bacteria -and/or- viruseS,prj rrfigt hard,
nonporous surfaces c• Use where control of the hazards of cross-contamination between treated
surfaces is of prime importance• Virucide -or- Virucidal
c c c c c e
Specific Instructions for Use Against HIV-1 c c c e c c
This product kills HIV-1 on precleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings or other settings injwhich thereis an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiledivitn mood or bodyfluids can be associated with the potential for transmission of Human Immunodeficiency Virus (HIV-1) (associated with AIDS). c c
c c c c c oSpecial Instructions tor using this product to clean and decontaminate against HIV-1 on surfaces/objects soiled with blood/body fluids: c
Personal Protection: When handling items soiled with blood or body fluids, use disposable impervious gloves, gowns, masks and eye coverings.Cleaning Procedure: Blood and other body fluids must be thoroughly cleaned from surfaces and other objects before applying this product. Allow surfaces to remainwet for 30 seconds, let air dry.Disposal of Infectious Materials: Use disposable impervious gloves, gowns, masks and eye coverings. Blood and other body fluids should be autoclaved and disposedof according to local regulations for infectious waste disposal.
Pandemic 2009 H1N1 Influenza A virus***
• This product has demonstrated effectiveness against influenza A2 virus and isexpected to inactivate all influenza A viruses including Pandemic 2009 H1N1(formerly called swine flu).
• Kills Pandemic 2009 H1N1 influenza A virus (formerly called swine flu).• Kills Pandemic 2009 H1N1 influenza A virus.
Claims:• Respiratory illnesses attributable to Pandemic 2009 H1N1 are caused by
influenza A virus. This product (Product Name) is a broad-spectrum hardsurface disinfectant that has been shown to be effective against influenza A2virus and is expected to inactivate all influenza A viruses including Pandemic2009 H1N1 (formerly called swine flu).
• This product has demonstrated effectiveness against influenza A2 virus and isexpected to inactivate all influenza A viruses including Pandemic 2009 H1N1influenza A virus.
"'per Agency guidance dated October 22, 2009 "Guidance lor Testing and Labeling Claims against Pandemic 2009 H1N1 Influenza A Virus (formerly called Swine Flu)"www.epa.gov/oppad001/hln1-guide.html
R0527021
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JL
EPA Reg. No. 67619-11 CPPC ShowerPage 4 ot 5
CLEANING AND STAIN REMOVAL
To clean -and/or- remove stains: [Set trigger to SPRAY or FOAM.] Spray, wait a few minutes, and allow to air dry. [If streaking is observed, wipe with a [cloth or]paper towel.]
Claims:• Cleans• Removes• Removes stains
Stains/Soils:• Body oils• Blood• Coffee [stains]• Dead skin•Dirt
(insert stain(s) from list below)
• Fecal matter• Fingerprints• Food residue[s] -or- soil[s]• Fruit [stains]• Grease
•Grimep Laboratory stains1 Mildew stains1 Mold stains1 Other common soils -and/or- stains
• Other organic matter• Tea [stains]• Urine
GENERAL CLAIMS
' Convenient1 Does not contain mercury1 Does not contain nonylphenol ethoxylates (NPEs)
-and/or- alkylphenol ethoxylates (APEs)• Does not contain VOCs1 Easy and convenient to use• Easy to handle1 Eliminates [daily] mixing and measuring• Foam trigger eliminates airborne particles associated with sprays• Foam trigger helps to minimize potential overspray1 Low odor
• Mercury free• No measuring• No mixing• Nonylphenol ethoxylate (NPE) -and/or- alkylphenol ethoxylat^ (A,PR);fr,e'• Ready to use• Shelf-stable formula f c
• Stable for one year• The power of Clorox Bleach [without the strong odor]• VOC free
« c f r. t cc
SURFACE SAFETY CLAIMS< c r. c c
c ct t < f t
t c c
c
• Safe on most hard, nonporous surfaces• Safe for use on (insert surface material(s) from table 3)
• Will not harm [titanium-coated] stainless steel
TABLE ONE Veterinary:
USE SITESAnimal Housing FacilitiesAnimal Life Science Laboratories[Animal -or- Pet] Grooming FacilitiesEquine FarmsFarmsKennelsLivestock -and/or- Swine -and/or- Poultry FacilitiesPet AreasPet Shops -or- StoresSmall Animal FacilitiesVeterinary Clinics -or- FacilitiesVeterinary -or- Animal Hospitals
SURFACESanimal equipmentautomatic feederscagesfeed racksfountainspensstallstroughsveterinary care surfaceswatering appliances
| R0527021.qxt:R0527021 11/14/11 8:47 AM Pagr" • w ,•
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I?
EPA Reg. No. 67619-11 CPPC ShowerPage 5 of 5
USE SITESBarsCafeteriasCommercial -or- Institutional KitchensDelisFast Food Chains -or- RestaurantsFood Preparation and Processing AreasFood [Service -or- Processing] EstablishmentsFood Serving AreasOther Food Service EstablishmentsRestaurantsSchool Kitchens
TABLE TWO Food Service:
SURFACESany washable (food and non-food contact) surfacewhere disinfection is requiredappliancesdish racksdrain boardsfood casesfood traysfreezershoodsmicrowaves - exterior onlyoutdoor furnitureovens - exterior onlyrefrigerators - exterior onlysalad bar sneeze guardsstoves -or- stovetops
A potable water rinse is required for food contactsurfaces.Do not use on glassware, utensils, or dishes.
USE SITESAirplanesBlood BanksBowling AlleysButcher ShopsChurchesCollegesCorrectional FacilitiesDay Care CentersDormitoriesFactoriesFuneral HomesGrocery StoresGymnasiums -or- GymsHealth Club FacilitiesHotelsIndustrial FacilitiesLaundromatsLaundry RoomsLocker RoomsManufacturing Plants -or- FacilitiesMilitary InstallationsMotelsProduce AreasPublic AreasRecreational Centers -or- FacilitiesRestrooms -or- Restroom AreasSchool BusesSchoolsSheltersShower RoomsStorage Rooms -or- AreasSupermarketsTrains
TABLE THREE Miscellaneous/General:
SURFACES
[bathroom] fixtures[bath]tubsbehind and under countersbehind and under sinksbooster chairscabinetsceilingscell[ular] -or- wireless -or- mobile -or- digital phoneschairs[computer] keyboards[computer] monitorscounters -or- countertopscribsdesks[diaper -or- infant] changing tablesdiaper pailsdictating equipment [surfaces]doorknobsexterior -or- external toilet surfacesexterior -or- external urinal surfacesfaucetsfloorsgarbage -or-trash cans[grocery store -or- supermarket] cartshampershand railingsheadsetshighchairslampslinoleumother telecommunications equipment [surfaces]playpensshelvesshowers -or- shower stallssinksstall doorstablestelephones[tiled] wallstoilet rimstoilet seatstowel dispenserstoysvanity tops -or- vanities
C C C t C 1C C
C C
c rr c c c c '
SURFACE MATERIALS
[baked] enamelchrome[common] hard, nonporous [household -or-environmental] SutftCgS £fiberglass c cFormicaglassglazed ceramic [tile]glazed porcelainc c £ c c
laminated surfacfef' f
Marliteplastic [laminate]porcelain enamel cstainless steel o c Gsynthetic marblevinyl [tile]similar hard, nonporous surfaces
except for those excluded by the label
Not Recommended For Use On:aluminumbrassclear plasticcoppernatural marblepainted surfacessealed graniteunfinished woodwindows