# REGISTRATION 11678-72

# Material Sent for Data Extraction Reg. 

# #**-----f/'--L1.£.6~1f"---~;::'__"·** ::.G/=--

__ 

# Description: _____________ _ 

# D Material(s) Sent to Data Extraction Contractors: New Stamped Label Dated 

# £:d. /? olCl/I 

# , Notification Dated ____ _ 

# D New CSF(s) Dated ____ _ 

# D Other: __________ _ 

# D Decision #: ______ _ 

# D Other 

# Action/Comments:________ _
File this coversheet and attached materials in the jacket. It 

## must be well organized and clipped together, NOT STAPLED. Then give the jacket with the coversheet and materials to staff in the Information Services Center (ISC) (Room 5-4900). 

## If a jacket is full or only available as an image, please file materials in a new jacket and bring it down to the (ISC). For further information please call 703-605-0716. 

# Reviewer: 

# r&t0**~** Phone:?f?3,3(l([-**S~t?**

# r Date: 

# 4¥CI('/ Division:

# -,',;0,~d,,-,- ___ _**~,,£o sr~1:**  

## " 

# '. EPA Reg. Date ofIssuance: 

# f ft**'~**

## .~~~ Number:**~** 

### , 

# '.**~ 1-'1~** **f'RCiI~c}** U.S. ENVIRONMENTALPROTECTION AGENCY 

### 11678-72 Office ofPestieide Programs Registration Division (H7505P) Tenn ofIssuance: 

### Conditional
1200 PennsylvaniaAvenue NW Name ofPesticide Product: Washington, D.C. 20460 

### MCW Technical NOTICE OFPESTICIDE: Diflubenzuron L 

### Registration

_ Reregistration (under FIFRA, as amended)

Name and Address ofRegistran£ (include ZIPCode): 

### Ms. JenniferYentel Makhteshim Chemical Works, Ltd. c/o MakhteshimAgan ofNorth America, Inc. 4515 Falls ofNeuseRd., Suite 300 Raleigh, NC 27609
Note: Changes in labeling diffcriIlg In substancefrom that accepted in connectionwith this registration must be submiltcdto and acccpted by the Registralion Divisionpriorto use ofthelabel in commerce. In any correspondenceonthis product always refer to the aboveEPA registrationnumbcr,
On the basis ofinformation furnished by theregistrant, the above named pesticide is herebyregistered/reregistered under the Federal insecticide, Fungicide and Rodenticide Act. Reg'tstration is in no wayto beconstrued as anendorsementorrecommendation ofthis productby the Agency. In orderto protect health and the environment, the Administrator, on his motion, may at any time suspend orcancelthe registration ofa pesticide in accordance with the Act, The acceptance ofanynamein connection with theregistrntion ofa product under this Act is not tobeconstrued as giving the registrant a right to exclusive
use ofthe name or to its use ifit has beencovered byothers. 

### This product is conditionallyregistered 

### inaccordance with FlFRAsec. 3(c)(7)(A). Oncea pesticide is registered, however, it is notregarded as pennanently acceptable. Registration does not eliminatethe need for continual reassessment ofpesticides. 

### Ifthe Agency detennines that, at any time, additional data are required to maintain in effect an existingregistration, the Agency will require submission ofsuch data underFIFRA section (3)(c)(2)(B). 

### 1. Revise the EPARegistration Numberto read, EPAReg. No. "11678-72".

# :~,'~**;~~g~~v ~**  0'1<: 

## OCT 122011

# ~AoHng Pmd"" M,n'g" (I) Insecticide-Rodenticide Branch Registration Division (7504P)



### EPA Fonn 8570-6

### PageTwo 11678-72

2. Submit two copies ofyour final printed label before you release theproductfor shipment. Ifthese conditions are not complied with, the registration will be subjectto cancellation in 

### accordance with FJFRA section 6(e). Your release for shipment ofthe product constitute acceptance ofthese conditions. A stamped copy ofthe label is enclosed for your records. Ifyou have any questions regarding this notice contact Dani Daniel at 703**305~5409.** 

### Enclosure( 

# MCW TECHNICAL DIFLUBENZURON

ACTIVE INGREDIENT: % BY WT. Diflubenzuron N-[[(4-chlorophenyl)aminolcarbonyl]-2,6-difluorobenzamide

........................ 97.9% OTHER INGREDIENTS:

......................................................................................................2.1 % TOTAL: 100.0% 

### ACCEPTED 

# OCT 1 22011 KEEP OUT OF REACH OF CHILDREN 

### CAUTION Underthe Federal Insecticide. Fungiclda. and Rodenticide Act as amended for.the Manufactured for:

. .**~ ~**  M'aRhteshlm Chemical Works, Ltd. pestiCide regIStered undlllio Makhteshim Agan of North America, Inc. 

