Document ID: EPA-HQ-OPP-2019-0265-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-03-23T04:00Z

Lepigen
             Biological insecticide for the integrated control of 
     Helicoverpa zea  (corn earworm, cotton bollworm, tomato fruitworm), 
Heliothis virescens (tobacco budworm), Chrysodeixis includens (soybean looper) and 
     Trichoplusia ni (cabbage looper) on specified food and non-food crops

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	Active Ingredient:
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	Autographa californica Multiple NPV Strain R3:	34.2%
Other ingredients:		65.8%	
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	Total:	100.0%
	Contains a minimum of 7.5 x10[9] occlusion bodies per milliliter of product

                         KEEP OUT OF REACH OF CHILDREN
                                    CAUTION
    See additional precautionary and first aid statements on the back panel

                                       
                    Net Contents: 0.25, 1, 2.5 or 5 gallons
                                       
EPA Registration Nº: 87978-T
EPA Est. Number: 

Manufactured for:
AgBiTech Pty Ltd
8 Rocla Court
Glenvale, Queensland 4350
Australia  

Product of USA

Batch code: ___________________

                                       

                                       
	
                                   FIRST AID
If on skin or clothing:
* Take off contaminated clothing.
* Rinse skin immediately with plenty of water for 15-20 minutes.
                                HOT LINE NUMBER
Have the product container or label with you when calling a poison control center or doctor, or going for treatment. 

For general information concerning this product, call the National Pesticide Information Center (NPIC) at 1-800-858-7378 seven days a week, 8 AM to 12 PM PST or at http://npic.orst.edu.  For medical emergencies, call the poison control center at 1-800-222-1222.
                                       
                                       
                                       
                                       
                           PRECAUTIONARY STATEMENTS
                                       
                    HAZARDS TO HUMANS AND DOMESTIC ANIMALS
                                    CAUTION
                                       

Harmful if absorbed through the skin. Avoid contact with skin 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)

Mixers, Loaders, Applicators and other handlers must wear:
   * Protective eyewear
   * Long-sleeved shirt and long pants
   * Waterproof gloves
   * Shoes plus socks

Mixers/loaders and applicators must wear a NIOSH-approved particulate respirator with any N, R or P filter with NIOSH approval number prefix TC-84A; or a NIOSH-approved powered air purifying respirator with an HE filter with NIOSH approval number prefix TC-21C. Repeated exposure to high concentrations of microbial proteins can cause allergic sensitization.

Follow the manufacturer's instructions for cleaning/maintaining PPE. If no such instructions are available, use detergent and hot water for washables. Keep and wash PPE separately from other laundry.

                           USER SAFETY RECOMMENDATIONS
                                       
Users should:
   * Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.
   * 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 product may be pathogenic to nontarget Lepidoptera exposed to direct treatment. Do not apply this product while nontarget Lepidoptera are actively visiting the treatment area. Minimize spray drift away from target area to reduce effects to nontarget Lepidoptera.

For terrestrial uses: 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 wash waters or rinsate.

                                       

                              DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling.
                                       
Do not use this product until you have read the entire label.  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 requirement specific to your State or Tribe, consult the State or Tribal agency responsible for pesticide regulation.

Do not apply by aerial application.

                                       
                                       
                         AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling and with Worker Protection Standard, 40 CFR Part 170.  This Standard contains requirements for the protection of agricultural workers on farm, 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 exemptions pertaining to the statements on this label about personal protective equipment (PPE) and restricted-entry interval. The requirements in this box apply only 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 4 hours.

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
   * Waterproof gloves
   * Shoes plus socks
   * Protective eyewear

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                       

                              PRODUCT INFORMATION
This product contains a biological insecticide for the control of the following moth larvae on labeled crops:
                Corn earworm, Cotton bollworm, Tomato fruitworm
           (Helicoverpa zea  + Tobacco bolworm (Heliothis virescens) 
                    Soybean looper (Chrysodeixis includes)
                       Cabbage looper (Trichoplusia ni)
                    Diamondback moth (Plutella xylostella)
                Velvetbean caterpillar (Anticarsia gemmatalis)
                     Fall Armyworm (Spodoptera frugiperda)
                           Beet Armyworn (S. exigua)
                        Southern Armyworm (S. eridania)
                                       
