epa reg date of us environmental issuance...2012/07/26 · norway rats roof and hous e mic may...
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![Page 1: EPA Reg Date of US ENVIRONMENTAL Issuance...2012/07/26 · Norway rats roof and hous e mic may consum a lethal dose in one night s»fe&dm£ W1th first ACCEPTED ,,„ 2g m ACTIVE INGREDIENT](https://reader036.vdocuments.site/reader036/viewer/2022081411/60a9c74116e6de6baa24e86c/html5/thumbnails/1.jpg)
US ENVIRONMENTALPROTECTION AGENCY
Office of Pesticide ProgramsRegistration Division (7505P)1200 Pennsylvania Ave N W
Washington D C 20460
NOTICE OF PESTICIDEX Registration
Reregistration(under FIFRA as amended)
EPA RegNumber
12455 139
Date ofIssuance
JUL 26 2012
Terms of Issuance
Unconditional
Final® Soft Bait
Name and Address of Registrant (include ZIP Code)
Bell Laboratories pV Q flon3699 Kinsman BlvdMadison Wl 53704
T$i * '
Attention Dr John Lublmkhof SO
j f * T.** ffy> Is' <- i<r i 4 / j> ^ t < r ^ ^ f*Note Change's m?|abe.ling differing in substance from that accepted in connection with this registration^ymust Ue submitted to a*hd%ccepted by the Registration Division pnoi to usfj of the label irj^commerc^^ *$^Irf'any^.co^sgondence^on this pfcifduct alvrayl refer^td the a&we^E^^elgjstratiomnuijiJer^ ^ ^ ^-^
On the basis of information furnished by the registrant the above named pesticide ishereby registered/reregistered under the Federal Insecticide Fungicide andRodenticide Act (FIFRA)
Registration is in no way to be construed as an endorsement or recommendation ofthis product by the Agency In order to protect health and the environment theAdministrator on his motion may at any time suspend or cancel the registration of apesticide in accordance with the Act The acceptance of any name in connection withthe registration of a product under this Act is not to be construed as giving theregistrant a right to exclusive use of the name or to its use if it has been covered byothers
EPA received an application for this new registration on January 5 2012 EPA grantsthis request under the authority of section 3(c)(5) of FIFRA provided that you
ature of Approving Official
JohnjHebertProol/jct Manager (01)Insecticide Rodenticide Branch
egistration Division (7505P)/ Insect
Date
JUL 26 2012
EPA Form 8570 6
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,
Page 2
Notice of Reregistration (continued)EPA Reg No 12455-139
A Submit and/or cite all data required for registration/reregistration of your productwhen the Agency requires all registrants of similar products to submit such data
B Make the following label changes before you release the product for shipment
1 revise your registration number to EPA Reg No 12455-139 and2 follow the Minimum Type Sizes for Final Printed Label enclosure
C Submit the following data within 18 months from the date of this registrationnotice
1 Storage Stability (830 6317) and2 Corrosion Characteristics (830 6320)
D Per 40 CFR 156 10(a)(6) submit one copy of your final printed labeling beforeyou release the product for shipment
As defined in 40 CFR 152 3 final printed labeling means the label or labelingof the product when distributed or sold Clearly legible reproductions or photoreductions will be accepted for unusual labels Note that a clean copy of themaster label in most cases does not meet the definition of final printed labeling
A copy of your label stamped Accepted is enclosed for your records
Reference to Website on Label
Should you wish to add a reference to the company s website on your label please beaware that the website becomes labeling under the Federal Insecticide Fungicide andRodenticide Act and is subject to review by the Agency If the website is false ormisleading the product would be misbranded and unlawful to sell or distribute underFIFRA section 12(a)(1)(E) 40 CFR 156 10(a)(5) list examples of statements EPA mayconsider false or misleading In addition regardless of whether a website ssreferenced on your product s label claims made on the website may not substantiallydiffer from those claims approved through the registration process Therefore shouldthe Agency find or if it is brought to our attention that a website contains false ormisleading statements or claims substantially differing from the EPA approvedregistration the website will be referred to the EPAs Office of Enforcement andCompliance Assurance
Confidential! Statement of Formula
The acceptable Confidential Statements of Formula (CSF) for this product are datedJune 20 2012 (Basic Formulation) All other versions are obsolete
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PageS
Notice of Reregistration (continued)EPA Reg No 12455 139
Terms/Conditions of Sale/Distribution (for Agricultural Building Only Use)
The registrant must not sell or distribute the product in a manner that results in sale instores oriented towards residential consumers (e g grocery drug hardware homeimprovement stores) The registrant may sell or distribute the product in a manner thatresults in sale in stores oriented towards agricultural consumers (i e farm agriculturaltractor stores)
