crop-chem-docs/corpus/epa_ppls/264-955.md

RAXIL THIRAM FLOWABLE FUNGICIDE

• EPA Reg No: 264-955
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Thiram (20%); Tebuconazole (0.6%)
• Label accepted: 2009-05-28
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000264-00955-20090528.pdf

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r U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide Programs Registration Division (7505C) 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 NOTICE OF PESTICIDE: Registration XX Reregistration (under FIFRA, as amended) EPA Reg. Number: 264-955 Date of Issuance: MAY 2 8 2009 Terms of Issuance: Conditional Name of Pesticide Product: Raxil Thiram Flowable Fungicide Name and Address of Registrant (include ZIP Code): Bayer CropScience LP P.O. Box 12014, 2 T.W. Alexander Drive Research Triangle Park, NC 27709 Attn: Fred C. Rosa Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Registration 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 reregistered under the Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect health and the environment, the Administrator, on his 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 this 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. Based on your response to the Reregistration Eligibility Document(s), EPA has reregistered the product listed above. Enclosed is a copy of your label stamped "Accepted with comments." This action is taken under the authority of section 4(g)(2)(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. Reregistration under this section does not eliminate the need for continual reassessment of pesticides. EPA may require submission of data at any time to maintain the registration of your product. Signature of Approving Official: [A. Shaja Jipyner, Product Manager Team 20 Fungicide Branch Registration Division (7505P) Date: MAY 2 8 2009 EPA Form 8570-6

EPA Reg. No. 264-955 Submit one copy of your final printed labels, with the changes herein, before you release the product for shipment.

1. The Agency is not authorized to regulate sales. Please revise statement to read, ".Intended for use by professional applicators only."
2. In the email dated April 23, 2009 we asked that you make the following correction to page 2 in the PPE section, add an "s" to "loader" in the subheading "All mixers/loaders, applicators and other handlers must wear" In addition, remove the period after mixing in the chemical resistant gloves statement. .
3. On page 2 in the PPE section change "category E" to "category F."
4. In the email dated April 23, 2009 we asked that you add the following to page 2, in the Environmental Hazards section, you must add the following Ground language: "Ground Water Advisory: Tebuconazole is known to leach through soil into ground water under certain conditions as a result of label use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in groundwater contamination.
5. In the email dated April 23, 2009, we asked that you add statements to the Seed Labeling section. The following two bullets were omitted: Dispose of all excess treated seed by burying seed away from bodies of water. Dispose of seed packaging or containers in accordance with local requirements.
6. On page 3 in the Seed Labeling section, bullet 5, the following sentence was omitted: "Cover or collect treated seeds spilled during planting. The one-year, room temperature Storage Stability and Corrosion Characteristics data are still outstanding for this product. If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA sec.6(E). Your release for shipment of the product constitutes acceptance of these conditions. l Enclosures: Product Reregistration Branch Review (dated February 20, 2009) Acute Toxicity Review (dated January 5, 2009) Product Chemistry Review (dated February 19, 2009)

RAXIL r FBowabSe Fungicide For sale to and use by professional applicators only. Not for sale to or use by homeowners/consumers. _ _ _ ACTIVE INGREDIENTS: Tebuconazole(Alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethyl-ethyl)-1H-1,2,4-triazole-1-ethanol) ........................ 0.6% Thiram (Tetramethylthiuram disulfide) ....................................................................................................................... '.....20.0% INERT INGREDIENTS*: ..... ........................................................................................................................................... 79.4% TOTAL 100.0% 'Contains petroleum distillates Contains 0.055 pounds Alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethyl-ethyl)-1H-1,2,4-triazole-1-ethanol.and 1.84 pounds Thiram per U.S. gallon. _ _ EPA Reg. No. 264-955 EPA Est. KEEP OUT OF REACH OF CHILDREN CAUTION For MEDICAL And TRANSPORTATION Emergencies ONLY Call 24 Hours A Day 1-800-334-7577 For PRODUCT USE Information Call 1-866-99BAYER (1-866-992-2937) FIRST AID IF SWALLOWED: IF ON SKIN OR CLOTHING: IF IN EYES: IF INHALED • o e o • 0 o Immediately call a poison control center or doctor. Do not induce vomiting unless told to do so by a poison control center or doctor. Do not give any liquid to the person. Do not give anythingjjy mouth to an unconscious person. Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Call a poison control center or doctor for treatment advice. • Hold eye open and rinse slowly and gently with water for 15-20 minutes.- • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. « Call a poison control center or doctor for treatment advice. o • • Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration mouth if possible. Call a poison control center or doctor for treatment advice. preferably mouth-to- NOTE TO PHYSICIAN: Contains petroleum distillate -may pose aspiration pneumonia hazard. In case of emergency call toll free the Bayer CropScience Emergency Response Telephone No. 1-800-334-7577. Have a product container or label with you when calling a poison control center or doctor, or going for treatment. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION Harmful if swallowed. Harmful if absorbed through skin. Harmful if inhaled- Causes moderate eye irritation. Avoid contact with eyes, skin, or clothing. Avoid breathing spray mist or vapor. ACCEPTED with COMMENTS bt EPA LsttM- JSJatod aed aa amended, far Page 1 of 5

