UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, DC 20460OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTIONJanuary 26, 2021Coleen GerberPeroxyChem2005 Market St.Suite 3200Philadelphia, PA19103Subject:Label Amendment: Adding the Emerging Viral Pathogens ClaimProduct Name: VIGOROX LIQUID SANITIZER AND DISINFECTANTEPA Registration Number: 65402-1Application Date: 9/4/2020Decision Number: 565930Dear Ms. Gerber:The amended label referred to above, submitted in connection with registration under the FederalInsecticide, Fungicide and Rodenticide Act, as amended, is acceptable. This approval does notaffect any conditions that were previously imposed on this registration. You continue to besubject to existing conditions on your registration and any deadlines connected with them.A stamped copy of your labeling is enclosed for your records. This labeling supersedes allpreviously accepted labeling. You must submit one copy of the final printed labeling before yourelease the product for shipment with the new labeling. In accordance with 40 CFR 152.130(c),you may distribute or sell this product under the previously approved labeling for 18 monthsfrom the date of this letter. After 18 months, you may only distribute or sell this product if itbears this new revised labeling or subsequently approved labeling. “To distribute or sell” isdefined under FIFRA section 2(gg) and its implementing regulation at 40 CFR 152.3.Because you have opted to add statements pertaining to emerging viral pathogens to your labelas described in the August 19, 2016, Guidance to Registrants: Process For Making ClaimsAgainst Emerging Viral Pathogens Not On EPA-Registered Disinfectant Labels ion/files/201609/documents/emerging viral pathogen program guidance final 8 19 16 001 0.pdf, you aresubject to the following additional terms of registration:1. You may make statements pertaining to emerging viral pathogens only through thefollowing communications outlets: technical literature distributed exclusively to healthcare facilities, physicians, nurses and public health officials, "1-800" consumerinformation services, social media sites and company websites (non-label related). Thesestatements shall not appear on marketed (final print) product labels.FQPA Label Acceptable v.20150320
Page 2 of 3EPA Reg. No. 65402-1Decision No. 5659302. Your statements pertaining to emerging viral pathogens must adhere to the formatapproved on the Agency-accepted master label.3. You may make statements pertaining to emerging viral pathogens only upon a diseaseoutbreak that meets all the following criteria:a. The causative organism must be a virus that causes an infectious disease that hasappeared in a human or animal population in the U.S. for the first time, or that mayhave existed previously but is rapidly increasing in incidence or geographic range.i. For human disease, the outbreak is listed in one of the following Centers forDisease Control (CDC) publications:A. CDC Current Outbreak List for “U.S. Based Outbreaks”(www.cdc.gov/outbreaks),B. CDC Current Outbreak List for “Outbreaks Affecting International Travelers”with an “Alert” or “Advisory” classification (www.cdc.gov/outbreaks) (alsoreleased through the CDC’s Health Alert Network (HAN) notificationprocess)C. Healthcare-Associated Infections (HAIs) Outbreaks and Patient Notificationspage (www.cdc.gov/hai/outbreaks)ii. For animal disease, the outbreak is identified as an infectious disease outbreak inanimals within the U.S. on the World Organization for Animal Health (OIE) WeeklyDisease Information page(www.oie.int/wahis 2/public/wahid.php/Diseaseinformation/WI).A. The CDC or OIE has identified the taxonomy, including the viral family and/orspecies, of the pathogen and provides notice to the public of the identity of theemerging virus that is responsible for an infectious disease outbreak. Based on thetaxonomy of the outbreak pathogen identified by the CDC or OEI, the pathogen'sviral subgroup is enveloped.B. The virus can be transmitted via environmental surfaces (non-vectortransmission), and environmental surface disinfection has been recommended bythe CDC, OIE or EPA to control the spread of the pathogen.4. You may begin communicating statements pertaining to emerging viral pathogens onlyupon CDC or OIE’s publication per term 3.a. of an outbreak of an emerging viralpathogen meeting all of the criteria of term 3. You must cease and remove all such nonlabel communications intended for consumers no later than 24 months after the originalpublication of the outbreak per term 3.a., unless the Agency issue written guidance to thecontrary due to continued public health concerns. The emerging pathogen claim languagemay remain on the master label.
