Transcript
Page 1: US EPA, Pesticide Product Label, BABOLNA BIO RS …€¦ · 26/10/2010  · Please contact us if you have any questions or need additional information. Peggy M.r Galloway Regulatory

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OCT 26 2010OFFICE OF

PREVENTION, PESTICIDES ANDTOXIC SUBSTANCES

Peggy M. GallowayRegulatory AgentBabolna Bioenvironmental Centre Ltd.c/o Landis International, Inc.P.O. Box 5126Valdosta, GAS 1603-5126

RE: Product Name: RS Methoprene TechnicalEPA Reg. No: 70062-2Application for Label Notification Dated September 28, 2010 to update storageand disposal statement per PR Notice 2007-4 and to update the name, address, netcontents and EPA registration number

Deai- Ms. Galloway:

The Biopesticides and Pollution Prevention Division is in receipt of your application forNotification under Pesticide Registration (PR) Notice 98-10 dated above. A preliminary screenof this request has been conducted for its applicability under PR Notice 98-10 and it has beendetermined that the action(s) requested falls within the scope of PR Notice 98-10. Our recordshave been duly noted, and the label submitted with this application has been stamped"Notification Accepted" and will be placed accordingly in our records.

If you have any questions concerning this action, please feel free to contact Ms. MenyonAdams at (703) 347-8496 or email at adams.menyonfojepa.gov.

Sincerely,

Linda Hollis, ChiefBiochemical Pesticides BranchBiopesticides and Pollution PreventionDivision (75IIP)

Intemet.Address (URL) • http://www.epa.govRecycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper

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cPlease read instructions on reverse before completing form.

r 2 4Form Apuioved. OMB No. 2070-0060. Approval expires 2-28-95

6EFAUnited States

Environmental Protection AgencyWashington, DC 20460

Registration

Amendment

Other

OPP Identifier Number

Application for Pesticide - Section I1. Company/Product NumberBabolna Bioenvironmental Centre Ltd./ 70062-2

4. Company/Product (Name)Babolna Bioenvironmental Centre Ltd./ MCSI RS-Methoprene Technical

2. EPA Product ManagerLinda Hollis, Branch Chief

PM # Biochemical Pesticides BranchBiopesticides & Pollution PreventionDivision

3.Restricted

None

5. Name and Address of Applicant (Include ZIP Code)Babolna Bioenvironmental Centre Ltd.c/o Landis InternationalP.O. Box5126Valdosta, GA 31603-5126

6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(i), myproduct is similar or identical in composition and labeling to:

Check if this is a new address

EPA Reg. No..

Product Name

Section - II

X

Amendment - Explain Below

Resubmission in Response to Agency letter dated.

Notification - Explain Below

Final printed labels in response toAgency letter dated _.

Notification Accepted"Me Too" Application

Other-Explain 56 2010Explanation: Use additional page(s) if necessary. (For Section I and Section II.) This notifi jy^wded 3rf JpBa{e''ofltn1e*~sTorage and disposalsection, net contents, and current address. This notification is consistent with the provisions of PR Notice 98-1*0 and EPA regulations at 40 CFR 152.46,and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice98-10 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14of FIFRA.

Section -1. Material This Product Will Be Packaged In:Child-Resistant Packaging

Yes

No

* Certification must besubmitted

Unit Packaging

Yes No

If 'Yes' UnitPackaging Wgt.

No. percontainer

Water Soluble Packaging

Yes No

If "Yes"Package Wgt.

No. percontainer

2. Type of ContainerMetal

Plastic

Glass

Paper

X Other (Specify) Phenolic eooxv resin

lined metal drum

3. Location of Net Contents Information

Label Container

4. Size(s) Retail Container

55.1,110.2 Ibs

5. Location of Label Directions

On label

On leaflet accompanying label

6. Manner in Which Label is Affixed to Product Lithographed_X Paper glued

StenciledOther

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

NamePeggy M. Galloway

TitleRegulatory Agent

Telephone No. (Include Area Code)(229) 247-6472

CertificationI certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.

I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or bothunder applicable law.

2. Si

4. Typed NamePeggy M. Galloway

3. TitleRegulatory Agent

5. DateSeptember 28, 2010

6. Dale ApplicationReceived

(Stamped)

EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete. White - EPA File Copy (original) Yellow • Applicant Copy

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u cINTERNATIONAL

R & D M A N A G E M E N T

September 28, 2010

Linda Hollis, Branch ChiefBiochemical Pesticides BranchBiopesticides & Pollution Prevention DivisionU.S. EPA Office of Pesticide Program (7504P)Document Processing Desk (NOTIF)One Potomac Yard, Room S49002777 S. Crystal DriveArlington, VA 22202-4501

SUBJECT: MCSI RS-Methoprene Technical, EPA Reg. No. 70062-2

Dear Ms. Hollis,

Please find enclosed the following documents on behalf of BABOLNA BIOENVIRONMENTALCENTRE LTD., for MCSI RS Methoprene Technical, EPA Reg. No. 70062-2:

• Application for Pesticide (EPA Form 8570-1).• One copy of "clean" draft labeling for MCSI RS Methoprene Technical.• One copy of "highlighted" draft labeling for MCSI RS Methoprene Technical.

The enclosed draft labeling reflects the current registrant address and net contents. Additionally, thestorage and disposal section of the label has been updated in compliance with PR Notice 2007-4.Changes made to the enclosed revised label comply with the requirements of PR Notice 98-10. Allchanges are highlighted in yellow background with additions in normal type-face and deletions instrikethrough.

