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:

71512-22 

Date of Issuance: 

7/21/15 

NOTICE OF PESTICIDE: 

 X Registration 

 Reregistration

Term of Issuance: 

Conditional 

 (under FIFRA, as amended)

Name of Pesticide Product:

Isofetamid 400SC 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 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 registered 

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. 

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 required for registration/reregistration/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. 71512-22 

Decision No. 474286 

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

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

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

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

months from the date of this Registration Notice. 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 cancellation 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. 71512-22.” 

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 company’s website on your label, then please be aware 

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

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

and unlawful to sell or distribute 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, regardless 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. Therefore, should the Agency find or if it is brought to 

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

the EPA approved registration, the website will be referred 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 conditions. A stamped copy of the label is enclosed for your records. 

Please also note that the record for this product currently contains the following CSF: 

 Basic CSF dated 12/14/2012 

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

garvie.heather@epa.gov. 

Enclosure 
Page 1

FIRST AID

If swallowed x Call a poison control center or doctor immediately 

for treatment advice.

x Have person sip a glass of water if able to swallow.

x Do not induce vomiting unless told to do so by a

poison control center or doctor.

x Do not give anything to an unconscious person.

If on skin x Take off contaminated clothing.

x Rinse skin immediately with plenty of soap and 

water for 15-20 minutes.

x Call a poison control center or doctor for treatment 

advice.

Have the product container or label with you when calling a poison control 

center or doctor, or going for treatment.

HOT LINE NUMBER

For 24-Hour Medical Emergency Assistance (Human or Animal) 

Call 1-888-484-7546.

For Chemical Emergency, Spill, Leak, Fire or Accident, Call 

CHEMTREC 1-800-424-9300.

ISOFETAMID 

FUNGICID

ACTIVE INGREDIENT: Isofetamid* ..OTHER INGREDIENTS: .....................Total.......................................................*N-[1,1-dimethyl-2-[2-methyl-4-(1-meth2-oxoethyl]-3-methyl-2-thiophenecarboContains 3.33 pounds Isofetamid Per GaKEEP OUT OF REACH OF CHILDRCAUTIONSee side panel for additional precautioRead entire label carefully and use onISK Biosciences Corporation7470 Auburn Road, Suite AConcord, Ohio 44077 U.S.A.EPA Reg. No. 71512-EE EPActive Ingredient Made in JapanFormulated in Net Contents: 

GRO

07/21/2015

71512-22
Page 2

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION

Harmful if swallowed or absorbed through skin. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Personal Protective Equipment (PPE)Applicators and other handlers must wear long-sleeved shirt and long pants, socks, shoes, and chemical resistant gloves made of any waterproof material.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.Engineering Control StatementsWhen handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS.

User Safety RecommendationsUsers should:x Wash hands before eating, drinking, chewing gum, using tobacco or

using the toilet.

x Remove clothing/PPE immediately if pesticide gets inside. Then wash 

thoroughly and put on clean clothing.

x 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 toxic to oysters. 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 waters when disposing of equipment washwaters or rinsate. Do not apply when weather conditions 

favor drift from the treated areas. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS THE RESPONSIBILITY OF THE APPLICATOR. The interaction of many 

equipment-and-weather-related factors dete

drift. The applicator is responsible for conmaking decisions. Where states have momust be observed.

STORAGE AND DISPOSAL

DO NOT contaminate water, food or feed bPESTICIDE STORAGE: Store in origincool place separate from fertilizer, foo

contamination with other pesticides.PESTICIDE DISPOSAL: Pesticide Improper disposal of excess pesticide, sviolation of Federal law. If these wastes according to label instructions, contacEnvironmental Control Agency or the Hazthe nearest EPA Regional Office for guidanCONTAINER HANDLING: Nonrefillab

