OFFICE OF CHEMICAL SAFETY -, *i .-*zn AND POLLUTION .

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f\UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION-, *i .-*znJUL 2Ms. Patti GolickSenior Regulatory Services AssociateLonza Inc.90 Boroline RoadAllendale, NJ 07401Subject:Lonzagard RCS-128EPA Registration Number 6836-347Notification Application Dated June 24, 2014EPA Received June 26, 2014Dear Ms. Golick:This letter acknowledges receipt of the notification identified above submitted under theprovisions of section 3 (c) 9 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),as amended and PR Notice 98-1 0 and 40 CFR 1 52.46.Proposed Notification To add the additional brand name "Lonzagard RCS 128"Based on a review of the submitted information, this notification is acceptable. A copy hasbeen inserted in your file for future reference.Should you have any questions or comments concerning this letter, please contact DrusillaCopeland at (703) 308-6224.Sincerely,Drusilla CopelandRegulatory Management BranchAntimicrobials Division (751 OP)

"Please read instructions on reverse before completing form.TTiT AJtLJL A.Form Approved, OMB No. 2070-0060, Approval expires 05-31-98Uif - States.Environmental rrotection AgencyWashington, DC 20460Q Registrati "Q Amendment Other:LS \i/'tOPP Identifier NumberApplication for Pesticide - Section 12. EPA Product Manager1.Company/Product Number6836-3474. Company/Product (Name)PM#tXJNone j Restricted316. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(I), my product is similaror identical in composition and labeling to:Lonzagard RCS-1285. Name and Address of Applicant (Include ZIP Code)Lonza Inc.90 Boroline RoadAllendale, NJ 07401 3. Proposed ClassificationVelma NobleEPA Reg. No.Product Name.„I Check if this is a new addressSection - III Amendment - Explain below. Resubmission in response to Agency letter dated[XI Notification - Explain below. I Final printed labels in response to Agency letter datedI I "Me Too" ApplicationI I Other - Explain belowExplanation: Use additional page(s) if necessary. (For Section I and Section II.)*Not Subject to PRIA*Notification of Additional Brand Name per PR Notice 98-10This notification is consistent with the provisions of PR-Notice 98-10 and EPA regulations at 40 C FR 152.46, and no otherchanges have been made to the labeling or the confidential statement of formula of this product. I understand that it is aviolation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification, is notconsistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product may be in violation of FIFRA and I may besubject to enforcement action and penalties under sections 12 and 14 of FIFRA.Sianature: X r XlGl OO\Date:Section - III1. Material This Product Will Be Packaged In:Child-Resistant PackagingUnit Packagingn Yes*D Yesn NO* Certification must besubmittedn NOWater Soluble PackagingIf "Yes" mt P kag'ng wgt-3. Location of Net Contents Information LabelLJ ContainerNo. percontainerD Noif "Yes"Package wgt.4. Size(s) Retail Container.6. Manner in Which Label is Affixed to ProductAWS l 1 1 Lithograph Paper gluedD Stenciled2. Type of ContainerI Metal[ 1 PlasticNo. perI Glasscontainer[ 1 Paper- !Jf 1 Other (Specify) Bag 5. Location of Label Directions'"'." '.} '.S.i'iT.:-. On Label' ' "'- 1 J On labeling accompanying .productE3 Other'„. t t- -,ttI I.t"tSection - IVt L.ii*-I1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application)NamePatti GolickTitleEPA Form 8570-1 (Rev. 8-94) Previous editions are obsolete'- 'Telephone No. (Iriolude Area Code)Sr. Regulatory Services Associate201-316-9293 L/6. Date Application ReceivedCertificationPatti Golick'cI certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I acknowledgethat any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.,f jr S-X - C J(C JL \L "-Lt, [(Stamped); i; :T :Sr. Regulatory Services Associate6/24/14White- EPA File Copy (original) Yellow- Applicant Copy

,onzaVia FedExLonza Inc.90 Boroline RoadAllendale, NJ 07401, USAMs. Velma Noble, PM-31Document Processing Desk (NOTIF)Office of Pesticide Programs (7504P)US Environmental Protection AgencyRoom S-4900, One Potomac Yard2227 S. Crystal DriveArlington, VA 22202Patti GolickSpecialty IngredientsRegulatory AssuranceSUBJECT:Tel 201-316-9293Fax 201-696-3463Patti.golick@lonza.comJune 24, 2014Lonzagard RCS-128, EPA Reg. No. 6836-347Notification of Additional Brand NameDear Ms. Noble:I am submitting an application to request the following additional brand name to the abovereferenced product:Lonzagard RCS 128Please find enclosed the Application for Notification in support of this request.If you have any questions or need any additional information, please feel free to contact me at201-316-9293 or at patti.golick@lonza.com.Sincerely,Lonza Inc.t. (- C It-CCCC I CCPatti GolickSr. Regulatory Services AssociateCL

