. '. .3 - d-S-J-oog- . UNITED S(=~ES ENVIRONMENTAL PROTECTION AG('~CY

Christine A. Dively MAR 25 2008 Director of Regulatory Affairs Certis USA 9145 Guilford Road, Suite 175 Columbia, MD 21046

Dear Ms. Dively:

Subject: Javelin WG (EPA Reg. No. 70051-66) Label submitted for Bt reregistration !' . As part of the reregistration ofBt microbial pesticides, the Agency has issued a stamped approved label for each reregistered product. Part of the labeling that was required for reregistrationwas an Environmental Hazards statement containing language to protect endangered or threatened . After finalizing reregistration of the subject product, the Agency was made aware that registrants were given an erroneous version of the Environmental Hazard statement to include on product labels. .The correct statement should read as follows:

"This product must not be applied aerially within 1/4 mile of any habitats of endangered or threatened Lepidoptera. No manual application can be made within 300 feet of any threatened or endangered Lepidoptera." . .

In light of this error, EPA has re-stamped the label forthe subject product with the corrected Environmental Hazards text. A copy of the label is enclosed for yoUr records. If you have any questions, please contact Alan Reynolds of my staff at (703) 605-0515 (e-mail: [email protected]).

Sincerely,

Sheryl Reilly, Ph.D., Branch Chief Microbial Pesticides Branch (7511P) Biopesticides and Pollution Prevention Division

Enclosure

CONCURRENCES' SYMBOL .. '/ S"lj () '. SURNAME ~ ··4····· ·lJ..~·: ...... ~ ...... :...... ~ ...... :...... •••• ~ / ;){~J' ••••••••••••••••••••••••••••••••• ,...... ••••••••••••••••••••• ••••••••••••••••••••• . DATE .... (IL~/.flY:; . '...... ,~; ...... •..

EPA Fonn 1320-1A (1/90) Printed on Recycled, Paper OFF.lCIAL FILE COpy

"U.S. Government Printing office: 2005 206-899 (mac) ( ]avelin®wG

BIOLOGICAL INSECTICIDE For Control of Pests of Vegetables, Fruit and Field Crops OMRr ,~ FOR ORGANIC PRODUCTION •••0.___ w ••.• 1nsIItuto Active Ingredient: : Bacillus thuringiensis, subspecies kurstaki strain SA-11 solids, EPA Reg. No. 70051-66 spores and Lepidopteran active toxins' ...... ;...... 85:0% EPA Est. No, 70051-CA-001 Other Ingredients: ...... ~ ...... 15.0% Lot No.: TOTAL 100.0oio 'The percent active ingredient does not indicate product performance and pOtency measurements are not federally standardized. KEEP OUT OF REACH OF CHILDREN' CAUTION See additional precautionary statements

FIRST AID If on skin or clothing: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. If hi eyes: Hold eye open and rinse 'slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. Manufactured by If inhaled: Move person to fresh air. If person is not breathing, call 911 or an Certis USA, L.L:C. ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. 9145 Guilford Road, Suite 175 9all a poison control center or doctor for treatment advice. Columbia, MD 21046 Have the prOduct container or label with you when calling a pOison control center or doctor, or going for treatment. Hot Line 'Number: 1-800-255-3924. CE,TIS