than 5 gallons). DO NOT reuse or refill container (or equivalent) promptly after follows: Empty the remaining contents inmix tank and drain for 10 seconds after thcontainer 1⁄4 full with water and recap. Shakinto application equipment or a mix tank odisposal. Drain for 10 seconds after the floprocedure two more times. Then offer puncture and dispose of in a sanitary lanallowed by state and local authorities, by bsmoke.Nonrefillable container (greater than 5 galthis container. Triple rinse container (oemptying. Triple rinse as follows: Empty application equipment or a mix tank. Fill tRecap and tighten closures. Tip container forth, ensuring at least one complete revolucontainer on its end and tip it back and fcontainer over onto its other end and tip it Empty rinsate into application equipment or later use or disposal. Repeat this procedurfor recycling if available, or puncture and d
Page 3

or by incineration or, if allowed by state and local authorities, by burning. If burned, stay out of smoke.

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 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.AGRICULTURAL USE REQUIREMENTSUse 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 twelve (12) hours. PPE required for early entry into 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.FAILURE TO FOLLOW THE USE DIRECTIONS AND PRECAUTIONS ON THIS LABEL MAY RESULT IN PLANT INJURY OR POOR DISEASE CONTROL.PRODUCT INFORMATIONISOFETAMID is a broad-spectrum fungicide with preventative, systemic and curative properties for foliar and soil-borne diseases. ISOFETAMID must be applied in scheduled protective programs and used in rotation with 

products with a different mode of action. 

MIXING AND SPRAYINGISOFETAMID 400SC can be used effectsprays. Thorough, uniform coverage is esseNOTE: Slowly invert container several timformulation before adding this product to th

Dosage rates on this label indicate fluid ou

per acre, unless otherwise stated. Under cdisease development, the highest rate speinterval should be used. ISOFETAMID 400SC may be applied witnormally used for ground, chemigation th

aerial applications.The required amount of ISOFETAMID 40into the spray tank during filling. With c

required amount of ISOFETAMID 400SC the spray tank as it is being filled. Keep spray tank and during spray operations. DO stand overnight or for prolonged periods. spray required for immediate use. Spthoroughly cleaned immediately after the apApply ISOFETAMID 400SC in sufficie

coverage of the foliage. Gallonage to be amount of plant growth. Spray volume wilgallons per acre (200 to 1000 liters per hect10 gallons per acre (50 to 100 liters per hand aerial sprays. For aerial applications, aa minimum of 5 gallons of water per asprinkler irrigation systems see applicatiobelow.

TANK MIX COMPATIBILITYISOFETAMID 400SC is physically comblockage) with many products labeled for on crops and other additives. Read and f

precautions and restrictions for the tank miapplicator’s responsibility to ensure that thapproved for use on the intended crop. ISO
Page 4

compatible with other insecticides, fungicides, adjuvants, fertilizers andmicronutrient products provided sufficient free water is available for dispersion of all the tank mix products. Under some conditions, the use of adjuvants and surfactants at the rate of 0.025% to 0.1% of the spray tank volume may improve the performance of ISOFETAMID 400SC. 

However, not all crop varieties have been tested with all possible tank mix combinations. Thus the combination should be tested for crop safety on a small portion of the crop to ensure that a phytotoxic response will not occur. In addition, the physical compatibility of ISOFETMAID 400SC with tank mix partners must be evaluated before use. Conduct a jar test with intended tank-mix pesticides prior to preparation of large volumes. Use the following procedure: 1) Pour the recommended proportions of the products into a suitable container of water, 2) Mix thoroughly and 3) Allow to stand for 5 minutes. If the combination remains mixed or can be re-mixed readily, it is considered physically compatible. Any physical incompatibility in the jar test indicates that ISOFETAMID 400SC should not be used in the tank-mix.