Page 3 of 3EPA Reg. No. 65402-1Decision No. 5659305. Terms from points 1 through 4 above shall become immediately void and ineffective ifregistration for use against Avian Reovirus is suspended or cancelled or no longer meetsthe criteria for a disinfectant claim (see EPA Product Performance Test Guideline810.2200). In addition, terms B.1 through B.4 above shall become immediately void andineffective upon your receipt of evidence of ineffectiveness against any pathogen in aless-resistant Spaulding category.Should you wish to add/retain a reference to the company’s website on your label, then please beaware that the website becomes labeling under the Federal Insecticide Fungicide and RodenticideAct and is subject to review by the Agency. If the website is false or misleading, the productwould be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40CFR 156.10(a)(5) list examples of statements EPA may consider false or misleading. In addition,regardless of whether a website is referenced on your product’s label, claims made on thewebsite may not substantially differ from those claims approved through the registration process.Therefore, should the Agency find or if it is brought to our attention that a website contains falseor misleading statements or claims substantially differing from the EPA approved registration,the website will be referred to the EPA’s Office of Enforcement and Compliance.Your release for shipment of the product constitutes acceptance of these conditions. If theseconditions are not complied with, the registration will be subject to cancellation in accordancewith FIFRA section 6. If you have any questions, you may contact Aline Heffernan at 703-3478602 or via email at [email protected],Demson Fuller, Product Manager 32Regulatory Management Branch IAntimicrobials Division (7510P)Office of Pesticide ProgramsEnclosure: stamped label
VigorOx Liquid Sanitizer and DisinfectantEPA Registration No. 65402-1EPA Est. No. 65402-NY-00101/26/2021FIRST AIDx Hold eye open and rinse slowly and gently withwater for 15-20 minutes.x Remove contact lenses, if present, after the first5 minutes, then continue rinsing eye.x Call a poison control center or doctor fortreatment advice.x Take off contaminated clothing.x Rinse skin immediately with plenty of water for15-20 minutes.x Call a poison control center or doctor fortreatment advice.x Move person to fresh air.x If person is not breathing, call 911 or anambulance, then give artificial respiration,preferably by mouth-to-mouth if possible.x Call a poison control center or doctor for furthertreatment advice.x Call a poison control center or doctorimmediately for treatment advice.x Have person sip a glass of water if able toswallow.x Do not induce vomiting unless told to do so by apoison control center or doctor.x Do not give anything by mouth to anunconscious person.65402-1ACTIVE INGREDIENTS:Peroxyacetic Acid . 5.1%Hydrogen Peroxide . 21.7%OTHER INGREDIENTS: . 73.2%TOTAL: . 100.0%KEEP OUT OF REACH OF CHILDRENIf in Eyes:If on Skin orClothing:DANGERVigorOx Liquid Sanitizer and Disinfectant is forinstitutional/industrial sanitizing of previously cleaned nonporous food contact surfaces in:x Dairies, Wineries, Breweries and Beverage Plantsx Meat and Poultry Processing/Packaging Plantsx Milk and Dairy Products Processing/Packing Plantsx Seafood and Produce Processing/Packing Plantsx Food Processing/Packing Plantsx Egg Processing/Packing Equipment Surfacesx Eating EstablishmentsVigorOx Liquid Sanitizer and Disinfectant is forInstitutional/industrial sanitizing of previously-cleaned, hard, non-porousfood-contact surfaces such as:x Eating, Drinking, and Food Preparation Utensilsx Countertops and Food Preparation Surfacesx Tablewarex Plastic, Glass and Metal Bottles (rinse)VigorOx Liquid Sanitizer and Disinfectant is for sanitizing hardinanimate, non-food contact surfaces, (general environmental surfaces)VigorOx Liquid Sanitizer and Disinfectant is for use in thedisinfection of hard, non-porous surfaces in general commercial andmedical environments such as:x Hospitals, Health Care Facilities, Veterinary Hospital/Clinics, Animalx Life Science Labs, Pharmaceutical Facilities and Equipmentx Schools, Colleges, Recreational Facilities, Office Buildingsx Livestock Premises, Poultry Premises, Poultry Hatcheries, AnimalHousing Facilitiesx Retail and Wholesale Establishmentsx Bathroom PremisesVigorOx Liquid Sanitizer and Disinfectant is for use as a coarsespray for surfaces to be sanitized or