f PERSONAL PROTECTIVE EQUIPMENT (PPE) Some materials that are chemical-resistant to this product are barrier laminate or nitrile rubber or neoprene rubber or neoprene rubber viton. If you want more options, follow the instructions for category E on an EPA chemical resistance category selection chart. All mixers/loader, applicators and other handlers must wear: Long-sleeved shirt and long pants, shoes plus socks, chemical-resistant gloves, chemical resistant apron when mixing., loading, cleaning up spills, cleaning equipment, or otherwise exposed to the concentrate. NOTE: Persons involved in bagging treated seed, sewing or moving bags of treated seed, or cleaning up bagging areas or seed treatment equipment are pesticide handlers and must wear the PPE required on this label for pesticide handlers. USER SAFETY REQUIREMENTS 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. USER SAFETY RECOMMENDATIONS Users should wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. 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. ENDANGERED SPECIES This bag contains seed treated with thiram and tebuconazole. This product may have effects on federally listed threatened endangered species or their critical habitat in some counties. It is a violation of federal law to kill, harm or harass listed animal species without authorization. To limit the potential for such impacts when using this product, consult and follow the instructions provided in the EPA Endangered Species Bulletin for the County or Parish in which you are applying the seed. To determine whether your County or Parish has a Bulletin consult http://www.epa.gov/espp before each season's use of this product. ENVIRONMENTAL HAZARDS This pesticide product is toxic to fish, aquatic vertebrates, oysters and shrimp. Drift or runoff from treated areas may be hazardous to aquatic organisms in neighboring areas. 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 washwaters. Treated seeds are hazardous to fish, birds and mammals. Do not plant treated seeds by broadcasting to the soil surface. Ensure that all seeds are thoroughly covered with soil, especially in turn areas. If seeds are not thoroughly incorporated by the planter during planting, additional incorporation may be required to thoroughly cover exposed seeds. Page 2 of 5

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. 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. STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage, disposal or by cleaning of equipment. PESTICIDE STORAGE Store in a cool, dry place. PESTICIDE DISPOSAL Pesticide wastes are toxia Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL Rigid, Non-refillable containers small enough to shake (i.e., with capacities equal to or less than 5 gallons) Non-refillable container. Do not reuse or refill this container. Clean container promptly after emptying. Contact Bayer CropScience or your chemical supplier for container return instructions. If container- is not returned in accordance with instructions, triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. ,.(Fill the container 1/4 full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store 'rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times. Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or if allowed by state and local authorities, by burning. If burned, stay out of smoke. (Intermediate Bulk containers 50 and 200 gallons) Non-refillable container. Do not reuse or refill this container. After emptying product from container, contact Bayer CropScience Customer Service Center (1-800-527-4781) with return authorization for container return instructions. Cleaning the container before final disposal is the responsibility of the person disposing of the container. Once container is rinsed, offer for recycling, if available, or dispose of in a sanitary landfill or by incineration, or if allowed by state and local authorities, by burning. If burned stay out of smoke. 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. The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard. Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 24 hours. Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard allows workers to enter the treated area with out restriction if there will be no worker contact with the seeds, bulbs, seed pieces. PPE required 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, chemical-resistant gloves made of any waterproof material, shoes plus socks and protective eyewear. SEED LABELING Seed that are treated with this product and are then packaged or bagged for future use by growers or researchers must contain the1 following labeling on the outside of the seed package or bag: To meet U.S. Federal Seed Act requirements, all seed treated with RAXIL-Thiram Flowable Fungicide should be labeled: • TREATED SEED « Treated with Alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol (tebuconazole) and Tetramethylthiuram disulfide (Thiram). • Store treated seed away from food and feedstuffs. • Do not allow children, pets or livestock to have access to treated seeds. • Treated seeds exposed on soil surface may be hazardous to wildlife. • DO NOT USE FOR FOOD, FEED OR OIL PURPOSES. • Barley, wheat, oat and triticale green forage may be grazed or harvested for hay 31 days after seeding. • This bag contains seeds treated with thiram and tebuconazole fungicides. When opening this bag or loading/pouring the treated seeds wear long-sleeved shirt, long pants, shoes, socks and chemical resistant gloves. • Endangered Species section of this label must be included on the seed tag. • After the seeds have been planted, do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 24 hours. Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard allows workers to ' enter the treated area with out restriction if there will be no worker contact with the seeds. 0 „ . _ • Page 3 of 5

