i iS

UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY

WASHINGTON, D.C. 20460

NOTIFICATION

MAY 0 8 2012OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

John LublinkhofBell Laboratories, Inc.3699 Kinsman Blvd.Madison, WI 53704

Subject: Notification to add marketing claims for molesEPA Registration No. 12455-101Primary Brand Name: TalpiridSubmission Date: April 4, 2012

Dear Mr. Lublinkhof:>•

The Agency is in receipt of your Application for Pesticide Notification under PRN 98-10dated April 4, 2012 for product EPA Reg No. 12455-101 and finds that the action requested fallswithin the scope of PRN 98-10. The label submitted with the application has been stamped"Notification" and will be placed in our records. If you have any questions, please contact GeneBenbow at (703) 347-0235 or via email at benbow.gene@epa.gov.

Sincerely,

Gene BenbowWildlife BiologistInsecticide-Rodenticide BranchRegistration Division (7505P)

Pit*ft r*9<i instruction* on rmvmnm before comolftina form. Form Aoofoved. OMB No. 2070-OOSO Aoorovai axnirae 2-28-95

&EPAUnited States

Environmental Protection AgencyWashington. DC 20460

RegistrationAmendmentOther

OPP Identifier Number

Application for Pesticide - Section I1. Company/Product Number

12455-101

4. Company/Product (Name)Talpirid

2. EPA Product Manager

John HebertPMf

3. Proposed Classification

iNone Reetrieted

5. Name and Address of Applicant (Include ZIP Codtl

Bell Laboratories, Inc.3699 Kinsman Blvd.Madison, Wl 53704

6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3)(bid), my product is similar or identical in composition and labelingto:EPA Reg. No.

Check if this is a naw address Product Name

Section - II

Amendment - Explain below.

Resubmission in response to Agency letter dated.

Notification - Explain below.

| ] F,nal print* tab* in rep.on.NPT"=ICATIONAgency letter deted'Me Too* Application.

Other - Explain below.

MAY 0 8 2012

Explanation: Use additional page(s) if necessary. (For section I and Section II.)

Notification of label action per PRN 98-10. Informational subheading updated from: "MIMICS A MOLE'S NATURAL FOODSOURCE" to: MIMICS A MOLE'S NATURAL FOOD SOURCE, THE EARTHWORM. Alternate sub-heading added forGrub-shaped baits: "MIMICS A MOLE'S NATURAL FOOD SOURCE, THE GRUB." These are highlighted in yellow.

Section - III1. Material Thie Product Will B« Packaged In:

Child-Resistant Packaging

Yes

No

* Certification mustb» submitted

If •Yes" No. perUnit Packaging wgt. container

Water Soluble Packaging

Yes

No

If "Yes"Peckege wgt

No. percontainer

2. Type of Conteiner

MetalPlasticGlassPaperOther (Specify)

3. Location of Net Contents Information

[/I Lebel [ J Container

4. Size(s) Retail Container

20-100 grams5. Location of Label Directions

[ J ] Front label on container

0. Manner in Which Label is Affixed to Product LithographPaper gluedStenciled

Other

Section - IV1. Contact Point IComplats items directly below for identification of individual to be contacted, if necessary, to process this application I

NameJohn Lublinkhof

Title

Director of Regulatory AffairsTelephone No. (l.nJuoe Area Code1

608-241-0202

CertificationI certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.I acknowledge that any knowlinglly false or misleading statement may be punishable by fine or imprisonment orboth under applicable law.

'.. Signature

4. Typed I

John Lublinkhof

3. Title

Director of Regulatory Affairs

6. Oete

April 4, 2012

6. Dete Ar^' i ationReceived

(Stj.np*d)

EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete. White - EPA Fie Copy (original) Yeiow - Appflcant Copy

L A B O R A T O R I E S I N C

'

3699 Kinsman Blvd.Madison, Wisconsin 53704 USA

(608) 241-0202 • Fax: (608) 244-1056www.belllabs.com

\5

April 4, 2012

Mr. John Hebert PM#7 NOTIFICATIONU.S. EPA Office of Pesticide ProgramsInsecticide-Rodenticide Branch MAY 0 8 2012One Potomac Yard2777 S. Crystal DriveArlington, VA 22202

Subject: Talpirid, EPA Reg. No. 12455-101 Label Notification

Dear Mr. Hebert:

Bell Laboratories, Inc. respectfully submits a notification including updated informationalstatement(s) for Talpirid (EPA Reg. No. 12455-101) with the U.S. Environmental ProtectionAgency.