PRECAUTIONARY,STATEMENTS User Safety Recommendations: HAiARDSi6 tilJMANS:' Users should: AND DOMESTIC , . .' ," . • Wash hands before eating, drinking, chewing gum, using CAUTION tobaCCO or using the toilet. Causes moderate eye irritation. Prolonged or frequently repeated • Remove clothing immediately if pesticide gets inside, Then skin contact may Cause allergic reaciions in some individuals. Avoid wash'thoroughly and put 01') clean clothing. contact with 'eyes or clothing. Wash thoroughly with soap and water • Remove PPE immediately after handling this product, Wash after hall,dJing., , ' the outside of gloves before removing. As soon as possible, Personal Protective Equipment: . wash thoroughly and change into clean clothing. Applicator~ arid other handlers must wear: • Long-sl~eved shirt arid'iong pants Environmental Hazards • Waterpr\>of gloves Do not apply directly to water, or to areas where surface water is • Shoes p'lus sOckS, present or to intertidal areas below the mean high water mark. Do • Mixers/loaders and applicators must wear a dust/mist filtering not contaminate water when cleaning equipment or disposing of respirator meeting NIOSH standards of at least N-95, R-95, 0r P­ equipment washwaters. ;G5. 'Repeated exposure to high concentrations of microbial proteins This product must not be applied aerially within 1/4 mile of any :can cause ,allergic sensitization. habitats of endangered or threatened Lepidoptera. No manual iFolioW manufacturer?s instructions for cleaning! maintaining PPE. , application can be made within 300ft. of any threatened or endangered 'If, flO ,such instructions for washables exist, use detergent and hot Lepidoptera: .w~ter.,;Keepand WElsl;! PPE separately from' other laundry. DIRECTIONS FOR USE ,Engineering 'CoritrolsS,atements: It is a violation of Federal law to use this product in a manner ;When' haridfersuse dosed systems, enclosed cabs, or aircraft in a inconsistent with'its labeling. . manner.that meets the requirements listed in the Worker Protection For any reqUirements SPecific to your State orTribe, consult the :,Standard (WPS) for agricultural pesticides [40 CFR 170.240 (d) (4- agency responsible for pesticide regulation. '6)l, the handler PPE requirements may be reduced or modified as 'specified in the WPS: . Prosper with pesticides by using them properly! Read and follow label directions.' This labeling must be in the possession of the user at the time of . the pesticide application. '

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advisable to test physical compatibility by mixing all components in Agricultural Use Requirements: a small container in proportionate quantities. Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170. This Application Instructions Standard contains requirements for the protection of agricultural Avoiding spray drift at the application site is the responsibility of the workers on farms, forests, nurseries, and greenhouses, and applicator. The interaction of many equipment-and-weather-related handlers of agricultural pesticides. It contains requirements factors determine the potential for spray drift: The applicator and for training, decontamination, notification. and emergency the grower are responsible for considering all these factors when assistance. It also contail)S specific instructions and exceptions making decisions, pertaining to the statements on this label about personal - protective equipment (PPE), and restricted-entry interval: The Ground Application requirements in this box only apply to uses of this product that Unless otherwise stated, use the application rate amount of JAVELlN® are covered by the Worker Protection Standard. WG in a minimum of 20 gallons of water per acre depending on type of crop and requirements of state regulations. If lower volumes Do not apply this product in a way that will contact workers or are used, proper application equipment must be used to insure other persons, either directly or through drift. Only protected adequate coverage,' Thorough and uniform crop coverage is required handlers may be in the area during application. ' for adequate insect control. Do not enter or allow worker entry into treated areas during' the restricted entry interval (REI) of 4 hours. Aerial Application 'PPE required for early entry to treated areas that is permitted Use application rate amount of JAVELlN® WG in at least 3 gallons under the Worker Protection Standard and 'that involves contact of water per acre. Applications at higher water volumes have with anything that has been treated, such as plants, soil, or demonstrated improved control of targeted pests. Apply early water is: morning or evening when air is calm. • Coveralls • Waterproof gloves , CONTROLLED • Shoes plus socks When used as directed, JAVELlf.J® WG will control the following insects. NOTICE: Read "Limitation of Warranty and Limitation of Liability" 'on ttie container or in this Directions for Use section before buying Common Name Scientific Name or using. If terms are not acceptable, return at once, unopened. Alfalfa caterpillar Colias eurytheme (Boisduval) i . Almond Cadra cautella (Walker) Unless specifically stated; do not apply this product through any Armyworm Pseudaletia unipuncta (Haworth) type of irrigation system' ' Artichoke plume moth, P/atyptilla carduidacty/a (Riley) ~JAVELlf\I~ WG is ii biol~gicai insecticide for the control of Bagworm Thyridopteryx ephemeraeformis ,Iepidopterol!s larvae (see Application Rates section). (Haworth) Banana skipper Erionota thrax(Haworth) JAVELlN® WG attacks the larval gut and must b'e ingested by the Bertha armyworm Mamestra configurata 'insect to be effective, • . Blueberry leafrollers various jAVELiN®' WG 'r,;ay be applied up to and on the day of harvest. Blueberryspanworm Itame argillacearia (Pack.) i .', '.,.! j ; Bollworm Helicoverpa zea (Boddie) ;GENE~AL USEINST~UCTIONS Califomia oak moth Phryganidiacalifornica (Packard) ,For mostconsist~ritconlrol, apply at first sign of newly hatched' Cherry fruitworm Grapholita packardi (Zel/er) ;worms(1st'Euid 2ndinstar laniae). Instructions'for specific crops cutworm Xylomyges curialis 'are located in the ADDITIONAL INSTRUCTION sections under Codling moth Cydia pomonella (Linnaeus)