# //re 

# 11 7," 4515 Falls of Neuse Rd., Suite 300 

### EPA. Reg. No: 

## ,J'
-**~.u** Raleigh, NC 27609 EPA Reg. No. 11678·XJ(x EPA Est. No. 

### NET CONTENTS: ___ Ibs FIRST AID IFON SKIN OR • Take offcontaminated clothing. CLOTHING: • Rinse skin immediately with plenty ofwater for 15 to 20 minutes. • Call a poison control centeror doctorfor treatment advice. EMERGENCY ASSISTANCE: Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may contact Prosar at 1-877-250-9291 for emergency medical treatment information. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION: Harmful if absorbed through skin. Avoid contact with eyes, skin or clothing. Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet ENVIRONMENTAL HAZARDS Do not discharge effluent containing this product into fakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. 

### PPc not discharge effluent containing this product to sewer systems without previously notifying the**local<s~e:,'-r@ge** treatment plant authority. Forguidance contact yourState Water Board or Regional Office ofthe f-Pp,-..,


### , , DIRECTIONS FOR USE ' , , , It is a violation of Federal law to use this product in a manner inconsistent w·rth lts labctllrig:**~** , < < < Only forformulation into an insecticide growth regulator forthe following USeS: ' , : ' << :' , < (1) artichokes, barley, oats, triticale, wheat, citrus, cotton, grassland, leafy brassica ar;(3! <turr::ip greens, mushrooms, peanuts, pears, peppers, rice, soybeans, stonefruit (toJi.cluping cherrieG), treenuts, turigrass, bolus, feed-through and premise treatments for fly corlb'ul, 'non-food uses: omamentals, forestry, products for parasite control in ornamental fish ponds, wood ;0T, '«ftJpd structure protection treatments, i.e. termite bait stations; aquatic non-crop sites: e.g. proUucts for mosquito/midge control. : , , , ; , (2) uses for which U.S. EPA has accepted the required data and/or citat"lons of dataL that the formulator has submitted in support ofregistration; and (3) uses for experimental purposes thatare in compliance with U.S. EPA requirements.

### ( (

This product is fOf use only by formulators in the manufacture ofagricultural insecticide growth regulator products, offered for sale to the public, and which are duly registered with the Environmental Protection Agency, Washington D.C. Formulators using this product are responsible for obtaining EPA registration for theirformulated product(s). STORAGE AND DISPOSAL Do not contaminate water, food orfeed by storage ordisposal PESTICIDE DISPOSAL: Pesticide, spray mixture, or rinsate that cannot be used or chemically reprocessed should be disposed of in a landfill approved for pesticides. PESTICIDE STORAGE: Store the product in a dry, cool and ventilated place. CONTAINER DISPOSAL: Nonrefillable container. Do not reuse or refill this container. Offer for recycling, if available or dispose of liner in a sanitary landfill, by incineration or if allowed by State and local authorities, by buming. If burned, stay out of smoke. If drum is contaminated and cannot be reused, dispose of in a manner required for its liner. GENERAL: Consult Federal, State or Local disposal authorities for approved alternative procedures. LIMITATION OF WARRANTY AND LIABILITY Read the entire directions for use, conditions of warranties and limitations of liability before using this product. Ifterms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following CONDITIONS, DISCLAIMER OF WARRANTIES, and LIMITATIONS OF LIABILITY. CONDITIONS: The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Crop injury, ineffectiveness, or other unintended consequences may result because ofsuch factors as weather conditions, presence of other materials, or the manner of use or application, all of which are beyond the control of Makhteshim Chemical Works, Ltd. All such risks shall be assumed by the user or buyer. DISCLAIMER OF WARRANTIES: To the extent consistent with applicable law, Makhteshim Chemical Works, Ltd. makes no other warranties, express or implied, of merchantability or offrtness for a particular purpose or otherwise, that extend beyond the statements made on this label. No agent of Makhteshim Chemical Works, Ltd. is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. To the extent consistent with applicable law, Makhteshim Chemical Works, Ltd. disclaims any liability whatsoever for special, incidental or consequential damages resulting from the use or handling of this product. LIMITATIONS OF LIABILITY: To the extent consistent with applicable law, the exclusive remedy of the user or buyer for any and all losses, injuries or damages resulting from the use or handling of this product, whether in contract, warranty, tort, negligence, strict liability or otherwise, shall not exceed the purchase price paid or at Makhteshim Chemical Works, Ltd.'s election, the replacement of product. 

### Mew Diflubenzuron Technical (11678-xxx) 

### 00 EPA 09-23-11)



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### , I 

# 21-Day Screen Completed by Contractor 21-DayExpires on 10 -It-II 

# Jacket 

# # /**/~** 

# 7%

# -1£ • 

# MRID#

___ _

. 

