crop-chem-docs/corpus/epa_ppls/264-967.md

RAXIL ALLEGIANCE MD FUNGICIDE

• EPA Reg No: 264-967
• Registrant: BAYER CROPSCIENCE, LLC
• Signal word: Caution
• Active ingredients: Metalaxyl (0.64%); Tebuconazole (0.48%)
• Label accepted: 2011-09-21
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000264-00967-20110921.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL, SAFETY AND POLLUTION PREVENTION Melvin K. Tolliver Bayer CropScience LP P.O. Box 12014 SEP 2 1 2011 2 T.W. Alexander Drive Research Triangle Park, NC 27709 Product Name: Raxil Allegiance MD Fungicide EPA Reg. No.: 264-967 Subject: Application for Pesticide Notification dated 7/15/11 EPA Decision Number: 452149 Dear Mr. Tolliver: The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10. The Registration Division (RD) has conducted a review of this request for its applicability under PRN 98-10 and finds that the action(s) requested fall within the scope of PRN 98-10. The Agency acknowledges the deletion of the Notice to Buyer statement. The label submitted with the application has been stamped "Notification" and will be placed in our records. If you have questions concerning this letter, please contact Erin Malone at 703-347-0253 or via email at malone.erin@epa.gov. Sincerely, Mary Waller Product Manager 21 Fungicide Branch Registration Division (7504P) Office of Pesticide Programs

Please red instruction on nvene before completing form. Form Approved. OMB No. 2070-OO6O. Aooroval exoires 2-28-95 v>EPA United States Environmental Protection Agency Washington, DC 20460 Registration Amendment Other OPP Identifier Number Application for Pesticide - Section I

1. Company/Product Number 264-967
2. Company/Product (Name) Raxil Allegiance MD Fungicide
3. EPA Product Manager Mary Waller PMf Team 21
4. Proposed Classification None Restricted
5. Name and Address of Applicant (Include ZIP Code) Bayer CropScience LP P.O. Box 12014, 2 T.W. Alexander Drive ResearchJTriangle Park, NC 27709 Check if this is a new address
6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3) (b)(i), my product is similar or identical in composition and labeling to: EPA Reg. No. Product Name Section - II Amendment - Explain below. Resubmission in response to Agency letter dated. Notification - Explain below. Final printed labels in repsonse to Agency letter dated "Me Too" Application. Other - Explain below. Explanation: Use additional page(s) if necessary. (For section I and Section II.) Notification to remove a non-FIFRA label element per PR Notice 98-10. See attached for explanation. Section - III
7. Material This Product Will Be Packaged In: Child-Resistant Packaging I Yes No

• Certification must be submitted If "Yes" No. per Unit Packaging wgt. container Water Soluble Packaging Yes No If "Yes" Package wgt No. per container

2. Type of Container Metal Plastic Glass Paper Other (Specify)
3. Location of Net Contents Information Label Container
4. Size(s) Retail Container 5. Location of Label Directions bd
5. Manner in Which Label is Affixed to Product Lithograph Paper glued Stenciled || Other Section - IV
6. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.) Name Melvin K. Tolliver Title Registration Product Manager, Fungicides Telephone No. (Include Area Code) (919)549-2631" C\ L<- C c I- C I. i (. Certification ! ' '« I certify that the statements I have made on this form and all attachments thereto are true, accurate and conv>i9»e,, , I acknowledge that any knowlinglly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
7. Signature
8. Typed Name Melvin K. Tolliver
9. Title Registration Product Manager, Fungicides
10. Date July 15, 2011
11. Date Application Rcieivec' ' (Stamped) EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete. White - EPA File Copy (original! Yellow - Applicant Copy

Raxil Allegiance MD Fungicide EPA Reg. No. 264-967 Section II - Continued Raxil Allegiance MD Fungicide is currently registered as a seed treatment. With the enclosed annotated draft label and two copies of final printed label we are notifying the Agency of our desire to remove the following "Notice to Buyer" statement from our label as indicated by the red strikethroughs on the last page of the annotated draft label. "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." Since this is a non-FIFRA related label element and there are no patent numbers on the label, we believe that this notification complies with PR Notice 98-10. This notification is consistent with the provision of PR Notice 98-10 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 98-10 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.

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, VA 22202 July 15, 2011 Bayer CropScience 2 T.W. Alexander Drive P. O. Box 12014 RTF, NC 27709 Phone:(919)549-2000 Subject: Raxil Allegiance MD Fungicide, EPA Reg. No. 264-967 Notification to Remove Notice Regarding Patent Dear Sir or Madam: With the enclosed application form we are notifying the Agency of our desire to remove a notice to buyer statement on our label regarding patent numbers. Since this is a non-FIFRA related label element and no patent numbers appear on our label, we believe that this notification complies with PR Notice 98-10 and no PRIA fee is required. If you have any questions or need additional information, please contact me by phone at (919) 549-263 1 or by e-mail at mel.tolliver(g),baver.com. Sincerely, Melvin K. Tolliver Registration Product Manager, Fungicides Enclosures: 1 . EPA application form 8570- 1 2. Draft annotated labeling, dated 07/15/201 1 3. Final Printed labeling (two copies)