)APPLICATiON RATES:< ' Cotton leafperforator Bucculatrix thurberiella (Busck) 'Reapply as necessary under a pest managemeni program that Cotton leafworm Alabama argillacea (Hubner) 'inCludes close scouting. ' Cutworm various, family Noctuidae 'If rapidk~ockdo"";n of heavy worm or non-Iepidopterous populatio~s Diamondback 'moth Plutella xy/ostel/a (Linnaeus) is necessary,)ncILide an.'effective contact insecticide in combination Douglas-fir tussock moth Orgyia pseudotsugata with JAVELlN® WG. (McDunnough) Elm spanworm subsignaria (Hubner) ;For'heavy worm use the higher JAVELlN® WGrate. irifes~ations, European corn borer Ostrinia nubilalis (Hubner) ~DLjring situations of dense foliage and/or rapid growth, increasing Fall cankerworm A/sophila pometaria (HarriS) :water carn'er volumes will provide better crop coverage and improve Fall webworm Hyphantria cunea (DrurY) V'!.G ' 'JAV~

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Common Name Scientific Name Omnivorous leaftier Cnephasia longana (Haworth) Crops LbsJAcre Orange tortrix Argyrotaenia citrana (Fernald) Orangedog Papilio cresphontes (Cramer) Garlic, Green Onions, Greens (Dandelion, Oriental fruit moth Grapholita molesta (Busck) Turnip, Mustard, Beet, China), Herbs (BaSil, Pandemis leafroller Pandemis pyrusana Cilantro, Dill, Oregano, Thyme, etc.), twig borer Anarsia lineatella (Zeller) Horseradish, Kale, KO.hl Rabi, Leeks, Pecan nut case bearer (Neunzig) Lettuce (Endive, Romaine, Head Lettuce, . Redbanded leafroller Argyotaenia velutinana (Walker) . Escarole, Butter CrunCh, Leaf, etc.), Redhumped caterpillar Schizura concinna (J.E. Smith) Melons (Cantaloupe, Crenshaw, Honeydew, Rindworm complex various Muskmelon, Watermelon, etc.), Okra, Onions, Roughskinned cutworm Athetis mindara (Barnes & Parsley, Parsnips, Peas, Peppers, Potatoes, McDunnough) Pumpkins, Radishes; Rutabaga, Salsify, Saltmarsh caterpillar Estigmene acrea (Drury) Spinach, Squash (Summer and Winter), Sod webworm Crambus mutabilis Sweet Corn, Sweet Potatoes, Swiss Chard, Southwestemcom borer Diatraea grandiosella (Dyar) Table Beets,Tomatoes, Turnip Root, Spotted cutworm Xestia spp. Watercress, Yams Spring cankerworm Paleacrita vernata (Peck) ADDITIONAL INSTRUCTIONS: Spruce budworm Choristoneura fumiferana (Clemens) Apply as necessary to maintain control. Tent caterpillar various, family Lasiocampidae . Tobacco budworm Helicoverpa virescens (Fabricius) FIELD CROPS Tobacco homworm MandiJca sexta (Linnaeus) . Alfalfa (Hay and Seed), Sudan Grass, 0.25-1.50 Tomato pinworm Keiferia Iycopersicella (Walsingham) Hay Crops & Other Forage Crops Tropical sod webworm Herpetogramma phaeopteralis (Guenee) ADDITIONAL INSTRUCTIONS: Tufted apple bud moth Platynota idaeusalis (Walker) Under conditions of rapid plant growth and Variegated leatroller " Platynota flavedana (Clemens) rapidly increaSing armyworm populations Velvetbean caterpillar Anticarsia .gemmatalis (Hubner) (10 worms or greaterper 180· sweep) use the Westem tussock moth Orgyia vetusta (Boisduval) highest rate. Against heterogenous worm populations, where 4th and 5th instars are present, and continuous egg laying is 'occurring, RATE SELECTION CONSIDERATIONS applications may provide variable control. Under Application rates are typically given as a range: these conditions, the addition of a contact . insecticide in combination with JAVELlN® WG . Lower rate ranges may be desired when tank mixing with contact is recommended. The addition of a spreader insecticides labeled for worm control or under conditions of light stickerto JAVELlN® WG may provide improved worm infestations or when uniformly small worms we present. performance. Medium rate ranges may be desired when multiple worm life stages are present, continuous egg hatches are occurring or young or light . Canola and Evening Primrose 0.12-1.50 armyworm infestations exiSt. ADDITIONAL INSTRUCTIONS: Upper rate'ranges may be desired for heavy worm infestations, Apply as necessary to maintain control. m~ture (larger) worms or for .moderate to heavy infestations of Dry Beans and Peas, Lentils, Mint, Peanuts, 0.25-1.50 armyworm, bollworm, or other difficult to control worm species. Rice, Safflower, Soybeans, Sugar Beets, Unless otherwise stated,use the application rate amount of JAVEL1N® Sunflower, Sorghum WG .in a minjmum of 20 gallons of water per acre depending on ADDITIONAL INSTRUCTIONS: . type of crop and· requirement of state regulations. Lower volumes Apply as necessary to maintain control. maybe used, but proper application equipment must be used to insure·adequate coverage. Thorough and uniform crop coverage Field Corn, Pop Corn, Seed Corn 0.50-1.50 is required for a~equate insect control. . ADDITIONAL INSTRUCTIONS: Make initial application when economically APPLICATION RATES damaging populations exist. Repeat as necessary to maintain control. Applications Crops' LbsJAcre must be made to early instars prior to entering VEGETABLE CROPS the ear or plant. .