This product may not be sold in packaging that holds less than 8 pounds of bait
Terms/Conditions of Sale/Distributions (for PCO Use)
The registrant must not sell or distribute the product in a manner that results in sale instores oriented towards residential consumers (e g grocery drug hardware homeimprovement stores) The registrant may sell or distribute the product in a manner thatresults in sale in stores oriented towards agricultural consumers (i e farm agriculturaltractor stores) and pest control operators
This product may not be sold in packaging that holds less than 16 pounds of bait
With the above revisions this product is in full compliance with the Agency s revisedMay 28 2008 Risk Mitigation Decision for Ten Rodenticides and is consistent with the1998 Rodenticide Cluster Reregistration Eligibility Decision (RED) document
If these conditions are not complied with the registration will be subject to cancellationin accordance with FIFRA section 6(e) Your release for shipment of the productconstitutes acceptance of these conditions
If you have any questions or comments regarding this letter please contact Mr DanPeacock by phone (703 305 5407) or e mail (peacock dan@epa gov)
Enclosures 1 Stamped Label2 Minimum Type Sizes for Final Printed Label3 Chemistry Acute Toxicity and Efficacy Reviews
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0124550013920120716PEST CONTROL OPERATOR USE LABEL
OUTER CONTAINER COMPLETE LABEL - PACKAGE WEIGHTS 16 LB OR GREATER
FINAL® SOFT BAIT
KILLS RA TS AND MICE
KILLS WARFARIN RESISTANT NORWAY RATS AND HOUSE MICE_, _oof rats and house mice may consume a lethal dose in one night s»fe&dm£ W1
rodents appearing five or six days after feeding begins nwOtrl tuNorway rats roof rats and house mice may consume a lethal dose in one night s»fe&dm£ W1th first
ACCEPTED ,,„ 2g m
ACTIVE INGREDIENT Under *e Federal Insecticide Fungicide,Brodifacoum (CAS #56073 10 0) o oc8f$£iodenticide Act as amended for theOTHER INGREDIENTS* 99 9975% pesticide registered under
100 0000%*Contams Denatomum Benzoate
KEEP OUT OF REACH OF CHILDREN
CAUTION
FIRST AIDHAVE LABEL WITH YOU WHEN OBTAINING TREATMENT ADVICE
If Swallowed Call a poison control center doctor or 1 877 854 2494 immediately fortreatment advice
Have a person sip a glass of water if able to swallowDo not induce vomiting unless told to do so by the poison control centeror doctor
NOTE TO PHYSICIANIf swallowed this material may reduce the clotting ability of the blood and cause bleeding If ingestedadminister Vitamin K] intramuscularly or orally Vitamin KI is antidotal at doses of 10 20 mg (notmg/kg) Repeat as necessary based on monitoring of prothrombin times
TREATMENT FOR PET POISONINGIf animal eats bait call veterinarian or 1 877 854 2494 at once
NOTE TO VETERINARIANAnticoagulant Brodifacoum For animals ingesting bait and/or showing poisoning signs (bleeding orelevated prothrombin times) give Vitamin KI at doses of 2 5 mg/kg If needed check prothrombin timesevery 3 days until values return to normal (up to 30 days) In severe cases blood transfusions may beneeded
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PEST CONTROL OPERATOR USE LABEL
See Back/Side Panel for First Aid and additional precautionary statements
NET WEIGHT16 Ib to 50 Ib containers
Statement required on label of inner containers containing less than 16 Ib of bait INDIVIDUAL SALEIS PROHIBITED BY LAW
Manufactured by BATCH CODEBell Laboratories, Inc3699 Kinsman BlvdMadison WI 53704e
EPA REG NO 12455 RGO EPA EST NO 12455 WI 1
DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labelingREAD THIS LABEL Read this entire label and follow all use directions and use precautions Use onlyfor the sites pests and application methods described on this label
IMPORTANT Do not expose children pets or nontarget animals to rodenticides To help to preventexposure1 Store unused product out of reach of children and pets2 Apply bait in locations out of reach of children pets domestic animals and nontarget wildlife or in
tamper resistant bait stations These stations must be resistant to destruction by dogs and by childrenunder six years of age and must be used in a manner that prevents such children from reaching intobait compartments and obtaining bait If bait can be shaken from bait stations when they are liftedunits must be secured or otherwise immobilized Stronger bait stations are needed in areas open tohoofed livestock raccoons bears or other potentially destructive animals or in areas prone tovandalism
3 Dispose of product container and unused spoiled or unconsumed bait as specified on this label
Note Bait stations are mandatory for outdoor above ground use Tamper resistant bait stations must beused if children pets non target mammals or birds may access the bait
