Sanidate ® 12.0
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION February 2, 2017 Donna Bishel Director of Regulatory Affairs BioSafe Systems, LLC 22 Meadow Street East Hartford, CT 06108 Subject: Notification per PRN 98-10 – Formating Revisions Product Name: SaniDate 12.0 EPA Registration Number: 70299-18 Application Date: January 3, 2017 Decision Number: 524894 Dear Ms. Bishel: The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10 for the above referenced product. The Antimicrobials Division (AD) has conducted a review of this request for its applicability under PRN 98-10 and finds that the action requested falls within the scope of PRN 98-10. The label submitted with the application has been stamped “Notification” and will be placed in our records. Should you wish to add/retain a reference to the company’s website on your label, then please be aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide Act and is subject to review by the Agency. If the website is false or misleading, the product would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40 CFR 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 the website 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 false or 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. If you have any questions, you may contact Terria Northern at 703-347-0265 or via email at [email protected]. Sincerely, for John Hebert, Branch Chief Regulatory Management Branch I Antimicrobials Division (7510P) Office of Pesticide Programs Notification Label Acceptable v.20150821 SaniDate® 12.0 FOR COMMERCIAL USE (Alternate Brand Name: TerraStart) ACTIVE INGREDIENTS: Hydrogen Peroxide. .................. 18.5% Peroxyacetic Acid ...................... 12.0% OTHER INGREDIENTS: ........... 69.5% Total:........................................ 100.00 DANGER - PELIGRO STRONG OXIDIZING AGENT KEEP OUT OF REACH OF CHILDREN Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If you do not understand this label, find someone to explain it to you in detail.) FIRST AID If in eyes x Hold eye open and rinse slowly and gently with water for 15 – 20 minutes. x Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. x Call a poison control center or doctor for treatment advice. If on skin or x Take off contaminated clothing. clothing x Rinse skin immediately with plenty of water for 15 – 20 minutes. x Call a poison control center or doctor for treatment advice. If inhaled x Move person to fresh air. x If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if possible. x Call poison control center or doctor for treatment advice. If swallowed x Call poison control center or doctor immediately for treatment advice. x Have person sip a glass of water if able to swallow. x Do not induce vomiting unless told to do so by the poison control center. x Do not give anything by mouth to an unconscious person. Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-222-1222 for emergency medical treatment information. NOTE TO PHYSICIAN - Probable mucosal damage may contraindicate the use of gastric lavage. Sold by: BioSafe Systems LLC, 22 Meadow St, East Hartford, CT 06108; (888) 273-3088 EPA Registration No.: 70299-18 Batch Code ______ EPA Establishment No.: 067441-IL-001, 089546-NV-001, 082521-GA-001 Net Contents: (5, 30, 55, 275, 330 gallons) 70299-18 SaniDate£ 12.0 EPA Reg. No. 70299-18 Notification 02/02/2017 LabelL version (V11) Redline Copy January 3, 2017 Page 1 of 17 PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGER: CORROSIVE. Causes irreversible eye damage and skin burns. May be fatal if inhaled or absorbed through skin. Do not get in eyes, on skin, or on clothing. Harmful if swallowed. Do not breathe vapors or spray mist. When exposed to vapors or spray mist wear a respirator with an organic vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval prefix TC-14G), or a NIOSH approved respirator with an organic vapor (OV) cartridge or canister with any N, R, P, or HE prefilter. Wear chemical resistant goggles, rubber gloves and protective clothing when handling this product. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and wash before reuse. PHYSICAL AND CHEMICAL HAZARDS Corrosive. Strong oxidizing agent. Do not use in concentrated form. Mix only with water in accordance with label instructions. Never bring concentrate in contact with other pesticides, cleaners or oxidative agents. PERSONAL PROTECTIVE EQUIPMENT (PPE) Applicators and handlers must wear coveralls over long-sleeved shirt, long pants, and chemical resistant footwear plus socks. When mixing and loading wear a chemical resistant apron. For overhead exposure wear chemical-resistant headgear. Wear protective eyewear (goggles, face shield, or safety glasses) and chemical resistant gloves. When cleaning equipment wear a chemical resistant apron. Follow manufacturer’s instructions for cleaning / maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry. Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this product. Do not reuse them. USER SAFETY RECOMMENDATIONS Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing. ENVIRONMENTAL HAZARDS This pesticide is toxic to birds and fish. For terrestrial uses: Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate. This product is highly toxic to bees and other pollinating insects exposed to direct contact on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees or other pollinating insects are actively visiting the treatment area. Do not apply this product or allow it to drift to crops where beneficials are part of an Integrated Pest Management strategy. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless 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 effluent containing 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. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. SaniDate£ 12.0 EPA Reg. No. 70299-18 Notification Label version (V11) Redline Copy January 3, 2017 Page 2 of 17 Do not apply this product through any irrigation system unless the chemigation instructions on this label are followed. Do not apply this product in a way that will contact workers or other persons, either directly or through drift. For any requirements specific to your state or tribe, consult the State or Tribal agency responsible for pesticide regulation. AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR Part 170. This standard contains requirements for the protection of agricultural workers on farms, forests, nurseries and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification and emergency assistance. It also contains specific instructions and exceptions pertaining to the statements on this label about Personal Protective Equipment (PPE) and Restricted-Entry Interval (REI). The requirements in this box apply to the uses of this product that are covered by the Worker Protection Standard. For enclosed environments: There is a restricted entry of one (1) hour for this product when applied via spraying to surfaces, equipment, structures and non-porous surfaces in enclosed glasshouses and greenhouses. PPE requirement for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil or water, is coveralls worn over long-sleeved shirt and pants, waterproof gloves and shoes plus socks. There is a restricted entry of zero (0) hours for pre-plant dip, seed treatment, soil drench, mop, sponge, dip, soak, rinse or other