# \ 

# Content Screen: Recommend

# to~aiI 86-5 Review:

# PasslFai~ Overall Status: Recommend

# t~ail Transfer This Jacket to:
(JfVI- / > 

# --

## PRIA 2 - 21 Day Content Screen Review Worksheet (EPNOPP Use Only) 3/23/09 

### 21 Day Screen Start Date: ___ -'9''---'2'-'-7_-

### f l-'.I ______ ___=_ Experts

## In~Processing Signature: .r7 /" **/.hA.A.M"arlW** Date 

## 9- **2';--1/** FeePaid: Yes

# Y

, 

### Division management contacted on issues No Yes Date


### EPAReg. Number: 

# IfC, 

# 7

# fr
- T EPA Receipt Date:

## ~ 

# - 27- If Items for Review Yes No N/A*


### 1

2

3



### 4

5 

### Application Form (EPA Form 8570-1)(link to form) signed & 

### complete including package type 

### Confidential Statement ofFormula all boxes completed, form signed, and to a) All inerts (link to http://www.epa.gov/opprdOOl/inerts/), including fragrances, approved for the proposed uses (see Footnote 

### Certification with Respect to Citation ofData (EPA Form 8570-34) (Link to fonn) completed and signed (N/A 

### if 100% repack) Certificate and data matrix consistent If

### applicant is relying on data that are compensable, is the offer to pay statement included. (see Footnote B) 

### yes

completed and "5'''OU 

### (N/ A if

### source is unregistered or applicant owns the no

DataMatrix (EPA Form 8570-35) (Link to fonn) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A 

### if 100%

Selective Method b) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use) 

# x

5 Copies ofLabel (link to http://www.epa,gov/oppfeadlllabelingllrmD 

### 6 (Electronic labels on CD are encouraged and guidance is available)( link to 

# Y http://www.epa.gov/pesticides/reguJatingiregistering/submissions/index.htm#labeJs / \



### 1 

# x



# x

### 7 Is the data packa2e consistent with PRNotice 86-5 (link to PRN 86-5)

### ~ Notice ofFiling (link to 8 httQ:llwww.eQa.gov/Qesticides/regulatin2/tolerance Qetitions.htm) included 

# x: with 

### petitions (link to 

### http://www.epa.gov/pesticides/regulatingltolerances.htm) 9 Ifapplicable for conventional applications, reduced risk rationale (link to 

# X http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) Required Data (link to httQ:llwww.eQa.govluesticides/regulatin2/data reguirements.htm) and/or data waivers. See Footnote C.

a) List study (or studies) not included 

### with application

< 

### 10

2

### Comments:

r.J 

### 1f)C'r--fs.
-- (00 

# % re

# pc.. C.(L, Ill>

### ~fler+.s. --b re.V!e:t-v 

### "'J DoCt{vt..

## -e

## /L+'"-f,,,,,: 

# ft:;.<>:;'



## *N/A
- 

### Not Applicable

Footnotes A. Duringthe 21 day initial contentreview, all eSFs will bereviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting it with an approved inert, submitting documentation thatEPA approved the inert for the proposed pesticidal useS, correcting mistakes on the eSF, etc. or2) providethedata to 

### support OPP approval ofthe inert or3) withdraw the application. Removing or substituting an inert ingredient will require a new eSF and mayrequire submission ofdata. All infonnation. fonns. data and docwnentationresolving the inert issuemusthave beenreceived bytheAgency orthe application withdrawn within the 21 day period. otherwise. the Agency will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even 

### ifa product is currentlyregistered by consulting the inert Web 3I 

### ( site [link to http;//www.epa.gov/opprdOOl/inertsllists.html] and 

### ifthe inert is not 

### approved, to obtain the necessaryinert approval priorto submitting an application to register a pesticide product containingthat inertingredient. Some inert ingredients are no longer approved for food uses or certain types ofuses. The name andlor CAS number on a CSF must matchthename and 

### CAS number on this web site. Simpletypographical errors in the name or CAS numberhave resulted inprocessing delays. 

### Ifan inert is not listed on the inert ingredient web site and the applicantbelieves thatthe inerthas been approved, the applicant should contact the Inert IngredientAssessment Branch (IIAB) at inertshranch@epa.gov andresolve the issue. Copies ofthe correspondence with lIAB resolving the issue should accompanythe application. All new inerts exceptPIP inerts arereviewed by IIAB. The lIAB should also be contacted for any questions on what supporting data needs to be submitted for and the Agency's inert review process. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Link to http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm]. When a brand, trade, orproprietary name ofan inert ingredient is listed on a CSF, additional information suchas an alternate name ofthe inert, CAS number or other information [link tohttp://www.epa.gov/opprdOOllinerts/tips.pdt] mustalso be included to enable the Agencyto determine ifit has beenapproved. Each component ofan inert mixture (including a fragrance) mustbe identified. 