USE RESTRICTIONSThis product may only be used to control Norway rats roof rats and house mice in and -within 100 feet ofman made structures constructed in a manner so as to be vulnerable to commensal rodent invasions and/orto harboring or attracting rodent infestations Examples of such structures include homes and otherpermanent or temporary residences food processing facilities industrial and commercial buildings trashreceptacles agricultural and public buildings transport vehicles (ships trains aircraft) docks and port ofterminal buildings and related structures around and associated with these sites Fence and perimeterbaiting beyond 100 feet from a structure as defined above is prohibited This product must not beapplied directly to food or feed crops
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PEST CONTROL OPERATOR USE LABEL
This product may also be used in alleys Do not place near or inside ventilation duct openings Do notcontaminate water food feedstuffs food or feed handling equipment or milk or meat handlingequipment or surfaces that come into direct contact with food When used in USDA inspected facilitiesthis product must be applied in tamper resistant bait stations Do not broadcast bait
Do not sell this product in individual containers holding less than 16 pounds of bait
Burrow baiting with Final® Soft Bait is prohibited
SELECTION OF TREATMENT AREAS Determine areas where rats or mice will most likely findand consume the bait Generally these areas are along walls by gnawed openings in or beside burrowsin corners and concealed places between floors and walls or in locations where rats or mice or their signshave been seen Protect bait from rain and snow Remove as much alternative food as possible
APPLICATION DIRECTIONSRATS Place 6 to 28 pouches [packs] [sachets] at intervals of 15 to 30 feet per placement in infestedareas Maintain an uninterrupted supply of fresh bait for at least 1 0 days or until signs of rat activityceaseMICE Place 1 pouch [pack] [sachet] per placement Space placements at 8 to 12 foot intervals ininfested areas Three pouches [packs] [sachets] may be needed at points of very high mouse activityMaintain an uninterrupted supply of fresh bait for at least 15 days or until signs of mouse activity ceaseFOLLOW UP Replace contaminated or spoiled bait immediately Wearing gloves collect and disposeof all dead exposed animals and leftover bait To prevent remfestation limit sources of rodent foodwater and harborage as much as possible If remfestation does occur repeat treatment Where acontinuous source of infestation is present establish permanent bait stations and replenish as needed
PRECAUTIONARY STATEMENTSHazards to Humans and Domestic AnimalsCAUTION Harmful if swallowed Keep away from children domestic animals and pets
All handlers (including applicators) must wear shoes plus socks and gloves Any person who retrievescarcasses or unused bait following application of this product must wear gloves
User Safety RequirementsFollow manufacturer s instruction for cleaning/maintaining PPE If no such instructions for washablesuse detergent and hot water Keep and wash PPE separately from other laundry Remove PPEimmediately after handling this product Wash the outside of gloves before removing As soon aspossible wash hands thoroughly after applying bait and before eating drinking chewing gum usingtobacco or using the toilet and change into clean clothing
ENVIRONMENTAL HAZARDSThis product is extremely toxic to mammals and birds Dogs cats and other predatory and scavengingmammals and birds might be poisoned if they feed upon animals that have eaten this bait This pesticide istoxic to fish Do not apply directly to water or to areas where surface water is present or to mtertidalareas below the mean high water mark Runoff also may be hazardous to aquatic organisms m wateradjacent to treated areas Do not contaminate water when disposing of equipment wash water or nnsate
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PEST CONTROL OPERATOR USE LABEL
STORAGE AND DISPOSALDo not contaminate water food or feed by storage or disposalPesticide Storage Store only in original container in a cool dry place inaccessible to children and petsKeep containers closed and away from other chemicalsPesticide Disposal Dispose of wastes resulting from the use of this product in trash or at an approvedwaste disposal facilityContainer Handling Nonrefillable container Do not reuse or refill this container [Plastic ] Offer forrecycling or reconditioning or puncture and dispose of in a sanitary landfill or by incineration In moststates burning is not allowed [Paper ] Dispose of empty container by placing in trash at an approvedwaste disposal facility or by incineration In most states burning is not allowed
WARRANTY To the extent consistent with applicable law seller makes no warranty expressed orimplied concerning the use of this product other than indicated on the label Buyer assumes all risk ofuse and/or handling of this material when such use and/or handling is contrary to label instructions