ROTATIONAL CROP RESTRICTIONSCrops on this label may be planted immediately after the last treatment. Do not plant other crops not registered for this product within 30 days after the last application. INTEGRATED PEST MANAGEMENTISOFETAMID 400SC is an excellent disease control agent when used according to label directions for control of labeled fungi. ISOFETAMID

400SC is recommended for use as part of an Integrated Pest Management(IPM) program, which may include the use of disease-resistant crop varieties, cultural practices, crop rotation, biological disease control agents, pest scouting and disease forecasting systems aimed at preventing economic pest damage. Practices known to reduce disease development should be followed. Consult your state cooperative extension service or local agricultural authorities for additional IPM strategies established in your area. ISOFETAMID 400SC may be used in State Agricultural 

Extension advisory (disease forecasting) programs that recommend application timing based upon environmental factors that favor disease development.

RESISTANCE MANAGEMENTSome plant pathogens are known to develop resistance to products used repeatedly for disease control. ISOFETAMID 400SC’s mode/target site of action is complex II; succinate-dehydrogenase, FRAC Group 7. A disease management program that includes alternation or tank mixes 

between ISOFETAMID 400SC and other different mode of action and/or control pISOFETAMID 400SC is essential to prevepopulations from developing. ISOFETA

utilized continuously nor tank mixed with have developed fungal resistance to the targSince pathogens differ in their potentiafungicides, follow the directions outlined section of this label for specific resistanceach crop. Consult with your Federal or Service representatives for guidance on the 400SC in programs that seek to minimizresistance. ISOFETAMID 400SC is no

classes of fungicides that have different moAPPLICATION AND CALIBRATION TSPRINKLER IRRIGATIONApply this product only through center ptraveling gun, solid set or portable (wheehand move) irrigation system(s). DO NOT other type of irrigation system.Crop injury, lack of effectiveness, or illegacan result from non-uniform distribution of If you have questions about calibratioExtension Service specialists, equipment mDO NOT apply ISOFETAMID 400SC connected to a public water system. “Psystem for the provision to the public consumption if such system has at learegularly serves an average of at least 25 inper year.Controls for both irrigation water and pestifunctionally interlocked, so as to autoinjection when the irrigation water pumknowledgeable of the irrigation system anshall be present so as to discontinue necessary adjustments, should the need aris
Page 5

The irrigation water pipeline must be fitted with a functional, automatic, quick-closing check valve to prevent the flow of treated irrigation water back toward the water source. The pipeline must also be fitted with a vacuum relief valve and low-pressure drain, located between the irrigation water pump and the check valve, to prevent back-siphoning of treated irrigation water into the water source.Always inject ISOFETAMID 400SC into irrigation water after it discharges from the irrigation pump and after it passes through thecheck valve. Never inject pesticides into the intake line on the suction side of the pump.Pesticide injection equipment must be fitted with a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump. Interlock this valve to the power system, so as to prevent fluid from being withdrawn from the chemical supply tank when the irrigation system is either automatically or manually turned off.The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the 

injection pump. The irrigation line or water pump must include a functional pressure switch that will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected.Spray mixture in the chemical supply tank must be agitated at all times, otherwise settling and uneven application may occur. DO NOT apply when wind speed favors drift beyond the area intended for treatment.ISOFETAMID 400SC may be used through two basic types of sprinkler irrigation systems as outlined in Sections A and B below. Determine which type of system is in place, then refer to the appropriate directions provided for each type.

A. Center Pivot, Motorized Lateral MIrrigation EquipmentFor injection of pesticides, these continuouspositive displacement injection pump of eitconstructed of materials that are compatiblof being fitted with a system interlock pressures approximately 2-3 times those enwater line. Venturi applicator units cannot Thoroughly mix labeled amount of this prointo the same amount of water used durisystem continuously for one revolution or supply tank must be continuously agitated off injection equipment after one revoluoperate irrigation system until this product sprinkler head.B. Solid Set and Portable (Wheel Mo

Hand Move) Irrigation Equipmen

With stationary systems, an effectively desunit is preferred which is constructed of mapesticides; however, a positive-displacemenDetermine acreage covered by sprinkler. Fwith water and adjust flow to use contents Mix desired amount of ISOFETAMID 400with water so that the total mixture of tinjection tank is equal to the quantity of watAgitation is recommended. ISOFETAMID beginning or end of the irrigation cycle or injection equipment after treatment is comirrigation system until this product has behead.
Page 6

DIRECTIONS FOR USE

Crop Diseases

Use Rate

Fl. Oz. Product

Per Acre

Instructions

Almond Brown rot blossom 

blight (Monilinia spp.)