I have attached a CD using the XML format which includes the application form, draft label anda copy of this cover letter. The changes have been highlighted in yellow on the first page sub-headings.

If you have any questions or need any additional information, please do not hesitate to contactme at (608) 241-0202 Ext. 3138.

Sincerely,

John Lublinkhof, Ph.D.Director of Regulatory Affairs

CD attached

L Ct '

M- (S( '

._ON OUTER CONTAINER- COMPLETE LABEL

MAY 08 2012 TALPIRID

This Product May Only be Used to Control Moles in Manual,Below-Ground Applications.

MOLE BAIT

KILLS MOLES

EFFECTIVE AGAINST MOST COMMON MOLE SPECIES

MIMICS A MOLE'S NATURAL FOOD SOURCE, THE EARTHWORM

(Alternate language for package containing grub shaped baits only:)

MIMICS A MOLE'S NATURAL FOOD SOURCE, THE GRUB

READY TO USE

Scientifically designed and tested to mimic a mole's natural food source. Moles may consume a lethaldose in a single feeding, but it may take two or more days from the time of bait consumption for moles todie.

ACTIVE INGREDIENT:Bromethalin (CAS #63333-35-7): 0.025%INERT INGREDIENTS 99.975%

TOTAL 100.00%

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 for treatment advice.•Have 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.IF ON SKIN:•Wash with plenty of soap and water.

TREATMENT FOR PET POISONINGIf an animal eats bait, call veterinarian or 1-877-854-2494 at once.

NOTE TO PHYSICIAN OR VETERINARIANContains the nerve poison Bromethalin. This is not an anticoagulant type rodenticide. For humans oranimals ingesting bait and/or showing poisoning signs (such as muscle tremors, loss of hind limb use, or

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seizures for animals), limit absorption by either emesis or gastric lavage. Sublethal symptoms, if present,would be the result of cerebral edema and should be treated accordingly through administration of anosmotic diuretic and corticosteroid.

NET WEIGHT: Range: 20 - 100 g

Manufactured by: BATCH CODE:Bell Laboratories, Inc.3699 Kinsman Blvd.Madison, WI 53704e

EPA REG. NO. 12455-101 EPA EST. NO. 12455-WI-l

DIRECTIONS FOR USEIt is a violation of Federal law to use this product in a manner inconsistent with its labeling.

READ THIS LABEL: Read this entire label and follow all use directions and use precautions.

IMPORTANT: Do not expose children to this product or use it for any purpose other than to controlmoles. To help prevent accidents:

1. Store product not in use in locations out of the reach of children and pets.2. Follow all application directions and USE RESTRICTIONS on this label. Apply bait only in

underground runways of moles. Keep pets out of treated areas. Do NOT use this productabove ground.

3. Dispose of product container and unused or spoiled product as specified on label.

USE RESTRICTIONS: This product may only be applied at the use sites and by the applicationmethods indicated on this label. This product may only be used in lawns, parks, around homes, golfcourses, ornamental gardens, nurseries and other non-crop grassy areas to control eastern moles (Scalopusaquaticus), star-nosed moles (Conylura cristatd) or Scanapus spp. Bait must be applied directly intomoles' burrow systems. This bait must be applied underground in either main underground runways or insubsurface feeding tunnels. This bait may not be used above ground. Wear gloves when bait is handled.

SELECTION OF TREATMENT AREAS: The presence of moles may be indicated by a network ofsubsurface runways in the turf or by a series of conical mounds of earth pushed up from deep burrows.Subsurface runways are indicated by raised ridges of vegetation and soil caused by moles foraging forfood just below the soil surface. These runways are especially noticeable when the grass above them turnsyellow. Conical mounds may be indicative of the location of deeper main underground runways.