Note to reviewer:[Items in brackets [AAA] are optional and may/may not be included on final label]{Items in braces {AAA} are for information purposes and will not appear on final label}LONZAGARDRCS-128[One-Step Disinfectant][Cleaner - Sanitizer - Fungicide - Mildewstat - Virucide* - Deodorizer][for Homes, Restaurants, Hospitals, Institutional and Industrial Use] [Effective in hard water up to 250 ppm hardness (calculated as CaCO3) in the presence of 5% serumcontamination][[Citrus], [Floral], [Fresh], [Lavender], [Lemon], [Lime], [Mint], [Peppermint], [Pine], [Woody] [Scent] [Scented][Fragrance] [Odor]]e o o[Formulated for Effective Farm Premise Sanitation][Formulated for Effective Poultry Premise Sanitation][Formulated for Effective Swine Premise Sanitation][Formulated for Effective Mushroom Farm Sanitation][Formulated for Veterinary Practice / Animal Care / Animal Laboratory Disinfection][For use in federally inspected meat and poultry plants][ Staphylocidal Pseudomonacidal Bactericidal Salmonellacidal Fungicidal « Virucidal*]Active Ingredients:Octyl decyl dimethyl ammonium chlorideDioctyl dimethyl ammonium chlorideDidecyl dimethyl ammonium chlorideAlkyl (C14, 50%; C12, 40%; C16, 10%) dimethyl benzyl ammonium chlorideOther %KEEP OUT OF REACH OF CHILDRENDANGER[PELIGRO]See [left] [side] [right] [back] panel for Precautionary Statements and First AidEPA Reg. No. 6836-347EPA Est. No. (insert EPA Establishment No. here)Net Contents (insert container size here)[DOTsymbols][Country of origin (insert country)][Manufactured in (insert country)][Barcode]Manufactured by:Lonzalnc.90 Boroline RoadAllendale, NJ 07401Lonzagard RCS-128EPA Reg. No. 6836-347EPA Draft Label 2014-06-26Page 1 of 19

PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS AND DOMESTIC ANIMALSDANGER. Corrosive. Causes irreversible eye damage and skin burns. Do not get in eyes, on skin, or onclothing. Wear protective eyewear (goggles, face shield or safety glasses), protective clothing and protective(rubber or chemical resistant) gloves. Harmful if swallowed or if absorbed through the skin. Wash thoroughlywith soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet.Remove contaminated clothing and wash clothing before reuse.FIRST AIDIF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, ifpresent, after first 5 minutes, then continue rinsing eye.IF ON SKIN OR CLOTHING: Take off contaminated clothing. Rinse skin immediately with plenty of water for15-20 minutes.IF SWALLOWED: Call a poison control center or doctor immediately for treatment advice. Have person sip aglass of water if able to swallow. Do not induce vomiting unless told to do so by a poison control center ordoctor. Do not give anything by mouth to an unconscious person.NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage.Call a poison control center or doctor for treatment advice. Have the product container or label with you whencalling poison control center or doctor or going for treatment.{Note to reviewer: If container size is 5 gallons or larger, the following Environmental Hazards statements will beused:}ENVIRONMENTAL HAZARDSDo not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other watersunless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES)permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluentcontaining this product to sewer systems without previously notifying the local sewage treatment plant authority.For guidance, contact your State Water Board or Regional Office of the EPA.Lonzagard RCS-128EPA Reg. No. 6836-347EPA Draft Label 2014-06-26Page 2 of 19