                                 INSTRUCTIONS 
                                       
Lepigen (Autographa californica Multiple NPV strain R3, AcMNPV) is a pathogen of Lepidopteran insects in the following species:  Helicoverpa zea , Heliothis virescens, Plutella xylostella,  Trichoplusia ni, Chrysodeixis includens, Spodoptera frugiperda, Spodoptera exigua, Spodoptera eridania, and Anticarsia gemmatalis. The effectiveness of Lepigen is dependent on a number of important factors; larval size, environmental conditions, application and the feeding behavior of the pest.  Because of the requirement for adequate timing of application, coverage, and weather conditions, the performance of Lepigen may be variable. Once infected, larvae can take up to 8 days to die, although feeding activity is greatly reduced within 1 to 3 days post infection, dependent on larvae size.  Daytime temperatures of 65°F to 95°F are ideal for the infectivity by Lepigen.  Infected larvae will amplify the virus, and following death will release large amounts of viral occlusion bodies that can result in ongoing control, particularly under environmental conditions suitable for the virus in Lepigen (warm and humid conditions).

Good coverage of the feeding sites of the larvae is essential, as the product needs to be ingested to be effective.  If larvae are feeding low down in a heavy crop canopy, and application of Lepigen does not reach these areas, initial control from the spray will be sub-optimal.  However, larvae that die from the Lepigen spray will release large amounts of AcMNPV, which will spread throughout the crop canopy.

                                     USES

Lepigen should only be used to target small larvae (1[st], 2[nd] and 3[rd] instars).  Larvae at the higher end of the recommended size spectrum will take longer to die and cause more significant damage prior to death. Under sub-optimal conditions where application cannot be delayed, increasing application volume and droplet size can improve coverage and performance.  
                                       
                                 RAIN FASTNESS

The majority of virus uptake occurs within one (1) hour post-application.  For this reason, it is best to avoid applying Lepigen if heavy rain is expected within one (1) hour following application.  However, do not delay application if only moderate rain is expected, or heavy rain (greater than 0.4 inches per hour) is not imminent.
            CROPS, APPLICATION RATES AND CROP SPECIFIC INFORMATION
Crops
Rate of Lepigen
per acre
Additional Information
Sorghum
0.7 to 1.4 fl. oz.
Use lower application rates when targeting larvae smaller than 0.3 inches in length (1st and 2nd instar) and in mixtures with sprays for midge control (not ULV).  Use higher application rates when targeting larvae larger than 0.3 inches in length (3rd instar) or under high pressure situations.  Applications that are targeted when 50% of heads have reached 100% flowering will provide good control.
Cereal Grains Group (Crop Group 15 excluding Sweet corn) including: Corn (maize), Popcorn, Rice
Alfalfa (hay and seed)
Oilseed Group (Crop Group 20) including: Flax seed, Canola, Safflower, Sunflower
Peanut
Legume Vegetables (Succulent or Dried) Group (Crop Group 6 excluding Peanut and Soybean) including: Adzuki bean, Broad bean, Chickpeas, Cowpea, Faba bean, Field pea, Kidney bean, Lablab bean, Lentil, Lima bean, Sweet lupin, White lupin, Mung bean, Navy bean, Pigeon pea 
Vetch
0.5 to 2.0 fl. oz.
Use lower application rates as a preventive measure in vegetative crop stages. Use the high application rate when the pest population has reached economic threshold.
Soybean (including Edamame)
0.5 to 2.0 fl. oz.
Use lower application rates as a preventive measure in vegetative crop stages. Use the high application rate when the pest population has reached economic threshold.
Sweetcorn
1.2 to 2.4 fl. oz.
Application should be made from the vegetative stages until silking. Applications during silking should employ a high application rate and be in conjunction with other control measures. Application of low rates at regular (3 to 5 day) intervals, particularly via overhead irrigation water, is an effective strategy from vegetative stages, through row tassel to silking.