APPLICATION DIRECTIONS:(Qualifier statement for package containing worm shaped baits:) Remove and place worm shaped baitaccording to use directions below and ADDITIONAL GRAPHICS AND TEXT.)(Qualifier statement for package containing grub shaped baits: Remove and place grub shaped baitaccording to use directions below and ADDITIONAL GRAPHICS AND TEXT.)

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SUBSURFACE RUNWAYS: TALPIRID has been specially designed to mimic the natural food sourcesof the mole. To achieve maximum effect, TALPIRID should only be placed in areas used habitually bymoles for feeding.

ESTABLISHING INITIAL ACTIVITY: Use your finger, small wooden dowel or a narrow rod topuncture a hole in the top of subsurface runways. Be careful not to crush runways. Mark opened runwaysand revisit them 48 to 72 hours later. Runways that have had holes resealed within 72 hours should bebaited.

BAITING ACTIVE RUNWAYS: Make a hole in the top of the runway with a rod slightly larger than thediameter of the bait. Drop one worm into the runway, using the rod to push any exposed bait completelyinto the runway. Carefully reseal the runway with a small amount of dirt to exclude light. Repeat baitapplication every 5 to 10 feet of each active subsurface runway.

(Alternate language for package containing grub shaped baits only:)BAITING ACTIVE RUNWAYS: Make a hole in the top of the runway with a rod slightly larger than thediameter of the bait. Drop two grubs (one placement) into the runway, using the rod to push any exposedbait completely into the runway. Carefully reseal the runway with a small amount of dirt to exclude light.Repeat bait application every 5 to 10 feet of each active subsurface runway.

DETERMINING BAITING RESULTS: Five (5) to 7 days after bait application, check for mole activityusing the same procedure for determining initial activity. Return 48 to 72 hours later and retreat all activeruns.

MAIN UNDERGROUND TUNNELS AND CONICAL MOUNDS: Moles construct deeper runnelsthat are not visible from the surface. These deep tunnels systems are often marked by a series of conicalmounds (piles of dirt) 4 to 12 inches high formed when dirt is pushed to the surface when moles constructthese tunnels. To locate deep tunnels, push a probe, such as a broom handle, into the soil betweenmounds. When the probe enters a tunnel, the resistance on the probe will decrease rapidly. Mark openedtunnels and revisit them 48 to 72 hours later. Runways that have had holes resealed within 72 hoursshould be baited.

To bait deep tunnels, drop one TALPIRID worm through the probe hole, using the probe to push the baitcompletely into the tunnel. Cover the hole with a piece of sod, a small rock or a piece of newspaper toallow for visual inspection. Repeat bait application every 5 to 10 feet of each active deep tunnel andwithin 5 feet of each active conical mound. Check for the effects of treatment 5 to 7 days after baitapplication using the same procedure for determining tunnel location. Return 48 to 72 hours later andretreat all active tunnel systems.

(Alternate language for package containing grub shaped baits only:)To bait deep runnels, drop two TALPIRID grubs (one placement) through the probe hole, using the probeto push the bait completely into the tunnel. Cover the hole with a piece of sod, a small rock or a piece ofnewspaper to allow for visual inspection. Repeat bait application every 5 to 10 feet of each active deeptunnel and within 5 feet of each active conical mound. Check for the effects of treatment 5 to 7 days afterbait application using the same procedure for determining tunnel location. Return 48 to 72 hours later andretreat all active tunnel systems.

PRECAUTIONARY STATEMENTS

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Hazards to Humans and Domestic AnimalsCAUTION: Harmful if swallowed or absorbed through the skin. Keep away from children, domesticanimals and pets. Do not get in eyes, on skin, or on clothing.

All handlers (including applicators) must wear shoes, socks, and gloves. Any person who retrievescarcasses or unused bait following application of this product must wear waterproof gloves.

User Safety RequirementsFollow manufacturer's instruction for cleaning/maintaining PPE. If no such instructions for washables,use 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.

For consumer size products 1 Ib. or less:Replace "All handlers gloves." and the User Safety Requirements with:

Anyone handling baits must wear gloves. Wash thoroughly with soap and water after handling and beforeeating, drinking, chewing gum, or using tobacco.

