crop-chem-docs/corpus/epa_ppls/264-964.md

RAXIL 2.6F SEED TREATMENT FUNGICIDE

• EPA Reg No: 264-964
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Tebuconazole (28.3%)
• Label accepted: 2010-10-22
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000264-00964-20101022.pdf

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! .~ .. , J .~ ) I j ',1. :; · (~ , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C. 20460 Mr. Melvin K. Tolliver Bayer CropSciehce LP PO,Box 12014,2 T.W. Alexander Drive, Research Triangle Park, NC 27709 OCT 2 2 2010 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Subject: Label Notification(s) for Pesticide Registration Notice 2001-5 Dear Registrant: The Agency is in receipt of your Application(s) for Pesticide Notification under Pesticide Registration Notice (PRN) 2001-5 dated September 27,2010 for: EPA Registration 264-964 Raxi12.6F Seed Treatment Fungicide The Registration Division (RD) has conducted a review of this request for applicability under PRN2001-5 and finds that the label change(s) requested falls within the scope of PRN-2001-5.The label has been date-stamped ''Notification'' and will be placed in our records. Please be reminded that 40 CFR PCirt 156. 140(a)(4) requires that a batch code, lot number, or other code identifying the batch of the pesticide distributed and sold be placed on nonrefillable containers. The code may appear either on the label (and can be added by non­ notificationlPR Notice 98-10) or durably marked on the container itself. If you have any questions, please contact me directly at 703-305-5335 or Banza Djapaoofmy staff at 703-305-7269. Sincerely, (!, Paul Mastradone, Acting Leader ~ Notifications & Minor FormulatioMTeam Leader Registration Division (7505P) Office of Pesticide Programs

PI.u.r.ad, on rev",.. before form. Eorm ADDroved, OMB No ... "~,, ........ __ XDir .. 2·28·95 United States Cl Registration OPP Identifier Number &EPA Environmental Protection Agency Amendment Washington. DC 20460 ./ Other Application for Pesticide - Section I

1. Company/Product Number 2. EPA Product Maneger 3. Proposed Classification 264·964 MaryWalller DNona D Rastricted
2. Company/Product (Name) PM' Raxil 2.6F Seed Treatment Fun~icide Team 21 S, Name and Addrass of Applicant (Include ZIP Code) 6. Expedited Reveiw. In accordance with FIFRA Section 3IcJ(3) Bayer CropScience LP (bJ(i), my product is similar or identical in composition and labeling P.O. Box 12014, 2 T.W. Alexander Drive to: N011F1CATION Research Triangle Park, NC 27709 EPA Reg. No. o Check if this is e new eddress Product Name OCT 2 2 2010 Section - II D Amendment· Explain below. U Final printed labels in repsonse to Agency letter dated D Resubmission in response to Agency letter dated D ·Me Too· Application. 0 Notification - Explain below. 0 Other - Explain balow. Explanation: Use additional page(sl if necessary. (For section I and Section 11.1 Notification to add resistance management per PR Notice 2001-5. See attached for explanation. Section - III
3. Material Thie Product Will Be Peckagad In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container Bves Bves B Ves r;] MM" No No Plastic No Glass • Certification must If ·Ves· No. par If ·Ves" No. per Paper Unit Packaging wgt. container Package wgt container Other (Specify) be submitttHI I
4. Location of Net Contents Informetion 4. Size(s) Retail Container IS' location of label Directions U label U Container B
5. Manner in Which Label is Affixed to Product oUthograPh D Othar Paper ~'ued Stanci itd Section - IV
6. Contact Point (Complete items directly be/ow for identificetion of individuel to be contected, if necessary, to process this application.) Name Title Talephone No. (Include Area Code) Melvin K. Tolliver Registration Product Manager, Fungicides (919) 549-2631 (..(..Ct, Certification 6. De\1/: ~ppliJation I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. Received L Cc I acknowledge that any knowlinglly false or misleeding statement mey be punisheble by fine or imprisonment or t. (S5'tIl,rI,ped) both under applicable law. e L l l , ,
7. Signature 3. Title t L L l I L L l L , I ~ K. ~ Registration Product Manager, Fungicides c II ll'_ (t \ t. L , , , t C l ' ,
8. Typed Name 5. Date l c L I. l I \ \ C , '" Melvin K. Tolliver Sepember 27,2010 C l. C <... (~ t C {'eLect. c . . ' . EPA Form 8570·1 (Rev. 3-941 PreVIous editions are obsolete. White • EPA FIle Copy longinen Ydot"l • Applcant Copy L c C C ( L