INDIVIDUAL PACKET LABEL
FINAL" SOFT BAITACTIVE INGREDIENTBrodifacoum (CAS #56073 10 0)OTHER INGREDIENTS
0 0025%99 9975%
1000000%KEEP OUT OF REACH OF CHILDREN
CAUTION
DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistentwith its labeling See outer package label for complete DIRECTIONS FORUSE including USE RESTRICTIONS
NET WEIGHT 0 53 oz (15 g)EPA Reg No 12455 RGO EPA Est No 12455 WI 1
INDIVIDUAL SALE IS PROHIBITED BY LAW
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AGRICULTURAL USE LABEL
OUTER CONTAINER - COMPLETE LABEL - PACKAGE WEIGHTS 8 LB OR GREATER
FINAL® SOFT BAITFor Use In and Around Agricultural Buildings Only
KILLS RA TS AND MICE
KILLS WARFARIN RESISTANT NORWAY RATS AND HOUSE MICENorway rats roof rats and house mice may consume a lethal dose in one night s feeding with first deadrodents appearing five or six days after feeding begins
ACTIVE INGREDIENTBrodifacoum (CAS #56073 100) 0 0025%OTHER INGREDIENTS* 99 9975%
100 0000%*Contams Denatomum Benzoate
KEEP OUT OF REACH OF CHILDREN
CAUTION
FIRST AID
HAVE LABEL WITH YOU WHEN OBTAINING TREATMENT ADVICEIF SWALLOWED
• Call a poison control center doctor or 1 877 854 2494 or 1 800 858 7378* immediately fortreatment advice
• Have a person sip a glass of water if able to swallow• Do not induce vomiting unless told to do so by the poison control center or doctor
* Also call this number for information on health concerns and pesticide incidents
NOTE TO PHYSICIANIf swallowed this material may reduce the clotting ability of the blood and cause bleeding If ingestedadminister Vitamin KI intramuscularly or orally as indicated in bishydroxycoumarm overdoses Repeatas necessary based on monitoring of prothrombm times
TREATMENT FOR PET POISONINGIf animal eats bait call veterinarian at once
NOTE TO VETERINARIANAnticoagulant Brodifacoum For animals ingesting bait and/or showing poisoning signs (bleeding orelevated prothrombm times) give Vitamin KI at doses of 2 5 mg/kg If needed check prothrombm timesevery 3 days until values return to normal (up to 30 days) In severe cases blood transfusions may beneeded
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AGRICULTURAL USE LABEL
See Back/Side Panel for First Aid and additional precautionary statements
NET WEIGHT8 50 Ib
Statement required on label of inner containers containing less than 8 Ib of bait INDIVIDUAL SALEIS PROHIBITED BY LAW
Manufactured by BATCH CODEBell Laboratories, Inc3699 Kinsman BlvdMadison WI 53704e
EPA REG NO 12455 RGO EPA EST NO 12455 WI 1
DIRECTIONS FOR USEIt is a violation of Federal law to use this product m a manner inconsistent with its labelingREAD THIS LABEL Read this entire label and follow all use directions and use precautions Use onlyfor the sites pests and application methods described on this label
IMPORTANT Do not expose children pets or nontarget animals to rodenticides To help to preventexposure
1 Store unused product out of reach of children and pets2 Apply bait in locations out of reach of children pets domestic animals and nontarget wildlife or
in tamper resistant bait stations These stations must be resistant to destruction by dogs and bychildren under six years of age and must be used in a manner that prevents such children fromreaching into bait compartments and obtaining bait If bait can be shaken from bait stations whenthey are lifted units must be secured or otherwise immobilized Stronger bait stations are neededin areas open to hoofed livestock raccoons bears or other potentially destructive animals or mareas prone to vandalism
3 Dispose of product container and unused spoiled or unconsumed bait as specified on this label
Note Bait stations are mandatory for outdoor above ground use Tamper resistant bait stations must beused if children pets non target mammals or birds may access the bait
USE RESTRICTIONSThis product may only be used to control Norway rats roof rats and house mice m and within 100 feet ofagricultural buildings and man made agricultural structures constructed in a manner so as to be vulnerableto commensal rodent invasions and/or to harboring or attracting rodent infestations Fence and perimeterbaiting beyond 100 feet from an agricultural structure as defined above is prohibited Do not use mhomes or other human residences This product must not be applied directly to food or feed crops
Do not place near or inside ventilation duct openings Do not contaminate water food feedstuffs food orfeed handling equipment or milk or meat handling equipment or surfaces that come into direct contact
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AGRICULTURAL USE LABEL
with food When used m USDA inspected facilities this product must be applied in tamper resistant baitstations Do not broadcast bait
Do not sell this product in individual containers holding less than 8 pounds of bait
Burrow baiting with Final® Soft Bait is prohibited