Please contact us if you have any questions or need additional information.

Peggy M.r GallowayRegulatory AgentBABOLNA BIOENVIRONMENTAL CENTRE LTD.Enclosures: Identified Above

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3185 Madison Highway P.O. Box 5126 • Valdosta, Georgia 31603-5126 USA (229)247-6472 Fax (229) 242-1562 [email protected]

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MCSIRS-METHOPRENE TECHNICALFOR FORMULATION INTO INSECT GROWTH REGULATOR (IGR) PRODUCTS

ACTIVE INGREDIENT: Methoprene (Isopropyl (2E,4E)-(7RS) - I l-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) min. 99.0%

OTHER INGREDIENTS: 1.0%

100.0%

KEEP OUT OF REACH OF CHILDREN

CAUTIONPrecaution al usario: Si usted no lee en ingles, no use este producto hasta que la etiqueta haya sidoexplicado ampliamente.

FIRST AID

If Swallowed

If in Eyes

In On Skin OrClothing

If inhaled

Call poison control center or doctor for treatment advice.Do not induce vomiting unless told to do so by the poison control center or doctor.Have person sip a glass of water if able to swallow.Do not give anything by mouth to an unconscious person.Hold eye open and rinse slowly and gently with water for 15-20 minutes.Remove contact lenses, if present, after the first 5 minutes, the continue rinsing eye.Call a poison control center or doctor for further treatment advice.Take off contaminated clothing.Rinse skin immediately with plenty of water for 15-20 minutes.Call a poison control center or doctor for further treatment advice.

Move person to fresh air.It person is not breathing, call 911 or an ambulance, then give artificial respiration,preferably by mouth to mouth if possible.

• Call a poison control center or doctor for further treatment advice.

HOT LINE NUMBER - CHEMTREC (800) 424-9300(24 hours)

Have the product container or label with you when calling a poison control center or doctor or going for treatment.

See back panel for additional precautionary statements

EPA REGISTRATION NO. 70062-2 EPA ESTABLISHMENT NO. 70062-HUN-l

NET CONTENTS: 55.1, 110.2 Ibs (25, 50 kg) BATCH CODE:

Manufactured By:BABOLNA BIOENVfRONMEN TAL

CENTRE LTD.11 07 Budapest X.Szallas U.6Hungary

P.O. Box 5 126Valdosta,GA 3 1603-5126USA

Notification Acceptedottt: OCT 262010

Rcvfew:

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MCSI R5-METHOPRENE TECHNICAL

PRECAUTIONARY STATEMENTS

CAUTIONHAZARDS TO HUMANS AND DOMESTIC ANIMALS

May cause irritation of nose, throat, eyes and skin. Avoid contact with eyes, skin, and clothing. Washthoroughly with soap and water after handling.

ENVIRONMENTAL HAZARDS

Do not discharge effluent containing this product into lakes, steams, ponds, estuaries, oceans or otherwaters unless in accordance with the requirements of a National Pollutant Discharge EliminationSystem (NPDES) permit and the permitting authority has been notified in writing prior to discharge.Do not discharge effluent containing this product to sewer systems without previously notifying thelocal sewage treatment plant authority. For guidance, contact your State Water Board or RegionalOffice of the EPA.

DIRECTIONS FOR USE

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

Methoprene is an insect juvenile hormone analogue with activity against insect larvae. It can be used tocontrol species that are harmful mainly as adults (e.g. mosquitoes, flies, and fleas) or at high infestationrates (e.g. beetles, moths in stored products).

Babolna Bio RS-Methoprene Technical is for use only in the formulation of Insect Growth Regulator(IGR) products for use on agricultural crops, non-crop sites, ornamental plants and forest trees, processedor manufactured products, food-handling premises, pets and domestic animals and their man-madepremises, households, aquatic sites, and wide area and general indoor/outdoor treatments for commercialand industrial uses.

Products formulated from this technical material will require registration with the U.S.Environmental Protection Agency (EPA). Efficacy data will be required by the U.S. EPA for anyend-use product registered for control of pests that pose a threat to human health. 5-year efficacystudies will be required by the U.S. EPA for any end-use products registered as termiticides-, , ,

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MCSI RS-METHOPRENE TECHNICAL

STORAGE AND DISPOSAL

Do not contaminate water, food, or feed by storage or disposal.

PESTICIDE STORAGE: Store unused product in original container only in a cool, dry area out of thereach of children or animals.

PESTICIDE DISPOSAL: Wastes resulting from the use of this product may be disposed of on-site or atan approved waste disposal facility.

CONTAINER HANDLING: Nonrefillable container. Do not reuse or refill this container. Triple rinsecontainer (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remainingcontents into a container for mixing. Fill the container VA full with water. Replace and tighten closures.Tip container on its side and roll it back and forth, ensuring at least one complete revolution, for 30seconds. Stand the container on its end and tip it back and forth several times. Turn the container overonto its other end and tip it back and forth several times. Empty the rinsate into a container for mixingor store rinsate for later use or disposal. Repeat this procedure two more times. Then dispose of in asanitary landfill or by other approved State and local procedures. Offer for recycling, if available.

WARRANTY AND CONDITIONS OF SALE

Babolna Bioenvironmental Centre Ltd. warrants that the chemical composition of this product conformsto the chemical description on the label and is reasonably fit for the purpose stated on the label when usedin accordance with label directions under normal conditions of use. Seller makes no other warranty,express or implied, concerning the use of this product other than as indicated on the label. Buyer assumesall risk of use, storage or handling of this material contrary to label instructions.

ASP JLH 092810

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