NOTIFICATION SEP 2 t 2011 RAXIL® ALLEGIANCE® MDFungicide _ ACTIVE INGREDIENTS: Tebuconazole: Alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethyl-ethyl)-1H-1,2,4-triazole-1-ethanol ...................... 0.48% Metalaxyl: N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine methyl ester .................................................................. 0.64% OTHER INGREDIENTS: .............................................................................................................................................. 98.88% TOTAL 100.00% Contains 0.039 pounds Tebuconazole and 0.051 pounds Metalaxyl per U.S. gallon. _ _ EPA Reg. No. 264-967 _ EPA Est. _ KEEP OUT OF REACH OF CHILDREN CAUTION_ See Additional Precautionary Statements _ 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) 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 PERSONAL PROTECTIVE EQUIPMENT (PPE) Applicators and other handlers must wear: Long-sleeved shirt, long pants, and 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. USER SAFETY RECOMMENDATIONS Users should: Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothes. 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 highly toxic to fish, estuarine and marine 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. Do not contaminate water when disposing of equipment washwaters. Cover or incorporate spilled treated seeds. Groundwater Advisory: Metalaxyl and Tebuconazole are known to leach through soil into groundwater under certain conditions as a result of agricultural use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in groundwater contamination. Surface Water Advisory: This product has a high potential for runoff for several months or more after applicstion. Poorly drawing 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 applicatidiis'^nen rain.'all is'fc/recasted within 48 hours. 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 pK>ifccit,(* handlers may be in the area during application. For any requirements specific to your State or Tribe, consult the agency responsible for pesticide regulation. . < . 11 i

STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage, disposal, or by cleaning of equipment. PESTICIDE STORAGE Keep out of reach of children and animals. Store in original containers only. Store in a cool, dry place and avoid excess heat. PESTICIDE DISPOSAL This pesticide's wastes are toxic. 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. 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 V4 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 Caaed IBC or Snvder 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. 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.- Snvder 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. To triple rinse the container 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. Refillable Containers Refillable container. Refill this container with pesticide only. Do not reuse this container for any other purpose. Do not remove tamper evident cables or one way valves or clean the container if the container is equipped witruone way valves and refilling or returning is planned. After emptying product from container, either return container to-E&yar CropScienca per instructions from Bayer CropScience Customer Service Center (1-800-527-4781) or rinse and either recycle o: dispose of th,3 container as follows: ' c < , < < i (. i. < ( c t i ( ( Bottom Discharge IBC (e.g. - Schuetz Caged IBC or Snyder Square Stackable) ' , t l t (11 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 toe IBC into application equipment or mix tank. Raise the bottom of the IBC by 1.5 inches on the side which is opposi'.e of-tlie bottom discharge valve to promote more complete product removal. Completely remove the top lid of the IBC. Use water pressurized to a*, .leas? 60 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. I <., L ^

Top Discharge IBC. Drums. Kegs (e.g. - Snvder 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. 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 agriculture 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: If the seed is treated with the product and the treated seed is soil-injected or soil-incorporated, the Worker Protection Standard, under certain circumstances, allows workers to enter the treated area if there will be no contact with anything that has been treated. 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. SEED LABELING To meet U.S. Federal Seed Act requirements, all seed treated with RAXIL ALLEGIANCE MD must be labeled: • TREATED SEED. • DO NOT USE FOR FOOD, FEED OR OIL PURPOSES. • Treated with Alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol (Tebuconazole) and Metalaxyl. • 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." RAXIL ALLEGIANCE MD Fungicide is a combination of the systemic fungicides, Tebuconazole and metalaxyl which aids in the control or suppression of the following seed, seedling and soilborne diseases of wheat, barley, oats and 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 and rust. In California - Registered only for use in commercial seed treating establishments. Not allowed for "on-farm" use. NOTE: If this product is undyed, the purchaser of this product is responsible for ensuring that all seed treated with this product are adequately dyed with a suitable color to prevent its accidental use as a food for man or feed for animals. Refer to 21 CFR, Part 2.25. Any dye added to treated seed must be cleared for use under 40CFR, parts 180.910,180.920, or 180.950. APPLICATION DIRECTIONS Use 5 - 6.5 fluid ounces of RAXIL ALLEGIANCE MD per 100 pounds of seed. Make applications using standard slurry or mist-type seed treatment equipment. In some instances, a water and chemical slurry dilution may enhance coverage. A 1 part RAXIL ALLEGIANCE MD with 1 part water dilution may be used. This product is for commercial or on-farm application. Do not use this product for direct application into a planter box. Uniform application to seed is necessary to ensure seed safety and best disease control. Seed should be sound and well cured prior to treatment. Consult your area agronomist regarding planting depth recommendations for the particular variety to be planted. Refillable Containers 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.

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, 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 OTHER 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. NET CONTENTS: RAXIL AND ALLEGIANCE are registered trademarks of Bayer Bayer CropScience 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 ALLEGIANCE MD Fungicide (MASTER) Approved 05/24/10, Notification 07/15/2011