r 1 » Treated seeds are hazardous to fish, birds and mammals. Do not plant treated seeds by broadcasting to the soil surface. Ensure that all seeds are thoroughly covered with soil, especially in turn areas. If seeds are not thoroughly incorporated by the planter during planting, additional incorporation may be required to thoroughly cover exposed seeds. 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 cleaning equipment or disposing of equipment wash waters or rinsate. . • Plant wheat, barley and oat seed a minimum of 1 inch deep. RAXIL-Thiram Flowable Fungicide combines the systemic action of RAXIL with the surface action of Thiram and Tebuconazole to control or suppress various seed, seedling and soilborne diseases of wheat, barley, oats and triticale. RESTRICTIONS Do not use treated seed for feed, food or oil purposes. Seed labeling must contain the following restriction: Barley, wheat, oat and triticale green forage may be grazed or harvested for hay 31 days after seeding. Barley Seed: Plant barley seed a minimum of 1 inch deep. Oat Seed: Plant oat seed a minimum of 1 inch deep. Wheat Seed: Plant wheat seed a minimum of 1 inch deep. APPLICATION RATE CROP & DISEASE Seed and Soilborne Diseases: FLUID OUNCES RAXIL-Thiram Flowable Fungicide APPLICATION DIRECTIONS Wheat, Triticale: Stinking smut, Flag Smut, Loose Smut, Early Season Septoria Disease Complex, general seed rots, Pythium Damping-off, Early Season Rhizoctonia Root Rot, Early Season Common root rot, Seedborne Fusarium Scab, Early Season Fusarium ' Foot Rot, Early Season Suppression of Powdery Mildew, Early Season Suppression of Leaf Rust Barley: Covered Smut, Loose Smut, Barley Stripe (suppression), general seed rots, Pythium Damping-Off, Early Season Rhizoctonia Root Rot, Seedborne Fusarium Scab, Early Season Fusarium Foot Rot Early Season Suppression of Powdery Mildew, .Early Season Suppression of Barley Leaf Rust Oats: Loose Smut, general seed rots, Pythium Damping-Off, Early Season Rhizoctonia Root rot, Early Season Common Root Rot, Seedborne Fusarium Scab, Early Season Fusarium Foot Rot, Early Season Suppression of Powdery Mildew, Early Season Suppression of Crown Rust 3.5 to 4.6 fluid ounces per 100 pounds of seed SEED TREATMENT! Application of RAXIL-Thiram Flowable Fungicide at the specified rate per 100 pounds of seed must be made using standard slurry or mist-type seed treatment equipment. Uniform application to seed is necessary to ensure seed safety and best disease protection. Seed must be sound and well cured prior to treatment. Product must be diluted with sufficient water to give an applied slurry rate of 9 to 20 fl oz per 100 pounds of seed. Use low rate under dryland or low rainfall conditions and consult your area agronomist regarding planting depth specifications for the particular variety to be planted. Page 4 of 5

f. r 11 IMPORTANT: READ BEFORE USE Read the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations of Liability before using this product. If terms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Conditions, disclaimer of Warranties and Limitations of Liability. Treatment of highly mechanically damaged seed, or seed of known low vigor and poor quality, may result in reduced germination and/or reduction of seed and seedling vigor. Treat and conduct germination tests on a small portion of seed before committing the total seed lot to a selected chemical treatment. Due to seed quality conditions beyond the control of Bayer CropScience LP, no claims are made to guarantee germination of carry-over seed. CONDITIONS: The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as weather conditions, presence of other materials, or the manner of use or application, all of which are beyond the control of Bayer CropScience LP. All such risks shall be assumed by the user or buyer. DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, BAYER CROPSCIENCE LP MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Bayer CropScience LP is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, BAYER CROPSCIENCE LP DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT BAYER CROPSCIENCE LP'S ELECTION, THE REPLACEMENT OF PRODUCT. NOTICE TO BUYER Purchase of this material does not confer any rights under patents governing this product or the use thereof in countries outside of the United States. NET CONTENTS: gallons RAXIL is a registered trademark of Bayer Produced for av , -Rj Baye r C ropSc i e nee Bayer CropScience LP P.O. Box 12014, 2 T.W. Alexander Drive Research Triangle Park, North Carolina 27709 1-866-99BAYER (1-866-992-2937) RAXIL-Thiram Flowable Fungicide (PENDING) 01/31/08, resubmit 05/04/09 Page 5 of 5