Root and Tuber Vegetables Group (Crop Group 1) including: Carrot, Sweet potato, Sugar beet, Potato
Brassica (Cole) Leafy Vegetables Group (Crop Group 5) including: Broccoli, Brussels sprouts, Cabbages, Cauliflower, Chinese broccoli, Kale, Mustard greens, Mustard spinach, Rape greens
Leafy Vegetables (Except Brassica) Group (Crop Group 4) including: Celery, Endive, Lettuce, Roquette, Silver beet, Spinach
Fruiting Vegetables Group (crop Group 8  -  10) including: Chili, Eggplant, Okra, Peppers, Tomato
Cucurbit Vegetables Group (Crop Group 9) including: Cucumber, Melons Pumpkins Summer and winter Squash, Watermelon, Zucchini
Berries Group (Crop Group 13  -  07) including: Blackberry, Blueberry, Boysenberry, Cranberry, Currants, Gooseberry, Raspberry, Strawberry
Pome Fruit Group (Crop Group 11  -  10) including: Apple, Pear
Ornamental flowers and plants
Avocado
Asparagus
1.0 to 2.4 fl. oz.
Use a higher application rate when flowers, fruit or economic parts of the crop are present, under high pest pressure conditions or to control 3rd instar larvae. Use the lower application rate during vegetative stages of crop production. Application of low rates at regular (3 to 5 day) intervals, particularly via overhead irrigation water, is an effective strategy in horticultural crops.
Cotton
1.2 to 2.4 fl. oz.
High leaf pH in cotton causes rapid NPV deactivation, giving Lepigen very short residual activity and resulting in highly variable performance in this crop. Lepigen should not be solely relied upon when larvae numbers are above economic threshold in cotton.
Tobacco, Hemp
1.0 to 2.4 fl. oz.
Use a higher application rate under high pest pressure conditions or to control 3[rd] instar larvae. Using the lower application rate at regular intervals is an effective strategy in tobacco.
                                       
                                       
                               MIXING GUIDLINES
Shake the container well before use. Spray water pH should be neutral (pH 7.0)  -  spray water pH above 8 may damage the virus and performance will be reduced. If needed, use a suitable buffer or acidifier.  If mixing with other pesticides or foliar fertilizers in water, add Lepigen to the spray tank after the other products are thoroughly diluted. Apply Lepigen within 10 hours after mixing. 
Compatibility:
In water: Lepigen is highly compatible with the majority of herbicides, insecticides fungicides and foliar fertilizers when mixed in water.  Ensure that the mixture has a pH of 8 or less before adding Lepigen as higher pH levels will damage the virus.  

                           APPLICATION INSTRUCTIONS
Use application parameters (nozzles, swath width, pressure, boom height, speed, etc.) to ensure thorough coverage of the target area.

         I. Legume Vegetables (Succulent and Dried) Group (Crop Group 6 excluding Soybean), Root and Tuber Vegetables Group (Crop Group 1) including: Carrot, Sweet potato, Sugar beet, Potato; Brassica (Cole) Leafy Vegetables Group (Crop Group 5) including: Broccoli, Brussels sprouts, Cabbage, Cauliflower, Chinese broccoli, Kale, Mustard greens, Mustard spinach, Rape greens); Leafy Vegetables (except Brassica Vegetables) Group (Crop Group 4) including: Celery, Endive, Lettuce, Roquette, Spinach; Fruiting Vegetable Group (Crop Group 8 - 10) including: Chili, Eggplant, Okra, Pepper, Tomato; Cucurbit Vegetables Group (Crop Group 9) including: Cucumber, Melon, Pumpkin, Summer and winter squash, Watermelon, Zucchini; Berries Group (Crop Group 13 - 07) including: Blackberry, Blueberry, Boysenberry, Cranberry, Currant, Gooseberry, Raspberry, Strawberry; Pome Fruit Group (Crop Group 11 - 10) including: Apple, Pear; Ornamental Flowers and Plants; Avocado; Asparagus; Tobacco; Hemp.

    Ground Rig
    Apply Lepigen by ground rig or hand-held equipment in a minimum of 40 gallons of water per acre.

         II. Sorghum, Cereal Grains Group, Alfalfa, Oilseed Group, Peanut, Soybean, Sweet Corn, Cotton

    Ground Rig
    Apply Lepigen in a minimum of 10 gallons of water per acre.

Chemigation (via overhead irrigation water):
Lepigen can be effectively applied to crops in overhead irrigation water. The product should be introduced to the irrigation water at the appropriate rate using irrigation equipment. If the product is diluted in water prior to injection into the irrigation water, ensure that the dilution water is clean and not silty with a pH of 7 or less and ensure there is constant agitation. Preferably, rainwater should be used for dilution. Apply Lepigen within 10 hours of mixing.
For one-pass mobile irrigators (such as: center-pivot; lateral-move; end-tow; side-roll; traveler; big-gun), continuously and evenly introduce the required quantity of Lepigen into the irrigation water over the course of irrigation. It is recommended to apply Lepigen in no more than 0.5 inches of irrigation water. For static irrigators (such as: solid-set or hand-move), introduce the required amount of Lepigen into the irrigation water just prior to completion of the irrigation period, to maximize the concentration of Lepigen applied and the amount that remains on the crop. See the CHEMIGATION section (following) for additional information.