Artichokes 0.50-1.25 . Hops 0.25-1.00 ADDITIONAL INSTRUCTIONS: ADDITIONAL INSTRUCTIONS: Apply in a minimum of 100 gal. of water per acre Apply as necessary to maintain control. with a spray interval of 10 days or less. Begin treatment as soon as possible after hatching Apply 1 Ib/A fn combination with ASANA® XL, and before larvae are protected by leaf folds. AMBUSH®, or SUPRACIDE@ 25-W aerially to aid in resistance management of the artichoke Jojoba 0.50-1.00 plume moth. Use and follow all label directions ADDITIONAL INSTRUCTIONS: of the tank mix partner regarding application, Apply in a minimum of 50 gallons of water per timing,. gallonage, and schedules. acre by ground equipment or a minimum of 10 gallons of water by aerial equipment: Thorough Asparagus, Beans, (Green, Lima, Mung), 0.12-1.50 coverage of foliage is essential and dictates the Broccoli; Broccoli Raab (Rapinl), minimum spray volumes necessary. Brussels,Sprouts, Cabbage, Cardoon, Carrots, Cauliflower,Cei,erlac, Celery, Chick Peas, Small Grains 1 .00-1.50 Chinese Brocc;:oll, Chinese Cabbage, Collards, ADDITIONAL INSTRUCTIONS: Cucumb~rs, Dry Bulb Onions, Eggplants, Apply as necessary to maintain control. 3 ( (