D~ L.(4 r-<lJ~ '- Bayer CropScience Document Processing Desk (NOTIF) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S4900 One Potomac Yard 2777 S. Crystal Drive Arlington, V A 22202 ( Subject: Raxill 2.6F Seed Treatment Fungicide, EPA Reg. No. 264-964 September 27,2010 Bayer Crop Science 2 T.W. Alexander Drive P. O. Box 12014 RTP, NC 27709 Phone: (919) 549-2000 Notification to Add a Resistance Management Language per PR Notice 2001-5 Dear Sir or Madam: The South Dakota Department of Agriculture requires registrants to add resistance management language per PR Notice 2001-5 to seed treatment labels before registering the product in South Dakota. Therefore, with the enclosed application form, we are notifying the Agency that we are adding the appropriate mode/target site of action classification and our own resistance management language as described under Section II of the enclosed EPA Form 8570-1. Since this is a notification, no PRIA fee is required. If you have any questions or need additional information, please contact me by phone at (919) 549-2631 or bye-mail atmel.tolliver@bayercropscience.com. Sincerely, Melvin K. Tolliver Registration Product Manager, Fungicides Enclosures:

1. EPA application form 8570-1 (. l C L C <.
2. Draft labeling, dated /09/24/2010 with changes highlighted in yellow c
3. Final Printed labeling (two copies) ( ( L C L ( ( (" c. c c t tee l (. L I. 9 <. t. <:.. { '. t ( « ~r ( C t.( L (. L , L ( L

( Rai12.6F Seed Treatment Fungicide EPA Reg. No. 264-964 Section IT - Continued The South Dakota Department of Agriculture requires registrants to add resistance management language per PR Notice 2001-5 to seed treatment labels before registering the product in South Dakota. Therefore, with this application form, we are notifying the Agency that we are adding the appropriate mode/target site of action classification to page 1 and our own resistance management language on page 4 of the attached draft labeling. As required for notifications we are enclosing one copy of draft labeling, dated 09/24/2010, in which the mode/target site of action classification and Bayer CropScience's resistance management language are highlighted in yellow. In addition, we are also enclosing two copies of final printed labeling. There are no changes in rates, timing of application, number of applications, or PHI from that which is currently registered. This notification is consistent with the provision ofPR Notice 2001-5 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.s.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 2001-5 and 40 CFR 152.46, this product may be in violation of FIFRA, and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA. l l l l l l t l L l.c L L l t· ( ~ (. L- t.: C L c <. c ( .. (, l '. l

( ( IHighlighted Copyl NOT~FICA1U,)N OCT 2 2 2010 I GROUP 11311 FUNGICIDE RAXIL ® 2.6 FSeed Treatment Fungicide FOR USE ONLY BY COMMERCIAL SEED TREATERS FOR CONTROL OF SPECIFIED DISEASES ON BARLEY, CORN, OATS, TRITICALE AND WHEAT ACTIVE INGREDIENTS: Tebuconazole, Alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1, 1-dimethyl-ethyl)-1 H-1 ,2,4-triazole-1-ethanol ...................... 2B.3% OTHER INGREDIENTS: ................................................................................................................................................ 71.7% Contains 2.6 Ibs. tebuconazole per gallon EPA Reg. No. 264 .. 964 EPA Est. STOP - READ THE LABEL BEFORE USE KEEP OUT OF REACH OF CHILDREN CAUTION TOTAL 100.0% For MEDICAL And TRANSPORTATION Emergencies ONLY Call 24 Hours A Day 1-800-334-7577 For PRODUCT USE Information Call1-866-99BAYER (1-866-992-2937) FIRST AID IF SWALLOWED: • Call a poison control center or doctor immediately for treatment advice. • Have person sip a glass of water if able to swallow. • Do not induce vomiting unless told to do so by poison control center or doctor. • Do not give anything by mouth to an unconscious person. IFON SKIN OR • Take off contaminated clothing. CLOTHING: • Rinse skin immediately with plenty of water for 15-20 minutes. • Call a poison control center or doctor for treatment advice. IFIN EYES: • 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. IF INHALED: • Move person to fresh air. • If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to- mouth if possible. • Call a poison control center or doctor for further treatment advice. 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 I. C t (, CAUTION <. (" ( ( HAZARDS TO HUMANS AND DOMESTIC ANIMALS l L L <- Harmful if swallowed, inhaled or absorbed through the skin. Avoid contact with skin, eyes and clothing. Avoid breathing vapdj' r spray mist. Wear long sleeved shirt, long pants or coveralls, and chemical-resistant gloves made of waterproof material. Remov9_ L , , L contaminated clothing and wash before reuse. Wash thoroughly with soap and water after handling. ~ I " II I I L l L l l t L L e l, c L (. l C (; C I.t