Anthracnose (Colletotrichum sp.)

Gray mold (Botrytis cinerea)Shot hole (Wilsonomyces carpophilus)

13.5 to17 fl oz

(0.351 to 0.442 

lb. a.i. /A)

Application Instructions:Initiate applications for brown rot blossom blight when conditions are favand continue on a 7-14 day interval. Typically applications are started continued through petal fall. Initiate application for control of anthracnose, gray mold, and shot hole needed on a 7-14 day interval. If disease pressure is severe use the higher Apply ISOFETAMID 400SC in sufficient water to obtain adequate cvolume will usually be 50 to 100 gallons per acre for dilute sprays and 5 sprays. For aerial applications, apply ISOFETAMID 400SC in a minim

acre. For dilute sprays, if higher spray volumes are desired for improvmaximum rate of 17 fl oz of product per acre.Resistance Management:Do not make more than 2 sequential applications of ISOFETAMID 400S

fungicide before rotating to a fungicide with a different mode of action. D

of ISOFETAMID 400SC within 14 days of the second application.

Restrictions:Do Not apply more than 68 fl oz/A/year (1.77 lb. a.i./A/year)Do Not apply after first cover.

Lettuce

Head and Leaf

Sclerotinia drop (Sclerotinia minor, Sclerotiniasclerotiorum)

12.3 fl oz

(0.320 lb a.i. /A)

Application Instructions:On direct seeded lettuce make the first application after emergence, thinni

developmentOn transplanted lettuce make the first application immediately after transpdisease development.Make a second application if conditions continue to favor disease developApply ISOFETAMID 400SC in sufficient water to obtain adequate cvolume will usually be 50 gallons per acre for dilute sprays and 5 to 10 gFor aerial applications, apply ISOFETAMID 400SC in a minimum of 5 gResistance Management:Do not make more than 2 sequential applications of ISOFETAMID 400SC 

fungicides before rotating to a fungicide with a different mode of action. 

Restrictions:Do Not apply more than 24.6fl oz/A/year (0.64 lb. a.i./A/year)The Pre-Harvest Interval (PHI) for this crop is 14 days.
Page 7

Crop Diseases

Use Rate

Fl. Oz. Product

Per Acre

Instructions

Grapes,Crop Subgroup 13-07F

Botrytis bunch rot (Botrytis cinerea)

Powdery mildew (Erysiphe necator)Anthracnose (Colletotrichum sp.)

20 to 22 fl oz

(0.520 to 0.572

lb. a.i. /A)

Application Instructions:

For use on all types of grapes (wine, table, raisin, and juice).

For bunch rot make applications at critical timings for Botrytis control. at early bloom, bunch closure, veraison and pre-harvest (at least 14 daywater to allow for penetration into the foliage to obtain complete cover

spray volume per acre.

For powdery mildew and anthracnose begin fungicide applications prevenon a 7 to 14-day interval. When disease pressure is severe use the higher Resistance Management:Do not make more than 2 sequential applications of ISOFETAMID 400S

fungicides before rotating to a fungicide with a different mode of action. 

of ISOFETAMID 400SC within 28 days of the second application.

Restrictions:Do Not apply more than 66 fl oz/A/year (1.72 lb. a.i./A/year)The Pre-Harvest Interval (PHI) for this crop is 14 days.

