U.S. EPA, Pesticides, Label, REGENT 80WG INSECTICIDE, 7/24/2009
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Dave G. Bolin, Ph.D. Product Registration JUL 2 4 2009 BASF Corporation, Agricultural Products PO Box 13528 Research Triangle Park, NC 27709-3528 SUBJECT: Application for Pesticide Notification (PRN 98-10) Request Directions for Use/General Label Change EPA Reg. No.7969-208 Application Dated June 4, 2009 Dear Registrant: The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10 dated 06/04/09 for the above product. 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 ofPRN 98-10. The label submitted with the application has been stamped "Notification" and will be placed in our records. If you have any questions, please call me directly at 703-305-6249 or Owen F. Beeder of my staff at 703-308-8899. Sincerely, ----y- Linda Arrington Notifications & Minor Formulations Team Leader Registration Division (7505P) Office of Pesticide Programs PI... e read iMtructiOM on l'fWene before comDleti"" fo"". Form ADDroved. OMB No. 2070-008(1 " emir.. 2-28-95 United States § 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 Manager 3. Proposed Classification 7969-208 Richard Gebken DNone [2] Restricted 4. Compeny/Product (Name) PM' REGENT 80 WG Insecticide 10 5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Reveiw. In accordance with FIFRA Section 3(cIl3) BASF Corp (b)(i), my product is similar or identical in composition and labeling PO Box 13528 I 26 Davis Drive to: EPA Reg. No. NOTIFICATION Research Triangle Park, NC 27709-3528 JUL 242009 o Check if this is a new address Product Name Section - II Amendment - Explain below. Final printed labels in repsonse to D U Agency letter dated D Resubmission in response to Agency letter dated 0 ·Me Too· Application. D Notification - Explain below. 0 Other - Explain below. Explanation: Use additional pagels) if necessary. (For section I and Section II.) Label notification in accordance with PR Notice 98-10. Attn: Label Notification Team No PRIA fee is associated with this action. Section - III 1. Material This Product Win Be Packaged In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container Yes ~yes ~yes gMO~,/ Plastic No No ~ No Glass If ·Yes· No. per If ·Yes· No. per Paper • Certification must Unit Packaging wgt. container Package wgt container Other (Specify) be submitted 10.44oz 6 I 3. location of Net Contents Information 4. Size(s) Retail Container 5. location of label Directions on label [{J label U Container 3.92 Ibs (6 X 4 X 2.61 oz) t==j 6. Manner in Which label is Affixed to Product t:j Uthograph Other .t Paper ~Iued 0 Stenci ad Section - IV ,. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.) Name Title Telephone No. (Include Area Code) Dave G. Bolin Product Registration Manager 919-547-2108 Certification 6. Date Application I certify that the statements I have mede on this form and all attachments thereto are true, accurate and complete. Received I acknowledge that any knowlinglly false or misleeding statement may be punishable by fine or imprisonment or (Stamped) both under applicable law. II It , 1 (t L 3. Title 2.S;gMMo N~f?J ~ l I~ <. I Product Registration Manager <. c , ' f j ;, , ... ~ 4. Typed Name 5. Date t.l. I ( , '. , Dave G. Bolin June 4,2009 I} 0 '} (. \1(<1\'''', '.' <- I. t. ( , , L ~ L . ~... "~'-- ~ EPA Form 8570-1 (Rev. 3-94) PreVIous editions are obsolete • White - EPA File Copy (onglnan'. ...•.. ~---~--~~---~------~ ~---------- -- ------------------------------------ a·BASF The Chemical Company Document Processing Desk (NOTIF) Office of Pesticide Programs (7504C) U.S. Environmental Protection Agency June 4, 2009 One Potomac Yard 2777 S. Crystal Drive Arlington, Virginia 22202 Re: Label Notification for REGENT® 80WG (EPA Reg. No. 7969-208) Dear Notification Team, BASF is hereby submitting an updated Label for Regent 80WG Insecticide. BASF believes that these changes are consistent with the Notification criteria as described under PR Notice 98-10. The label was changed as listed below. 