/\/"V{Note to reviewer: The following on Pages 3-7 is considered optional marketing language.}Concentrate [Concentrated]Disinfects [Disinfectant]Cleans [Cleaner]Deodorizes [Deodorant]This product contains no [phosphates] [or] [phosphorous compounds].Lonzagard RCS-128:« delivers non-acid disinfectant and cleaning performance in an economical concentrate.o deodorizes by killing microorganisms that cause offensive odors. eliminates 99.9% of Staphylococcus aureus and Klebsiella pneumoniae in 15 seconds. [improves labor results by] effectively controls [controlling] malodors.« is effective at controlling mold and mildew odor on mattresses, pillows and shower curtains. {Not for Use inCalifornia}« is effective yet economical. is a complete, chemically balanced disinfectant [and sanitizer] [that provides clear use solutions even in thepresence of hard water].'. is a [concentrated] [one-step] [Hospital Use] disinfectant cleaner that is effective against a broad spectrumof bacteria, is virucidal* [including HIV-1, the AIDS Virus and Hepatitis B Virus and Hepatitis C Virus],fungicidal, and inhibits the growth of mold and mildew, and their odors, when used as directed. [is a heavy duty disinfectant cleaner that] cleans, disinfects and deodorizes in one labor saving step. is a proven "one-step" disinfectant - cleaner - sanitizer - fungicide - mildewstat - virucide* which js effectivein water up to 250 ppm hardness in the presence of 5% serum contamination. is a [versatile] disinfectant and sanitizer for hard, nonporous nonfood contact surfaces in Veterinarian, AnirnaLcare and .Farm Premise applications. is an economical concentrate that can be diluted for use with [trigger sprayers], [and or] [pressuresprayers]. is an effective one-step sanitizer-cleaner for use on non-food hard, nonporous contact surfaces.« is formulated for use in daily maintenance programs with a balance of detergents, biocides and malodorcounteractants that deliver effective cleaning, disinfecting and malodor control,o Kills [eliminates] [Destroys] HIV virus in fast Oust] 1 minute [contact time]» Kills [eliminates] [Destroys] flu virus in fast O'ust] 1 minute [contact time]«[Kills] [Eliminates] [Removes] [Destroys] (Insert pathogen or pathogens from lists on pages 13-14) on [precleaned] environmental surfaces [Kills] [Eliminates] [Removes] [Destroys] [Germs] [Bacteria] [Viruses*] [on [pre-cleaned] environmentalsurfaces] kills Norovirus [in 5 minutes] at 1:128 dilution [1 oz. per gallon]« kills Rotavirus [in 5 minutes]« leaves a clean fresh scent. meets AOAC efficacy standards for hospital disinfectants. meets Sanitizer Test standards for non-food contact sanitizers.o provides long lasting freshness against tough [pet] odors such as odors from litter boxes and pet accidents,o Provides [non food contact] sanitization [eliminates 99.9%] in fast Oust] 15 second[s] [contact time]« Provides Norovirus efficacy in fast Oust] 5 minutefs] [contact time] Sanitizes in fast Oust] 15 second[s] [contact time] Saves [Labor] times will disinfect, clean and deodorize surfaces in rest rooms and toilet areas, behind and under sinks andcounters, garbage cans and garbage storage areas, and other places where bacterial growth can causemalodors. will not leave grit or soap scum.Cross-contamination is of major housekeeping concern. Lonzagard RCS-128 has been formulated to aid in thereduction of cross-contamination on treated surfaces not only in hospitals, but in schools, institutions andindustry.Lonzagard RCS-128EPA Reg. No. 6836-347EPA Draft Label 2014-06-26Page 3 of 19

cThis product is effective at controlling mold and mildew on shower curtains.This product may be applied through low-pressure sprayers.This product is for use in household and commercial humidifiers. Use of this product will control unpleasant[malodors] odors.Use this product to clean, sanitize and disinfectant non-porous ambulance equipment and surfaces. Rinse withclean water all equipment that will come in prolonged contact with skin before reuse.This product may be used to deodorize coolers, buckets, garbage pails and other areas where strong odors maydevelop.[Quickly] Cleans [and sanitizes] every day kitchen messes.Cleans [and disinfects] every day kitchen messes.Cuts through tough grease [and grime].To disinfect food processing facilities: Spray surfaces with solution and allow to remain wet for 5 minutes. Rinsefood contact surfaces with potable water prior to reuse.Use [on] [to clean and disinfect] nonporous athletic mats, wrestling mats, gymnastic mats, exercise equipmentand training tables.Lonzagard RCS-128 is a phosphate free, germicidal detergent effective in the presence of a moderate amountof organic soil on hard nonporous surfaces found at mushroom farms. Lonzagard RCS-128 has been designedfor use between mushroom crops. Areas of intended use include breezeways and track alleys before spawning,inside and outside walls of mushroom houses, lofts, floors

21.07.2014 · TTiT A Uif - States . Q Registrati " JtLJL A. Environmental rrotection Agency Q Amendment Washington, DC 20460 : Other OPP Identifier Number Application for Pesticide - Section 1 1 . Company/Product Number 6836-347 4. Company/Product (Name) Lonzagard RCS-128 5. Name and Address of Applicant (Include ZIP Code) Lonza Inc. 90 Boroline Road .