Prolonged or frequent repeat skin contact may cause allergic reactions in some individuals

Environmental HazardsThis product is extremely toxic to mammals and birds. Dogs and other predatory and scavengingmammals and birds might be poisoned if they feed upon animals that have eaten this bait. Do not applydirectly to water.

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 childrenand pets. Keep containers closed and away from other chemicals.PESTICIDE DISPOSAL: Wastes resulting from the use of this product may be placed in trash ordelivered to an approved waste disposal facility.CONTAINER HANDLING: Nonrefillable container. Do not reuse or refill this container. Offer forrecycling, if available. Dispose of empty container by placing in trash, at an approved waste disposalfacility or by incineration.

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 are contrary to label instructions.

Alternate Storage and Disposal Language for packaging intended solely for household consumer use:

STORAGE AND DISPOSALDo not contaminate water, food or feed by storage or disposal.STORAGE: Store only in original container in a cool, dry place inaccessible to children and pets. Keepcontainers closed and away from other chemicals.

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DISPOSAL: If empty: Nonrefillable container. Do not reuse or refill this container. Place in trash oroffer for recycling if available. If partially filled: Place in trash or call your local solid waste agency fordisposal instructions. Never place unused product down any indoor or outdoor drain.

15

INNER CONTAINER - ABBREVIA TED LABEL

TALPIRIDThis Product May Only be Used to Control Moles in Manual,

Below-Ground Applications.

KEEP OUT OF REACH OF CHILDREN

CAUTIONSee outer container for additional precautionary statements.

ACTIVE INGREDIENT:Bromethalin (CAS #63333-35-7): 0.025%INERT INGREDIENTS 99.975%

TOTAL 100.00%

FIRST AIDHAVE LABEL WITH YOU WHEN OBTAINING TREATMENT ADVICE

IF SWALLOWED:•Call a poison control center, doctor, or 1-877-854-2494 immediately for treatment advice.•Have 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.IF ON SKIN:•Wash with plenty of soap and water.

TREATMENT FOR PET POISONINGIf an animal eats bait, call veterinarian or 1-877-854-2494 at once.

NOTE TO PHYSICIAN OR VETERINARIANContains the nerve poison Bromethalin. This is not an anticoagulant type rodenticide. For humans oranimals ingesting bait and/or showing poisoning signs (such as muscle tremors, loss of hind limb use, orseizures for animals), limit absorption by either emesis or gastric lavage. Sublethal symptoms, if present,would be the result of cerebral edema and should be treated accordingly through administration of anosmotic diuretic and corticosteroid.

DIRECTIONS FOR USEIt is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

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See outer box forfull "DIRECTIONS

FOR USE" text.See outer box forfull "STORAGE

AND DISPOSAL"

Bell Laboratories, Inc.3699 Kinsman Blvd.Madison, WI 53704

text.

NET WEIGHT: 10-50g

INDIVIDUAL SALE IS PROHIBITED BY LAW

Manufactured by:

EPA REG. NO. 12455-101 EPA EST. NO. 12455-WI-l

NOTE: MUST BE USED UNDERGROUND

OPTIONAL MARKETING STATEMENTS FOR WORM SHAPED BAIT:

6 Placements6 Worms - 1 Worm Per Placement8 Placements8 Worms - 1 Worm Per PlacementContains 20 worm shaped baits (TWO Individually Sealed Trays of 10)Worm FormulaWorm Shaped BaitsAvailable Exclusively From

OPTIONAL MARKETING STA TEMENTS FOR GRUB SHAPED BAIT:4 Placements8 Grubs - 2 Grubs Per PlacementGrub FormulaGrub Shaped BaitsAvailable Exclusively From

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ADDITIONAL GRAPHICS AND TEXT FOR WORM SHAPED BAIT:

Typical Mole Damage

Other mole baits have been developed on the premise that moles are similar to rats and mice, when in reality moles areinsectivores (insect eaters). Moles readily consume earthworms, and when available, grubs. In fact, more than 90% of amole's average daily dietary requirements are from earthworms and grubs.

Thousands of hours of groundbreaking laboratory and field research have gone into the product you are holding. Talpirid hasbeen carefully designed to mimic a mole's most common natural food source - earthworms and grubs. Moles may consume alethal dose in a single feeding, but it may take two or more days from the time of bait consumption for moles to die.