Includes all members of the Fruit, Small Vine Climbing Crop Subgroup 13-07F, except fuzzy kiwifruit: Amur river grape; gooshardy; maypop; schisandra berry; and cultivars, varieties, and/or hybrids of these.Low Growing Berry, Crop Subgroup 13-07G

Gray mold (Botrytis cinerea)Powdery mildew (Podosphaera aphanis)

Anthracnose (Colletotrichum fragariae)

13.5 to 15.5 fl 

oz

(0.351 to 0.40

lb. a.i. /A)

Application Instructions:Initiate applications prior to disease development and continue on a 14-dapressure is high use the high rate.Apply ISOFETAMID 400SC in sufficient water to obtain adequate cvolume will usually be 50 to 100 gallons per acre for dilute sprays and 5 sprays. For aerial applications, apply ISOFETAMID 400SC in a miniacre. Resistance Management:Do not make more than 2 sequential applications of ISOFETAMID 400S

fungicides before rotating to a fungicide with a different mode of action. of ISOFETAMID 400SC within 28 days of the second application.

Restrictions:Do Not apply more than 54 fl oz/A/year (1.40 lb. a.i./A/year)The Pre-Harvest Interval (PHI) for this crop is 0 days.

Includes all members of the Low Growing Berry Crop Subgroup 13-07G: Bearberry; bilberry; blueberry, lowbush; cloudberry; c

muntries; partridgeberry; strawberry; and cultivars, varieties, and/or hybrids of these.
Page 8

Crop Diseases

Use Rate

Fl. Oz. Product

Per Acre

Instructions

Rapeseed, (Canola) Crop Subgroup 20A

Sclerotinia stem rot (Sclerotinia sclerotiorum)

10.25 to 12 fl oz

(0.267 to 0.312

lb. a.i. /A)

Application Instructions:

Initiate applications at 20 to 40% flowering (BBCH 62-64) or prior to dishigher rates for extended disease control. A second application may be mfavorable for disease development near the end of flowering (BBCH 67-6

Apply ISOFETAMID 400SC in sufficient water to obtain adequate coverwill usually be 50 to 100 gallons per acre for dilute sprays and 5 to 10 gFor aerial applications, apply ISOFETAMID 400SC in a minimum of 5 gResistance Management:Do not make more than 2 sequential applications of ISOFETAMID 400SC 

fungicides before rotating to a fungicide with a different mode of action. Restrictions:Do Not apply more than 24 fl oz/A/year (0.63 lb. a.i./A/year)

Includes all members of the Oilseed Crop Subgroup 20A: Borage; crambe; cuphea; echium; flax seed; gold of pleasure; hare’s elunaria; meadowfoam; milkweed; mustard seed; oil radish; poppy seed; rapeseed (Brassica napus, B. campestris, and Crambe a

varieties only which include canola and crambe)); sesame; sweet rocket; and cultivars, varieties, and/or hybrids of these.

WARRANTY AND LIMITATION OF DAMAGES

Seller warrants to those persons lawfully acquiring title to this product that at the time of first sale of this product by Seller that this product conformed to its chemical description and was reasonably fit for the purposes stated on the label when used in accordance with Seller’s directions under normal conditions of use. To the extent consistent with applicable law, Buyers and users of this product assume the risk of any use contrary to such directions. EXCEPT AS PROVIDED 

ELSEWHERE IN WRITING CONTAINING AN EXPRESS REFERENCE TO THIS WARRANTY AND LIMITATION OF DAMAGES, SELLER MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY OR GUARANTY, INCLUDING ANY 

ISK Biosciences Corporation7470 Auburn Road, Suite AConcord, Ohio 44077 U.S.A.

OTHER EXPRESS OR IMPLIED WAROF MERCHANTABILITY, AND NO AUTHORIZED TO DO SO. In no event breach of warranty or guaranty exceed the as to which a claim is made. To the extent Buyers and users of this product are respofrom use or handling of this product which the control of Seller, including, but not liother products unless otherwise expressly pof this product, weather conditions, cultural or other environmental conditions outside orecognized as being conducive to good agpractices.