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c ENVIRONMENTAL HAZARDS This pesticide is toxic to mammals, 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. Runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate. Ground Water Advisory: Tebuconazole is known to leach through soil into ground 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 ground-water contamination. Surface Water Advisory: This product may contaminate water through drift of spray in wind. This product has a high potential for runoff for several months or more after application. Poorly draining soils and soils with shallow water tables are more prone to runoff that contains this product. A level, well maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential for contamination of water from rainfall-runoff. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted within 48 hours. DIRECTIONS FOR USE It Is a violation of Federal law to use this product In a manner Inconsistent with its labeling. Not for use on agricultural establishments in hopper-box, planter-box, slurry-box or other seed treatment applications at or immediately before planting. STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage and disposal. PESTICIDE STORAGE Store in a cool, dry place and in such a manner as to prevent cross contamination with other pestiCides, fertilizers, food, and feed. Store in original container and out of the reach of children, preferably in a locked storage area. PESTICIDE DISPOSAL Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. CONTAINER DISPOSAL Rigid, Non-refillable containers small enough to shake (Le., with capacities equal to or less than 5 gallons). Non-refillable container. Do not reuse or refill this container. Offer for recycling, if available. Triple rinse or pressure rinse container (or equivalent) promptly after emptying. 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. Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank and continue to drain for 10 seconds after the flow begins to drip. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip. Once container is rinsed, offer for recycling if available, or puncture and dispose of in a sanitary landfill or incineration, or if allowed by state and local authorities, by burning. If burned stay out of smoke. Rigid Non-refillable containers that are too large to shake (i.e., with capacities greater than 5 gallons or 50 Ibs) Non-refillable Containers Non-refillable containers - Do not reuse or refill this container. After emptying product from container, either return container to Bayer CropScience per instructions from Bayer CropScience Customer Service Center (1-800-527-4781), or rinse and either recycle or dispose of the container as follows: Bottom Discharge IBC (e.g. - Schuetz Caged IBC or Snyder Square Stackable) Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. To pressure rinse the container before final disposal, empty the remaining contents from the IBC into application equipment or mix tank. Raise the bottom of the IBC by 1.5 inches on the side which is opposite of the bottom discharge valve to promote more complete product removal. Completely remove the top lid of the IBC. Use water pressurized to at least 40 PSI to rinse all interior portions. Contim.louslY (pump or drain rinsate into application equipment or rinsate collection system while pressure rinsing. Continue pressure rinSing f&(2" fninutes or until rinsate becomes clear. Replace the lid and close bottom valve. Z L L C l C C (. Top Discharge IBC, Drums, Kegs (e.g.- Snyder 120 Next Gen, Bonar B120, Drums, and Kegs). L ( (l. " Triple rinsing the container before final disposal is the responsibility of the person disposing of the container. T0 tr1ol;"rinse the ~ container before final disposal, empty the remaining contents from this container into application equipment or mlx" t9.nk. Fill fh'e', ' ; container at least 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. 'Rim,e '.111 interior' ( surfaces. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this procedure two more ti~es. '- ( " ( , L I... . C L L C