Crops LbsJAcre Crops LbsJAcre

Tobacco 0.12-1.25 Bananas 0.50-1.00 ADDITIONAL INSTRUCTIONS: ADDITIONAL INSTRUCTIONS: Apply as necessary to maintain control. Hawaii only. Use calibrated ground equipment with adequate water·to Cotton 0.50-1.50 apply to point of runoff. Including Arizona and California Early and Mid-Season Citrus 0.25-1.50 ADDITIONAL INSTRUCTIONS: ADDITIONAL INSTRUCTIONS: Repeat as necessary throughout season Use 50-600 gallons of water per acre when to maintain control. If egg laying frequency using ground equipment and 10 gallons of indicates future moderate to heavy worm . water minimum per acre by air.(Amorbia populations, time application spray to [Mexican leafrollerjis suppressed only.) coincide with the 2nd instar larvae. During periods of high temperatures, worms will Blu~berries, Caneberries, 0.25-1.00 progress through 1st and 3rd instars very Currants, Kiwi rapidly and early application timing is ADDITIOt:JALINSTRUCTIONS: necessary for control. Apply by ground or aerial equipment using enough water to provide adequate coverage. To be effective, JAVELlN® WG spray mu~t be deposited at the larval feeding site. Begin treatment as soon as possible after hatChing. Fo(leafroliers, apply before When plant cover is dense and worms are feeding in the lower 2/3 portion of the plant, larvae are protected by leaf folds. aerial application of JAVELlN®WG may not Grapes 0.50-1.25 provide adequate control. ADDITIONAL INSTRUCTIONS: For the suppression of light to moderate Apply by ground equipment in up t6 200 infestations, apply at first sign of egg-laying gallons total spray per acre to obtain or newly-hatched worms (1 st instar larvae). thorough coverage of leaf surfaces. Start treating as so.o'n as possible after hatching 0.25-1.25 Except Arizona and California _ and before larvae are protected by leaf folds. Early. . . ADDITIONAL INSTRUCTIONS: Almonds, Apricots, Cherries 0.25-4.00 For early season' management of Filberts, Nectarines, Helicoverpa and Heliothis species. Initiate Pecans, Persimmons, Plums, applications when 50% of plants are at Pomegranates, Prunes, Walnuts pinhead square cotton stage, independent ADDITIONAL INSTRUCTIONS: of Helicoverpaand Heliothis egg and larval For leafrollers, start treating as soon as counts, or at 1st egg lay, whichever occurs possible after hatching and before larvae earlier. Continue. applications on 5-day are protected by leaf folds. spray interval up to synthetic pyrethroid Apply when caterpillars are actively spray window. For added control of Helicoveipa aildHeliothis, tank mixing of feeding (2nd-4th instar). JAVELlN®'WG with a labeled ovicide, such Application timing is very important for as; methomyl (0.125 lb. a.i.lacre), good casebearer suppression. Consult proferiofos (0.25 lb. ad.lacre), or thiodicarb your local university or extension agent for (0.125-0.25 Ib.a:Llacre)is recommended. information conceming specific modeling, that predicts egg lay, typical application dates, Read and follow all directions for use, and scouting techniques for your area. precautions and restrictions on tank mix JAVELlN® WG must be present at egg product labels. hatch for best control. Make application FRUIT, NUT& VINE CROPS when the majority of eggs are in the pink stage. For best control make two Apples and f,'ears 0.50-4.00 applications 7 days apart. If only one ADDiTIONAL INSTRUCTIONS: application is made, a minimum of 11b. Apply:when newly hatched larvae appear should be applied. and before leaves are. rolled. Continue . Melons (Also see vegetables) 0.50-0.75 applying as a part of the normal cover spray" program until pe!'.!t is adequately controlled. ADDITIONAL INSTRUCTIONS: Apply when caterpillars are actively feeding Apply at first sign of hatch before larvae enter (2nd~4th instars). fruit. Repeat as necessary to maintain control.

Avocados 0.50-1.25 Strawberries . 0.25-1.50 ADDITiONALJNSTRUCTIONS: ADDITIONAL INSTRUCTIONS: Apply as n~cessary to maintain control. Apply as necessary to maintain control. Use 20 Begin treatment as soon as possible after gallons water minimum per acre when using tiatchingand before larvae are protected ground equipment and 5 gallons water minimum by leaf folds . per acre by aircraft. . (Aniorbia [Mexican leafroller] is In'a tank mix with contact insecticides, rates as· ~uppressed only). low as 1/2 Ib.·of JAVELlN® WG may be used for the control of armyworm.

