Registration Notice Conditional v.20150320 U.S. ENVIRONMENTAL PROTECTION AGENCY

Office of Pesticide Programs

Registration Division (7505P)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460 EPA Reg. Number:



# 71512-21 Date of Issuance:



# 7/21/15

NOTICE OF PESTICIDE:

X Registration

Reregistration Term of Issuance:



# Conditional

(under FIFRA, as amended)

Name of Pesticide Product:



# Technical Isofetamid Fungicide

Name and Address of Registrant (include ZIP Code):



# Michael Peplowski

ISK Biosciences Corporation

7470 Auburn Road, Suite A

Concord, OH 44077

Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and ac cepted by the

Registration Division prior to use of the label in commerce. In any correspondence on this product always refer to the above E PA registration number.



# On the basis of information furnished by the registra nt, the above named pesticide is hereby registered

under the Federal Insecticide, Fungicide and Rodenticide Act.

Registration is in no way to be construed as an en dorsement or recommendation of this product by the

Agency. In order to protect health and the enviro nment, the Administrator, on his motion, may at any

time suspend or cancel the registration of a pesticid e 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.

This product is conditionally registered in accordance with FIFRA section 3(c)(7)(C). You must comply

with the following conditions:

1. Submit and/or cite all data requ ired for registration/reregistra tion/registration review of your

product under FIFRA when the Agency requires all registrants of similar products to submit such

data.

Signature of Approving Official:



# Tony Kish, Product Manager 22

Fungicide Branch, Registration Division (7505P) Date:



# 7/21/15

EPA Form 8570-6

# Page 2 of 2

EPA Reg. No. 71512-21

Decision No. 492105 and 474283

2. You are required to submit to the Agency the follo wing three studies: acute oral toxicity to larval

honey bees; chronic oral toxicity to larval honey bees; and chroni c oral toxicity to adult honey

bees. Protocols for each of the chronic studies are required prior to ini tiating the studies. The

protocols are due 3 months from the date of th is Registration Notice. The studies are due 12

months from the date of this Registration No tice. Thus, the 12 months includes submission and

review of both the protocols and data. Your failure to provide these data in a timely or adequate

manner may result in initiation of a cancel lation action against your registration.

3. Make the following label change before you release the product for shipment:

 Revise the EPA Registration Number to read, “EPA Reg. No. 71512-21.”

4. Submit one copy of the final printed label for the record before you release the product for

shipment.

Should you wish to add/retain a reference to the comp any’s website on your label, then please be aware

that the website becomes labeling under the Federal Insec ticide Fungicide and Rodenticide Act and is

subject to review by the Agency. If the website is false or mislead ing, the product would be misbranded

and unlawful to sell or distribu te 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, re gardless 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. Ther efore, should the Agency fi nd or if it is brought to

our attention that a website contains false or mislea ding statements or claims substantially differing from

the EPA approved registration, the website will be re ferred to the EPA’s Office of Enforcement and

Compliance.

If you fail to satisfy these data requirements, EPA will consider appropriate regulatory action including,

among other things, cancellation under FIFRA section 6(e). Your release for shipment of the product

constitutes acceptance of these cond itions. A stamped copy of the label is enclosed for your records.

Please also note that the record for this product currently contai ns the following CSFs:

 Basic CSF dated 06/18/2014

 Alternate CSF 1 dated 06/18/2014

If you have any questions, please contact Heathe r Garvie by phone at 703-308-0034, or via email at

garvie.heather@epa.gov.