r Once container is rinsed, offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration. Refillable Containers Refillable container. Refill this container with pesticide only. Do not reuse this container for any other purpose. After emptying product from container, either retum container to Bayer CropScience per instructions from Bayer CropScience Customer Service Center (1-800-527-4781) or rinse and either recycle or dispose of the container as follows: Bottom Discharge IBC (e.g. - Schuetz Caged IBC or Snyder Square Stackable) Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller. To pressure rinse the container before final disposal, empty the remaining contents from the IBC into application equipment or mix tank. Raise the bottom of the IBC by 1.5 inches on the side which is opposite of the bottom discharge valve to promote more complete product removal. Completely remove the top lid of the IBC. Use water pressurized to at least 40 PSI to rinse all interior portions. Continuously pump or drain rinsate into application equipment or rinsate collection system while pressure rinsing. Continue pressure rinsing for 2 minutes or until rinsate becomes clear. Replace the lid and close bottom valve. Top Discharge IBC, Drums, Kegs (e.g. - Snyder 120 Next Gen, Bonar B120, Drums, and Kegs). Triple rinSing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller. To triple rinse the containers before final disposal, empty the remaining contents from this container into application equipment or mix tank. Fill the container at least 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Rinse all interior surfaces. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this procedure two more times. Once container is rinsed, offer for recycling if available or puncture and dispose of in a sanitary landfill or by incineration. SEED LABELING REQUIREMENTS To meet U.S. Federal Seed Act reqUirements, all seed treated with RAXIL 2.6F must be labeled: "Treated with Tebuconazole (alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethyl-ethyl)-1 H-1,2,4-triazole-1-ethanol) (RAXIL). Do not use treated seed for feed, food or oil purposes. Barley, wheat and oat green forage may be grazed or harvested for hay 31 days after seeding." Resistance Management The component in Raxil 2.6F Seed Treatment Fungicide belongs to resistance group 3 (see resistance group number on front panel of label). Because resistance development cannot be predicted, the use of this product should conform to resistance management strategies established for the crop and use area. Such strategies may include rotating and/or tank mixing with products having different modes of action; or limiting the total number of applications per season. Use labeled rates. Contact your local extension speCialist, certified crop advisor, and/or manufacturer for fungicide/insecticide resistance management and/or integrated pest management recommendations for specific crops and pest populations. Bayer CropScience encourages responsible product stewardship to ensure effective long-term control of pests on this label. RAXIL controls or suppresses certain designated seed and soilborne diseases of barley, corn, oats, triticale and wheat. SEED TREATMENT: Apply RAXIL 2.6F as a water-based slurry through standard slurry or mist-type commercial seed treatment equipment. Prepare a slurry by mixing the specified dosage in 9 to 20 fI oz of water per 100 Ibs of seed. Add dye" to the resulting slurry. Mix the slurry thoroughly with the seeds to provide uniform coverage. **21 CFR Chapter I, Section 2.25 requires grain seed treated with poisonous substances in excess of recognized tolerances be suitably colored with an EPA approved dye, such as one of the dyes listed in 40 CFR Section 180.1001 (c) and (d), to prevent their subsequent inadvertent use as a food for man or feed for animals. <. L L C t. I C <. L L C L C Lt. C( l Let ( \ C l L L (.' C •• C L l L L I L <­ l (.4 ul.:" c:

( CORN (SWEET CORN, FIELD CORN, FIELD CORN GROWN FOR SEED, AND POPCORN) DISEASE RATE n oz/100 Ibs OF SEED Soilborne and Seedborne Fusarium 0.075 -0.1 Soilborne and Seedborne Head smut 0.37-0.74 (Sphacelotheca reiliana) APPLICATION RATE CROP & DISEASE RATE OF RAXIL 2.6F Wheat and Triticale: 0.1 fl ozl100 Ibs of seed Stinking Smut, Flag Smut, Loose Smut, Early Season Septoria Disease Complex, Early Season Rhizoctonia Root Rot, Early Season Common Root Rot, Early Season Fusarium Foot Rot, Early Season, Suppression of Powdery Mildew, Early Season Suppression of Wheat Leaf Rust Barley: Covered Smut, Loose Smut, Barley Stripe (suppression), Early Season Rhizoctonia Root Rot, Early Season Common Root Rot, Early Season Fusarium Foot Rot, Early Season Suppression of Powdery Mildew, Early Season Suppression of Barley Leaf Rust Oats: Loose Smut, Pythiurn Damping-off, Early Season Rhizoctonia Root Rot, Early Season Common Root Rot, Early Season Fusarium Foot Rot, Early Season Suppression of Powdery Mildew, Early Season Suppression of Crown Rust Refillable Containers DIRECTIONS FOR USE Apply as a seed treatment using standard slurry or mist-type seed treatment equipment. Uniform application of seed is necessary to ensure seed safety and best disease protection. Seed should be sound and well cured prior to treatment. Product should be diluted with sufficient water ensure complete seed coverage. Add dye to the resulting slurry. Consult a seed treatment specialist regarding slurry rates recommended for the crop to be treated with RAXIL 2.6F. The length of control will vary depending on the rate used. APPLICATION DIRECTIONS Refer to the SEED TREATMENT section on this label for the specified method of treating seed. End users are authorized to remove tamper evident cables as required to remove the product from the container unless the container is equipped with one way valves and refilling or returning is planned. If this is the case, end users are not authorized to remove tamper evident cables, one way valves or clean container. See Container Disposal instructions under Storage and Disposal. c· II (. l, L t. L L C l., (, C C l

,- 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, retum 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, 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. To the extent allowable under State law, all such risks shall be assumed by the user or buyer. DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, BAYER CROPSCIENCE 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 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 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'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: RAXIL is a registered trademark of Bayer Produced for ffi Bayer Crop Science Bayer CropScience LP P.O. Box 12014, 2 T.W. Alexander Drive Research Triangle Park, North Carolina 27709 1-866-99BA YER (1-866-992-2937) I. '- L l. l ( 9 g RAXIL 2.6F Seed Treatment (MASTER) Approved 03/25/10 NOTIFICATION 09/24/2010 L l ( '. t L , '- '-