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1. Verify Active RunwaysUse your finger, small wooden dowel or anarrow rod to puncture a hole in the top ofsubsurface** runways. NOTE: Be careful tonot crush runway.

Mark opened runways andrevisit them 48-72 hours later.Runways that have had holesresealed within 72 hours shouldbe baited. (See Step 2)

2. Bait Active RunwaysMake a hole in the top of the runway with arod slightly larger than the diameter of thebait.

Drop one worm into theopening, ensuring that the wormis completely in the runway. Nopart of the worm should beexposed

Carefully reseal by pinching holeclosed. If not possible, cover witha small rock. Repeat baitapplication every 5-10 feet ofactive runway

-

3. Determine Baiting ResultsFive to seven days after application, check formole activity using the same procedure fordetermining initial activity. Return 48-72hours later and retreat all active runs.

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(2 »s

** Deep tunnel/mound systems require a slightly different procedure. See bottom of package for details.

NOTE: All properties are susceptible to recolonization. However, properties near woods, fields,streams/lakes, etc. are especially prone to this. These areas will have to be continually monitored andretreated if activity returns.

To bait deep tunnels, drop one TALPIRID worm through the probe hole, using the probe to push the baitcompletely into the tunnel. Cover the hole with a piece of sod, a small rock or a piece of newspaper toallow for visual inspection. Repeat bait application every 5 to 10 feet of each active deep tunnel andwithin 5 feet of each active conical mound. Check for the effects of treatment 5 to 7 days after baitapplication using the same procedure for determining tunnel location. Return 48 to 72 hours later andretreat all active tunnel systems.

ADDITIONAL GRAPHICS AND TEXT FOR GRUB SHAPED BAIT:

Typical Mole Damage

Other mole baits have been developed on the premise that moles are similar to rats and mice, whenin reality moles are insectivores (insect eaters). Moles readily consume earthworms, and whenavailable, grubs. In fact, more than 90% of a mole's average daily dietary requirements are fromearthworms and grubs.

Thousands of hours of groundbreaking laboratory and field research have gone into the product you

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are holding. Talpirid has been carefully designed to mimic a mole's most common natural foodsource - earthworms and grubs. Moles may consume a lethal dose in a single feeding, but it maytake two or more days from the time of bait consumption for moles to die.

1. Verify Active RunwaysUse your finger, small wooden dowel or anarrow rod to puncture a hole in the top ofsubsurface** runways. NOTE: Be careful tonot crush runway.

Mark opened runways andrevisit them 48-72 hours later.Runways that have had holesresealed within 72 hours shouldbe baited. (See St

2. Bait Active RunwaysMake a hole in the top of the runway with arod slightly larger than the diameter of thebait.

Drop two grubs (one placement)into the opening, ensuring thatthe grubs are completely in therunway. No parts of the grubsshould be exposed.

Carefully reseal by pinching holeclosed. If not possible, cover witha small rock. Repeat baitapplication every 5-10 feet ofactive runway.

3. Determine Baiting ResultsFive to seven days after application, check formole activity using the same procedure fordetermining initial activity. Return 48-72hours later and retreat all active runs.

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** Deep tunnel/mound systems require a slightly different procedure. See bottom of package for details.

NOTE: All properties are susceptible to recolonization. However, properties near woods, fields,streams/lakes, etc. are especially prone to this. These areas will have to be continually monitored andretreated if activity returns.

To bait deep tunnels, drop two grubs (one placement) through the probe hole, using the probe to push thebait completely into the tunnel. Cover the hole with a piece of sod, a small rock or a piece of newspaperto allow for visual inspection. Repeat bait application every 5 to 10 feet of each active deep tunnel andwithin 5 feet of each active conical mound. Check for the effects of treatment 5 to 7 days after baitapplication using the same procedure for determining tunnel location. Return 48 to 72 hours later andretreat all active tunnel systems.

ADDITIONAL GRAPHICS WITHOUT TEXT FOR WORM SHAPED BAIT:

ADDITIONAL GRAPHICS WITHOUT TEXT FOR GRUB SHAPED BAIT:

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Version 040412

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