disinfected.VigorOx Liquid Sanitizer and Disinfectant can be used with the nonfoaming agent, Peradigm , as an antimicrobial container rinse and forhard, non-porous surface disinfection.VigorOx Liquid Sanitizer and Disinfectant is for sanitization ofhatching eggs.VigorOx Liquid Sanitizer and Disinfectant is for sanitization of shelleggs.If Inhaled:If Swallowed:Note to Physician: Probable mucosal damage may contraindicate theuse of gastric lavage.This product is not to be used as a terminal sterilant/high-level disinfectanton any surface or instrument that (1) is introduced directly into the humanbody, either into or in contact with the bloodstream or normally sterileareas of the body, or (2) contacts intact mucous membranes but whichdoes not ordinarily penetrate the blood barrier or otherwise enter normallysterile areas of the body. This product may be used to clean ordecontaminate critical or semi-critical medical devices prior to sterilizationor high-level disinfection.VigorOx Liquid Sanitizer and Disinfectant may be used to remediateand restore hard, non-porous, environmental surfaces impacted by moldand mildew and odors caused by them.VigorOx Liquid Sanitizer and Disinfectant may be used to control moldand mildew and odors caused by them in environments such as:x Schools, colleges, industrial facilities, dietary areas, office buildings,recreational facilities, retail and wholesale establishments.x Animal hospitals, veterinary clinics, animal life science laboratories,farms, kennels, kennel runs, catteries, cages, feeding and wateringequipment, pet shops, zoos, pet animal quarters, poultry premises,trucks, hatcheries, live stock quarters, stables, stalls, and pens.x Packinghouses, food processing and rendering plantsx Healthcare facilitiesx Commercial floral shopsx Hairdressing salons/barber shopsx Pharmaceutical/cosmetic facilitiesVigorOx Liquid Sanitizer and Disinfectant may be used for he nonpesticidal purpose of cleaning room surfaces by fogging.VigorOx Liquid Sanitizer and Disinfectant is for use as anantimicrobial container rinse to control beverage spoilagemicroorganisms.VigorOx Liquid Sanitizer and Disinfectant may be used to controlalgal and slime-forming bacterial growth in livestock water. (Not for Usein California)VigorOx Liquid Sanitizer and Disinfectant is for use in thesanitization of ultra filtration and reverse osmosis (RO) membranes andtheir associated distribution systems.Manufactured by:PeroxyChem, LLC2005 Market St Ste 3200Philadelphia PA 19103-7014Net Contents: 55 Gallons (208 L) 495 lbs (224 kg)ESL 061819 REV012521Page 1 of 8
Precautionary StatementsHazards to Humans and Domestic AnimalsDANGERCorrosive. Causes irreversible eye damage and skin burns. Harmful ifswallowed. May be fatal if absorbed through skin. Do not get in eyes,on skin or on clothing. Wear protective eyewear (goggles, face shield, orsafety glasses), clothing and chemical resistant gloves.Washthoroughly with soap and water after handling and before eating,drinking or using tobacco. Remove contaminated clothing and washbefore reuse.Physical or Chemical HazardsStrong oxidizing agent. Mix only with water. At temperatures exceeding156 F, decomposition of VigorOx Liquid Santitizer and Disinfectantcould occur, releasing oxygen. The oxygen released could initiate orpromote combustion of other materials.Environmental HazardsThis pesticide is toxic to birds, mammals, fish and aquatic life. Do notdischarge effluent containing this product into lakes, streams, ponds,estuaries, oceans, or other waters unless in accordance withrequirements of a National Pollutant Discharge Elimination System(NPDES) permit and the permitting authority has been notified in writingprior to discharge. Do not discharge effluent containing this product tosewer systems without previously notifying the local sewage treatmentplant authority. For guidance contact your State Water Board orRegional Office of the EPA.DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a mannerinconsistent with its labeling.Sanitizing Hard, Non-Porous Food Contact Surfaces –Pathogenic OrganismsFor use in circulation cleaning and institutional/industrial sanitizing ofpreviously cleaned, hard, non-porous food-contact surfaces andequipment, such as food preparation surfaces, pipelines, tanks, vats,fillers, evaporators, pasteurizers and aseptic equipment in:x Dairies, Wineries, Breweries and Beverage Plantsx Meat and Poultry Processing/Packaging Plantsx Milk and Dairy Products Processing/Packing