US EPA, Pesticide Product Label, ONAGER EW MITICIDE,08/30/2019
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION August 30, 2019 Ms. Kyla S. Smith Registration Specialist Gowan Company P.O. Box 5569 Yuma, AZ 85366-5569 Subject: PRIA Label Amendment – Addition of Low Growing Berry Subgroup 13-07G Product Name: ONAGER EW MITICIDE EPA Registration Number: 10163-337 Application Date: March 15, 2018 Decision Number: 539557 Dear Ms. Smith: The application referred to above, submitted under the Federal Insecticide, Fungicide and Rodenticide Act, as amended is acceptable under FIFRA sec 3 (c)(5). You must submit and/or cite all data required for registration/reregistration/registration review of your product when the Agency requires all registrants of similar products to submit such data. A stamped copy of your labeling is attached for your records. This labeling supersedes all previously accepted labeling. You must submit one (1) copy of the final printed labeling before you release 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 months from the date of this letter. After 18 months, you may only distribute or sell this product if it bears this new revised labeling or subsequently approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg) and its implementing regulation at 40 CFR 152.3. 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. Fast Track Label Acceptable v.20150320 Page 2 of 2 EPA Reg. No. 10163-337 Decision No. 539557 Your release for shipment of the product constitutes acceptance of these conditions. If you fail to satisfy these data requirements, EPA will consider appropriate regulatory action including, among other things, cancellation under FIFRA section 6(e). If you have any questions, please contact Mr. Carmen J. Rodia, Jr. by phone at (703) 306-0327, or via email at [email protected]. Sincerely, For: Marion J. Johnson, Jr., Acting Product Manager 10 Invertebrate & Vertebrate Branch 2 Registration Division (7505P) Attachments: Stamped “Accepted” Master & Supplemental Labels, dated August 30, 2019 EFED Drinking Water Assessment, dated June 6, 2019 EFED Risk Assessment, dated August 28, 2019 HED Risk Assessment, dated July 2, 2019 HED Summary of Analytical Chemistry and Residue Data, July 2, 2019 Page 1 of 9 HEXYTHIAZOX GROUP 10A ACARICIDE ONAGER EW MITICIDE [Alternate Brand Name: ONAGER OPTEK MITICIDE] EMULSION FOR AGRICULTURAL USE ONLY ACTIVE INGREDIENT: Hexythiazox % By Wt. trans-5-(4-Chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide*…………………………………….11.93% OTHER INGREDIENTS**………………...………………………………………………………………………………………….88.07% TOTAL 100.00% *Onager EW contains 1.0 lb. active ingredient per gallon **Contains Petroleum Distillate KEEP OUT OF REACH OF CHILDREN CAUTION FIRST AID If swallowed x Call a poison control center or doctor immediately for treatment advice. x Do not induce vomiting unless told to do so by the poison control center or doctor. x Do not give any liquid to the person. x Do not give anything by mouth to an unconscious person. 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. 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 by mouth-to-mouth, if possible. x Call a poison control center or doctor for further treatment advice. If on skin or clothing x Take off contaminated clothing. x Rinse skin immediately with plenty of water for 15-20 minutes. x Call a poison control center or doctor for treatment advice. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For non- emergency general information on this pesticide product (including health concerns, medical emergencies or pesticide incidents), you may call 1-888-478-0798, 24 hours per day, 7 days per week. NOTE TO PHYSICIAN Contains petroleum distillate. May pose an aspiration pneumonia hazard. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION Harmful if swallowed, inhaled or absorbed through skin. Causes moderate eye irritation. Avoid contact with skin, eyes, or clothing. Avoid breathing vapor or spray mist. Wash hands thoroughly with 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. NET CONTENTS ____ 08/30/2019 10163-337 Produced For: Gowan Company EPA Reg. No. 10163-337 P.O. Box 5569 EPA Est. No. 67545-AZ-01 Yuma, AZ 85366 Page 2 of 9 PERSONAL PROTECTIVE EQUIPMENT (PPE) Applicators and other handlers must wear: x Long-sleeved shirt and long pants x Chemical-resistant gloves made of barrier laminate, nitrile rubber ≥ 14mils, neoprene rubber ≥ 14mils, or viton ≥ 14mils x Shoes plus socks Remove and wash contaminated clothing before reuse. 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. USER SAFETY RECOMMENDATIONS Users should: x Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. x Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. x Users should 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 fish and aquatic invertebrates. Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Drift and runoff from treated areas may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when cleaning equipment or when disposing of equipment washwaters. PHYSICAL OR CHEMICAL HAZARDS Do not use, pour, spill or store near heat or open flame. PRODUCT INFORMATION Onager EW Miticide is recommended for use as a foliar application in labeled crops. Onager EW Miticide provides effective control of Tetranychid spider mite species. It is an emulsion to be mixed with water and applied as a spray. Onager EW controls mites through activity on eggs and immature stages. Control is achieved from either direct contact with the spray or from contact with treated plant surfaces. Through its ovicidal activity, Onager EW controls newly deposited mite eggs and eggs which are laid after application. Onager EW is also highly effective in controlling immature motile stages of target mite species that are sprayed or move onto treated surfaces. Adult mites are not directly affected. However, eggs produced by females in contact with treated surfaces will be rendered nonviable. Onager EW provides residual control of pest mite species. The degree and duration of control is dependent on the rate used, growth stage of the mite, species of mite, and climatic conditions under which the material is applied. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application. For any requirements specific to your State or Tribe, consult the agency responsible for pesticide regulation. USE RESTRICTIONS ON ALL CROPS x Apply this product as specified on the EPA approved label and any supplemental labeling. x Onager EW is an emulsion to be diluted with water for application in commercial plantings only. x Apply Onager EW prior to adult mite build up. Onager EW will not control adult spider mites. Use higher rates on moderate-to-high mite infestations or for larger plants with a dense canopy. If adult mites are present in medium-to-high populations, better results may be obtained using Onager EW in combination with a registered contact adulticide. The use of less than label rates is not recommended with Onager EW. x Do not make more than one application of Onager EW or any other hexythiazox product to the same crop per year. x Do not plant rotational crops other than those on this label within 120 days of this application. 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 intervals.