1) "Regent 80WG Insectide cannot be used to formulate, reformulate or repackage into any other pesticide product without the written permission of BASF Corporation." (page 2) 2) Boxed Storage and Disposal text. 3) Updated Conditions of Sale and Warranty to current BASF standard. Attached to support this submission are two copies of the Label and completed EPA Form 8570-1. Please feel free to contact me (919-547-21081 [email protected]) if you have any questions This notification is consistent with the provisions ofPR 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 ofPR Notice 98-10 and 40 CFR 152.46, this product may be in violation ofFIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA. Respectfully Submitted, ~9/~ Dave G. Bolin, Ph.D. Product Registration Manager - U.S. Regulatory Affairs ® Registered Trademark ofBASF BASF Corporation Agricultural Products 26 Davis Drive ,,' '-~.:. c. Research Triangle Park, NC 27709 Tel: (800) 669-1770 l t .... ( www.agproducts.basf.com L l.. Y(1 NOTIFiCATiON ~BASF JUL 24 2009 The Chemical Company RESTRICTED USE PESTICIDE DUE TO TOXICITY TO AQUATIC INVERTEBRATES For retail sale to and use only by Certified Applicators or persons under their direct supervision, and only for those uses covered by the Certified Applicator's certification. REGENT® 80 WG Insecticide ACTIVE INGREDIENT: Fipronil: 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1 ,R,S)- (trifluoromethyl)sulfinyl) -1-H-pyrazole-3-carbonitrile ............................................................. 80% INERT INGREDIENTS: ......... ......... ... ...... .... ................... ...... ... ....... ....... .... ..... ... .... ..... ... .... 20% TOTAL ............................................................................................................................... 1000/0 Each pound of Regent® 80 WG insecticide contains 0.8 pound of the active ingredient Fipronil. EPA Reg. No. 7969-208 EPA Est. No. KEEP OUT OF REACH OF CHILDREN WARNING/AVISO Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If you do not understand the label, find someone to explain it to you in detail.) FOR MEDICAL AND TRANSPORTATION EMERGENCIES ONLY CALL 24 HOURS A DAY 1-800-832-HELP (4357) 24 HOURS A DAY See inside for First Aid, Precautionary Statements and Directions for Use. Net Contents: BASF Corporation 26 Davis Drive Research Triangle Park, NC 27709 FIRST AID -Immediately call a poison control center or doctor for treatment advice. -Do not induce vomiting unless told to do so by a poison control center or doctor. IF SWALLOWED -Have person sip a glass of water if able to swallow. -Do not give anything by mouth to an unconscious person. -Take off contaminated clothing. IF ON SKI NOR -Rinse skin immediately with plenty of water for 15-20 minutes. CLOTHIN G -Call a poison control center or doctor for treatment advice. -Move person to fresh air. -If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably IF INHALE D mouth-to mouth if possible. -Call a poison control center or doctor for further treatment advice. -Hold eye open and rinse slowly and gently with water for 15-20 minutes. IF IN EYE S -Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. -Call a poison control center or doctor for treatment advice. HOT LINE NUMBER For MEDICAL Emergencies: Call 24 Hours A Day 1-800-832-HELP (1-800-832-4357). Have the product container or label with you when calling a poison control center or doctor or going for treatment. SYMPTOMS OF POISONING In severe cases of overexposure by oral ingestion, lethargy, muscle tremors, and, in extreme cases, possibly convulsions, may occur. NOTE TO PHYSICIAN The re is no specific antidote. All treatment should be based on observed signs and symptoms of distress in the patient. Overexposure to materials other than this product may have occurred. GENERAL Contact a physician immediately in all cases of suspected poisoning. Transport patient to a physician or hospital immediately and S HOW A COPY OF THIS LABEL TO THE PHYSICIAN. If poisoning is suspected in animals, contact a veterinarian. p RECAUTIONARY STATEMENTS instructions, use detergent and hot water. Keep and wash PPE separately from other laundry. HAZARDS TO HUMANS When handlers use closed systems, enclosed cabs, or air AND DOMESTIC ANIMALS craft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides WARNING [40 CFR 170.240 (D) (4-6)], the handler PPE requirements MAY BE FATAL IF SWALLOWED, ABSORBED may be reduced or modified as specified in the WPS. THROUGH SKIN, OR INHALED. CAUSES MODERATE EYE IRRITATION. Do not get in eyes, on skin or on cloth USER SAFETY RECOMMENDATIONS ing. Do not breathe spray mist or vapor. Wash thoroughly Users Should: with soap a nd water after handling and before eating, -Wash hands before eating, drinking, chewing gum, drinking, ch ewing gum, or using tobacco. Remove con using tobacco or using the toilet. taminated cl othing and wash before reuse. -Remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. SYMPTOM S OF POISONING In severe cases of overexposure by oral ingestion, lethargy, ENVIRONMENTAL HAZARDS muscle trem ors, and, in extreme cases, possibly convul sions, may occur.