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Flowers and Ornamentals Crops LbsJAcre JAVELlNiI!I WG may also be used on ·flowers ~[ld ornamentals outdoors and in the greenhouse at a rate of SHADETREES.AND ORNAMENTALS 0.12-.1.25 0.25-1.50 lb. per 100 gallons of water for control of .Iisted (Including ) insects on this label. ADDITIONAL INSTRUCTIONS: Apply when leaf expansion reaches Guide for Small Spray Volume Mixing 40% to 50% as infestation warrants. Rate Conversion Rate" If eggs hatch over a long period of time, Lbs.! A ' Teaspoons! Gallon or if reinfestation occurs, spray about 14 --m- 1/2 days after first application. 1n 1 ' '1 2 Apply when most larvae are 3rd-4th instar. Also consider the opening of the bud cap to • Assumes Application to spray runoff. ensure foliage exposure. Apply after eggs have hatched and early instar larvae are . feeding on exposed foliage. STORAGE AND DISPOSAL. Do not contaminate water, food, or feed by storage TURF AND GRASS SEED PRODUCTION 1.00 and disposal. ADDITIONAL INSTRUCTIONS: , Storage Repeat as necessary throughout season to Store in original container in a cool, dry place maintain ·control. inaccessible to children and pets and away from STORED SOYBEANS, GRAINS heat and direcf.sunlight. Protect from freezing. (Indian Meal, Moth, Almond Moth) Storage at temperatures above 90° F may impair effeciiveness. . ADDITIONAL INSTRUCTIONS: To control and prevent Indian Meal Moth and Almond Pesticide Disposal . Moth infestations of stored soybeans and grains, prepare Pesticide; spray mixture, or rinse water that cannot a spray mixture which includes 1 gallon of water for every be used according to label instruction must be 1.5 oz: by weight of JAVELlN® WG. The spray mixture disposed of according to Federal, State, or Local may be applied either by treating the top 4 inches of grain procedures. as it is being augeredinto storage (applying 0.6 pint of iniXture pefbushel in thEl grain stream), or by treating the Container Disposal surface olgrain after it is in the bin. The Table below can Completely empty container into application be used as a gUide in determining the total amount of equipment. Triple rinse or equivalent. Then offer JAVELlN® WG needed according to bin diameter or the for recycling or reconditioning, or puncture and mJmber,of bushels to be treated. dispose of in a sanitary landfill or by incineration, or :Bin Surface 'Bushels JAVELlN@WG if allowed by State and Local authorities, by buming. If burned, stay out of smoke. ' Diameter Area (to 4 in. Rate , (ft.). ,(sCi, ft.) depth) (by weight) WARRANTY Certis USA, L.L.C, warrants that the material contained ~ ~ herein conforms to the description on the label and is 8 ,50 13 21 0,75 reasonably fit for the purposes referred to in the directions 113 30 50 1.75 12: for use. Timing and method of application, weather, 16 201 ,53 85 3.00 watering practices, nature of soil, the insect proble~, 20 ' 3H 84 120 4.25 condition of the crop, incompatibility with other chemicals 452 120 185 6.50 1,24" not specifically recommended, and other influencing factors 28 615 163 255 9.00 in the use of this product are beyond the control of the 32· 804 214 326 11.50 seller. Buyer assumes all risks of use, storage or handling To inslJre thOrough coverage when making applications of this material not in strict accordance with directions to t~egffiin surtace after it is in the bin, apply spray mixture given herein. NO OTHER EXPRESS OR IMPLIED , in ttiree (3) applications, Mix the grain with a scoop or WARRANTY OF THE FITNESS OR MERCHANTABILITY rake to' a'~epth 'offotir (4) inches after each application. IS MADE. , , StOred grain'may be tre~ted anytime, but for best results, treat grainat;thetime itisplaced into storage or shortly thereafter, orin the ·early spring prior to egg-laying. Full , season cO[1troi is: normally, experienced. Re-treat only if reinfestation occurs·.'

Fo.r'th~, pr~t~ctiO~ of bagged grain, apply spray mixt~re to entire grain mass, alid mix thoroughly pnor to bagging. REGISTERED TRADEMARKS JAvEtIN®WG a:t'~ oz. by weight per 10 gallons of water Ambush® is a registered trademark of Syngenta. ';"iiiireat'a~lPrOxima~ely .100 bushels. Asana® XL'iS a registered trademark of E.I duPont de Nemours and Co., Inc., ~reilted grain max be ,used at any time after treatment. Supracide® 25-W is a registered trademark of Gowan Company. JAVELlN® WG is a registered trademark of Certis USA, L.L.C.

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