SELECTION OF TREATMENT AREAS Determine areas where rats or mice will most likely findand consume the bait Generally these areas are along walls by gnawed openings in or beside burrowsin corners and concealed places between floors and walls or in locations where rats or mice or their signshave been seen Protect bait from rain and snow Remove as much alternative food as possible
APPLICATION DIRECTIONSRATS Place 6 to 28 pouches [packs] [sachets] at intervals of 15 to 30 feet per placement in infestedareas Maintain an uninterrupted supply of fresh bait for at least 10 days or until signs of rat activityceaseHOUSE MICE Place 1 pouch [pack] [sachet] per placement Space placements at 8 to 12 foot intervalsin infested areas Three pouches [packs] [sachets] may be needed at points of very high mouse activityMaintain an uninterrupted supply of fresh bait for at least 15 days or until signs of mouse activity ceaseFOLLOW UP Replace contaminated or spoiled bait immediately Wearing gloves collect and disposeof all dead exposed animals and leftover bait To prevent remfestation limit sources of rodent foodwater and harborage as much as possible If remfestation does occur repeat treatment Where acontinuous source of infestation is present establish permanent bait stations and replenish as needed
PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION Harmful if swallowed Keep away from children domestic animals and pets
All handlers (including applicators) must wear shoes plus socks and gloves Any person who retrievescarcasses or unused bait following application of this product must wear gloves
User Safety RequirementsFollow manufacturer s instruction for cleaning/maintaining PPE If no such instructions for washablesuse detergent and hot water Keep and wash PPE separately from other laundry Remove PPEimmediately after handling this product Wash the outside of gloves before removing As soon aspossible wash hands thoroughly after applying bait and before eating drinking chewing gum usingtobacco or using the toilet and change into clean clothing
ENVIRONMENTAL HAZARDSThis product is extremely toxic to mammals and birds Dogs cats and other predatory and scavengingmammals and birds might be poisoned if they feed upon animals that have eaten this bait This pesticide istoxic to fish Do not apply directly to water or to areas where surface water is present or to mtertidalareas below the mean high water mark Runoff also may be hazardous to aquatic organisms m wateradjacent to treated areas Do not contaminate water when disposing of equipment wash water or rmsate
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AGRICULTURAL USE LABEL
STORAGE AND DISPOSALDo not contaminate water food or feed by storage or disposal
Pesticide Storage Store only in original container in a cool dry place inaccessible to children and petsKeep containers closed and away from other chemicalsPesticide Disposal Wastes resulting from the use of this product may be placed in trash or delivered toan approved waste disposal facilityContainer Handling Nonrefillable container Do not reuse or refill this container [Plastic ] Offer forrecycling or reconditioning or puncture and dispose of in a sanitary landfill or by incineration In moststates burning is not allowed [Paper] Dispose of empty container by placing in trash at an approvedwaste disposal facility or by incineration In most states burning is not allowed
WARRANTY To the extent consistent with applicable law seller makes no warranty expressed orimplied concerning the use of this product other than indicated on the label Buyer assumes all risk ofuse and/or handling of this material when such use and/or handling is contrary to label instructions
INDIVIDUAL PACKET LABEL
FINAL" SOFT BAITACTIVE INGREDIENTBrodifacoum (CAS #56073 10 0)OTHER INGREDIENTS
0 0025%99 9975%
100 0000%KEEP OUT OF REACH OF CHILDREN
CAUTION
DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistentwith its labeling See outer package label for complete DIRECTIONS FORUSE including USE RESTRICTIONS
NET WEIGHT 0 53 oz (15 g)EPA Reg No 12455 RGO EPA Est No 12455 WI 1
INDIVIDUAL SALE IS PROHIBITED BY LAW
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c r
OPTIONAL MARKETING STATEMENTS (For Pest Control Operator Use and Agricultural Use):
[Contains] [Includes] [With] Lumitrack™Easily secured [inside station]Extremely high melt point [stable at 200° +]For indoor and outdoor useKills rats and miceKills Norway rats, roof rats and house miceSoft baitSoft bait sachet[s]Soft bait pouch[es]Soft bait pack[s]Flexible baitFlexible] bait sachet[s]Flexible] bait pouch[es]Paste baitPaste bait sachet[s]Paste bait pouch [es]Paste bait pack[s]Pasta baitPasta bait sachet[s]Pasta bait pouch [es]Pasta bait packfs]May use in Protecta® bait stationsPalatable, oil based formulaSachetfs]15gSachet[s]15gPouch[es]15gPacks[s]
OPTIONAL PICTURES
FIN
071612
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