CHEMIGATION
General Requirements:
   1) Apply this product only through overhead sprinkler (including center pivot, lateral move, end tow, side (wheel) roll, traveler, big gun, solid set, or hand move) irrigation systems.  Do not apply this product through soil irrigation systems including drip (trickle).
   2) Crop injury, lack of effectiveness, or illegal pesticide residues in the crop can result from non-uniform distribution of treated water.
   3) If you have questions about calibration, you should contact State Extension Service specialists, equipment manufacturers, or other experts.
   4) Do not connect an irrigation system (including greenhouse systems) used for pesticide application to a public water system unless the pesticide label-prescribed safety devices for public water systems are in place.
   5) A person knowledgeable of the chemigation system and responsible for its operation, or under the supervision of the responsible person, shall shut the system down and make any necessary adjustments should the need arise.

Requirements for Chemigation Systems Connected to Public Water Systems:
   1) Public water supply means a system for the provision to the public of piped water for human consumption if such system has at least 15 service connections or regularly serves an average of 25 individuals daily at least 60 days throughout the year.
   2) Chemigation systems connected to the public water systems must contain a functional, reduced-pressure zone (RPZ), backflow preventer or the functional equivalent in the water supply upstream from the point of pesticide introduction. As an option to the RPZ, the water from the public water system should be discharged into a reservoir tank prior to pesticide introduction. There shall be a complete physical break (air gap) between the flow outlet end of the fill pipe and the top or the overflow rim of the reservoir tank of at least twice the inside diameter of the fill pipe.
   3) The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump.
   4) The pesticide injection pipeline must contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down.
   5) The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops, or in cases where there is no water pump, when the water pressure decreases to the point where pesticide distribution is adversely affected.
   6) Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump), effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock.
   7) Do not apply when wind speed favors drift beyond the area intended for treatment.

Requirements for Sprinkler Chemigation:
   1) The system must contain a functional check valve, vacuum relief valve, and low pressure drain appropriately located on the irrigation pipeline to prevent water source contamination from back flow.
   2) The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump.
   3) The pesticide injection pipeline must also contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down.
   4) The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops.
   5) The irrigation line or water pump must include a functional pressure switch, which will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected.
   6) Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump), effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock.
   7) Do not apply when wind speed favors drift beyond the area intended for treatment.

                                DAYS TO HARVEST
There are no restrictions on applying Lepigen up to the time of harvest.

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STORAGE or DISPOSAL
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Do not contaminate water, food, or feed by storage and disposal.
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PESTICIDE STORAGE
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Care must be taken to avoid exposure of Lepigen to high temperatures (above 104ºF). Packaged sealed product can be exposed to direct sunlight for brief periods of time (<2 hours), but should be kept out of direct sunlight.
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   # --------------------------------------------------------------------------------
   Lepigen stored in air-conditioned rooms (< 77°F ) will be viable for at least 6 months
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   Lepigen stored in cool rooms and refrigerators (0°F to 59°F) will be viable for at least 12 months*
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*Lepigen stored in a freezer (0°F) will remain liquid. 
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Note.  Exposure of Lepigen to temperature from 77°F to 104°F for short periods (<36 hours) will not affect efficacy.  Transport time of 36 hours or less in non-refrigerated, covered trucks is acceptable as long as the product does not exceed 104°F.
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PESTICIDE DISPOSAL
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To avoid waste, apply product in this container by application according to label directions.  If waste cannot be avoided, offer remaining product to a waste disposal facility or pesticide disposal program (often such programs are run by state or local governments or by industry).
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CONTAINER HANDLING
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[Plastic containers with capacities equal to or less than 5 gallons:] Nonrefillable container. Do not reuse or refill this container. Triple 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. Then offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration. Do not burn, unless allowed by state and local ordinance. If burned, stay out of smoke. 
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                                   WARRANTY
This product is warranted to contain the amount of active ingredients as described in this label and that the product will be as effective as intended if properly transported, used, and applied per the label instructions. The effectiveness of this product may be degraded by improper storage, transportation or handling and may be subject to environmental factors out of AgBiTech Pty Ltd's control.  The user must monitor the performance of the product as climatic, geographical or biological variables and/or developed resistance may affect the results obtained. To the extent allowed under the applicable law, AgBiTech Pty Ltd and its subsidiaries 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 or accepts no responsibility in respect of this product. To the extent consistent with applicable law, AgBiTech Pty Ltd and its subsidiaries disclaim any liability whatsoever for special, incidental or consequential damages resulting from the use or handling of this product.