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US EPA, Pesticide Product Label, VBC -60397,02/10/2015

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US EPA, Pesticide Product Label, VBC -60397,02/10/2015 U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date of Issuance: Office of Pesticide Programs Biopesticides and Pollution Prevention Division (7511P) 73049-502 2/10/2015 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 NOTICE OF PESTICIDE: Term of Issuance: X Registration Reregistration Unconditional (under FIFRA, as amended) Name of Pesticide Product: Sympatico Biological Insecticide Emulsifiable Suspension Name and Address of Registrant (include ZIP Code): Valent Biosciences Corporation 870 Technology Way, Suite 100 Libertyville, IL 60048 Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Biopesticides and Pollution Prevention Division prior to use of the label in commerce. In any correspondence on this product, always refer to the above EPA Registration Number. On the basis of information furnished by the registrant, the above named pesticide is hereby registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act). Registration is in no way to be construed as an endorsement or recommendation of this product by the U.S. Environmental Protection Agency (EPA). In order to protect health and the environment, the Administrator, on his or her motion, may at any time suspend or cancel the registration of a pesticide in accordance with the Act. The acceptance of any name in connection with the registration of a product under the Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if it has been covered by others. This product is unconditionally registered in accordance with FIFRA section 3(c)(5) provided that you: 1. Submit and/or cite all data required for registration or registration review of your product when the EPA requires all registrants of similar products to submit such data. 2. Submit storage stability and corrosion characteristics (Guidelines 830.6317 and 830.6320) data as these data requirements are not satisfied. A one-year study is required to satisfy these data requirements. You have 18 months from the date of this registration to provide these data to the EPA. Signature of Approving Official: Date: 2/10/2015 Shannon Borges, Team Leader Microbial Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs EPA Form 8570-6 Page 2 of 2 EPA Reg. No. 73049-502 OPP Decision No. 492991 3. Make the following labeling change before you release this product for shipment: Revise the EPA Registration Number to read, “EPA Reg. No. 73049-502.” 4. Submit one (1) copy of the final printed labeling for the record before you release this product for shipment. Should you wish to add/retain a reference to your company’s website on your label, then please be aware that the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or misleading, the product will be considered to be misbranded and sale or distribution of the product is unlawful under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements the 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 EPA 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 Assurance. Your release for shipment of this product constitutes acceptance of these terms. If these terms are not complied with, this registration will be subject to cancellation in accordance with FIFRA section 6. A stamped copy of the labeling is enclosed for your records. Please also note that the record for this product currently contains the following acceptable Confidential Statement of Formula (CSF): Basic CSF dated 01/19/2015. Any CSFs other than the one listed above are superseded. If you have any questions, please contact Michael Glikes of my team by phone at (703) 305-6231 or via email at [email protected]. Sincerely, Shannon Borges, Team Leader Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs Enclosure 02/10/2015 SYMPATICO BIOLOGICAL INSECTICIDE EMULSIFIABLE SUSPENSION 73049-502 BIOFUSED Active Ingredient: Bacillus thuringiensis, subsp. kurstaki, strain VBTS-2546, fermentation solids, spores, and insecticidal toxins.................................................................................................... 15.6% Bacillus thuringiensis, subsp. aizawai, strain ABTS-1857, fermentation solids, spores and insecticidal toxins……………………………………………………………………… 10.4% Other Ingredients................................................................................................................74.0% Total.................................................................................................................................100.0% KEEP OUT OF REACH OF CHILDREN CAUTION Manufactured For: Valent BioSciences Corporation 870 Technology Way Libertyville, IL 60048 EPA Registration No.: 73049-XXX Batch Code: __________ EPA Est. No.: Net Weight: FIRST AID If on skin or y Take off contaminate clothing. clothing y Rinse skin immediately with plenty of water for 15 - 20 minutes. y Call a poison control center or doctor for treatment advice If in eyes y Hold eyes open and rinse slowly and gently with water for 15 - 20 minutes. y Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. y Call a poison control center or doctor for treatment advice. HOTLINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-892-0099 (24 hours) for emergency medical treatment and/or transport emergency information. For all other information, call 1-800-6- Valent. NOTE TO PHYSICIAN Contains petroleum distillate - vomiting may cause aspiration pneumonia. VBC-60397 June 27, 2014 Page 1 of 29 PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) CAUTION Harmful if absorbed through the skin. Avoid contact with skin, eyes, or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Personal Protective Equipment Some materials that are chemical-resistant to this product are listed below. If you want more options, follow the instructions for category E on an EPA chemical resistance category selection chart. Applicators and other handlers must wear: x Long-sleeved shirt and long pants. x Chemical-resistant gloves, such as barrier laminate, or nitrile rubber, or neoprene rubber or viton. x Shoes plus socks. Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables, use detergent and hot water. Keep and wash PPE separately from other laundry. Agricultural Use Requirements: Mixers/loaders and applicators must wear a dust/mist filtering respirator meeting NIOSH standards of at least N-95, R-95, or P-95. Repeated exposure to high concentrations of microbial proteins can cause allergic sensitization. When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS. IMPORTANT: When reduced PPE is worn because a closed system is being used, handlers must be provided all PPE specified above for “mixers/loaders and applicators” and have such PPE immediately available for use in an emergency, such as a spill or equipment breakdown. VBC-60397 June 27, 2014 Page 2 of 29 USER SAFETY RECOMMENDATIONS Users should: y 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. y Remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. ENVIRONMENTAL HAZARDS Do not apply directly to water, or to where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing of equipment washwaters. This product must not be applied aerially within ¼ mile of any habitats of endangered species or threatened Lepidoptera. No manual application can be made within 300 feet of any threatened or endangered Lepidoptera. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. For any requirements specific to your State or Tribe, consult the agency responsible for pesticide regulation. VBC-60397 June 27, 2014 Page 3 of 29 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),
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