EnclosureFIRST AIDIf swallowedxCall a poison control center or doctor immediatelyfor treatment advice.xHave person sip a glass of water if able to swallow.xDo not induce vomiting unless told to do so by apoison control center or doctor.xDo not give anything to an unconscious person.If on skin orclothingxTake off contaminated clothing.xRinse skin immediately with plenty of water for15-20 minutes.xCall a poison control center or doctor for treatmentadvice.Have the product container or label with you when calling a poison controlcenter or doctor, or going for treatment.HOT LINE NUMBERFor24-Hour Medical Emergency Assistance(Human or Animal)Call1-888-484-7546.ForChemical Emergency, Spill, Leak, Fire or Accident, CallCHEMTREC 1-800-424-9300.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS AND DOMESTIC ANIMALSCAUTIONHarmful if swallowed or absorbed through skin. Avoid contact with skin,eyes or clothing. Wash thoroughly with soap and water after handling andbefore eating, drinking, chewing gum, using tobacco, or using the toilet.Remove and wash contaminated clothing before reuse. Wear long-sleevedshirt and long pants, socks, shoes and gloves.TECHNICAL ISOFETAMIDFUNGICIDEACTIVE INGREDIENT: Isofetamid * .................................. 96.3%OTHER INGREDIENTS: ........................................................ 3.7%Total ...................................................................................... 100.0%*N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2-thiophenecarboxamideKEEP OUT OF REACH OF CHILDRENCAUTIONRead entire label carefully and use only as directed.ISK Biosciences Corporation7470 Auburn Road, Suite AConcord, Ohio 44077 U.S.A.EPA Reg. No. 71512-EREPA Est. No. 049036-JPN-001Manufactured in JapanNet Contents: 220 Pounds (100 kilograms)07/21/201571512-21ENVIRONMENTAL HAZARDSDO NOT discharge effluent containing this product into lakes, streams,ponds, estuaries, oceans, or other waters unless in accordance with therequirements of a National Pollutant Discharge Elimination System(NPDES) permit and the permitting authority has been notified in writingprior to discharge. Do not discharge effluent containing this product tosewer systems without previously notifying the local sewage treatment plantauthority. For guidance contact your State Water Board or Regional Officeof the EPA.DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistentwith its labeling.THIS PRODUCT IS FOR MANUFACTURING USE ONLY. It is only tobe used for formulation into end-use products registered for use onalmonds, lettuce, grapes (Crop subgroup 13-07F), low growing berries(Crop subgroup 13-07G), rapeseed (Crop subgroup 20A), and turf areasassociated with golf courses (greens, tees and fairways), sod farms, seedfarms, college and professional sports fields, residential and commerciallawns, or other uses approved by the US Environmental Protection Agency.STORAGE AND DISPOSALDO NOT contaminate water, food or feed by storage or disposal. Opendumping is prohibited.PESTICIDE STORAGE: Store in original container, in a secured, dryand cool place separate from other pesticides, fertilizer, food, and feed.PESTICIDE DISPOSAL: Pesticide wastes are toxic. Improper disposalof excess pesticide, pesticide spray or rinsate is a violation of Federal law.If these wastes cannot be disposed of by use according to labelinstructions, contact your State Pesticide or Environmental ControlAgency or the Hazardous Waste representative at the nearest EPARegional Office for guidance.ISK Biosciences Corporation7470 Auburn Road, Suite AConcord, Ohio 44077 U.S.A.CONTAINER HANDLING: Nonrefillable container. DO NOT reuseor refill this liner. Completely empty liner by shaking and tapping sidesand bottom to loosen clinging particles. Empty residue into formulationequipment. Then offer for recycling if available or dispose of liner in asanitary landfill or by incineration or, if allowed by state and localauthorities, by burning. If burned, stay out of smoke. If drum iscontaminated and cannot be reused, dispose of it in the manner requiredfor its liner.WARRANTY AND LIMITATION OF DAMAGESSeller warrants to those persons lawfully acquiring title to this productthat at the time of first sale of this product by Seller that this productconformed to its chemical description and was reasonably fit for thepurposes stated on the label when used in accordance with Seller’sdirections under normal conditions of use. To the extent consistent withapplicable law, Buyers and users of this product assume the risk of anyuse contrary to such directions.EXCEPT AS PROVIDEDELSEWHERE IN WRITING CONTAINING AN EXPRESSREFERENCE TO THIS WARRANTY AND LIMITATION OFDAMAGES, SELLER MAKES NO OTHER EXPRESS ORIMPLIED WARRANTY OR GUARANTY, INCLUDING ANYOTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS OROF MERCHANTABILITY, AND NO AGENT OF SELLER ISAUTHORIZED TO DO SO.In no event shall Seller’s liability for anybreach of warranty or guaranty exceed the purchase price of the productas to which a claim is made. To the extent consistent with applicable law,Buyers and users of this product are responsible for all loss or damagefrom use or handling of this product which results from conditions beyondthe control of Seller, including, but not limited to, incompatibility withother products unless otherwise expressly provided in Directions for Useof this product, weather conditions, cultural practices, moisture conditionsor other environmental conditions outside of the ranges that are generallyrecognized as being conducive to good agricultural and/or horticulturalpractices.ISOFETAMID TECH - 03202015