### In some cases, the supplier ofthe mixture orfragrance mayneed to providethis information to the Agency. Prior to the Agency's receipt of an application, applicants must arrange with a proprietary mixture or fragrance supplierto provide the component informationto the Agency or promptlyupon EPA's request. Ifthe inert ingredients in a proprietaryblend (including fragrances) cannot or are not identified orprovided within the 21-day contentreview period, the Agencywill rejectthe application. During the 21 day content review, applicants should submit information to the individual identifiedby the Agency whenthe applicant is informed ofan unapproved inert. Unapproved Inerts Identified on CSFs All applications except conventional new products and PIPs Once an unapproved inert is identified on a CSF, the Agency will contactthe applicant with the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentationthat the inert has been approved, or removing the unapproved inertfrom the CSF orreplacing it with onethat is approved for the application's uses; or 2. Submit the information and data needed for theAgency to approvethe unapproved inert. 

### Ifthis option is selected and implemented, the Agency may request an extension 

### in the PRIA decisionreview timeframe to accommodate the inertreview/approval process; 

### 43. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implemented by the applicant within the 21 day contentreview period, theAgency will reject the application and retain 25% ofthefull fee ofthe category identified. Conventional New Product Applications When the Registration Division identifies an unapproved inert on a CSF with an applicationfor a newproduct that the applicant has not identified as requiring an inert approval (R311, R312 orR313), it will contact the applicant with the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inertfrom the CSForreplacing it with one that is approved for the application's uses;:-or 2. Submit the infonnation and data needed for the Agencyto approve the unapproved inert, including anyrequired petition to establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which couldrequire a longer decisionreview time and a largerfee. 

### Ifadditional fees are due, theymust be received by the Agencywithin the 21 day contentreview period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or
Ifnone ofthe above options is selected and implemented during the 21-day content-review period, the Agency will reject the application and retain 25% of the appropriatefee for the newproduct-inert approval category. PIP Applications When the Biopesticide and PollutionPrevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inert does not accompany the application, it will contact the applicant with the following options: 1. Correct the application by, for instance, correctingthe spelling orname ofthe inert to that in40 CPR 174, or providing documentation that the inerthas been approved; or 2. Submitthe infonnation and data needed for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemptionpetition is required, thepetition must bereceived by the Agency and the B903 fee paid withinthe 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 

### 5

### 3. Withdraw the application (the Agencyretains 25% ofthe full fee forthe fee category estimated); or If

### none ofthe above options is selected and implemented during the 21 day content review period, the Agency will reject the application and retain 25% of the fee.
B, A policy on documentation ofoffers to payis still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or

### A530, an application without the necessary authorizations ofoffers to pay will beplaced into eitherR30 1or 

### A53!. The Agency recommends that authorizations ofoffers to paybe submitted with otherPRIA applications to avoid delays in theAgency's decision. C. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submitting their application to the Agency, Documentation ofsuch discussions should be submitted with the study waiver.

6( ( UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### September 28, 2011

OPPDecisionNumber: D-455479 EPA File Symbol orRegistration Number: 11678-TE ProductName: MCWDIFLUBENZURON TECHNICAL EPA Receipt Date: 27-Sep-2011 EPA Company Number: 11678 Company Name: MAKHTESIDM CHEMICAL WORKS LTD CHUCKLEVEY MAKHTESIM-AGAN OF NORTH AMERlCA, INC. MAKHTESIDM CHEMICAL WORKS LTD 4515 FALLS OF NEUSERD, SUlTE 300 RALEIGH, NC 27609- OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration 

### Application Subject to Registration Service Fee Dear Registrant: The Office ofPesticide Programs has received your application and certification of payment. Ifyou 

### submitted data 

### with this application, the results ofthe 

### PRN-86-5 screen 

### will be communicated separately. During the administrative screen, the Office ofPesticide 

### Programs has determined that this Action is subject to aPesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. The Action has been identified as Action Code: R300 NEWPRODUCT;ME-TOO PRODUCTFASTTRACK; 

### No additional payment is due at this time. If

### you have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362. 

### Sincerely.

## ~:::::z.L Front End Processing Staff Information Technology & 

### Resources Management Division

# IFee for Servicel

This package includes the following for Division

Cil 

# New Registration °AD °Amendment °BPPD Cil 

# RD o 

# Studies? o 

# Fee Waiver?
o 

# volpay 

# % Reduction: Risk Mgr. Receipt No. 

# s-I 904050 EPA File Symbol/Reg. No. 

# I 11678-TE Pin-Punch Date: 

# I 9/27/2011 

# o This item is NOT subject to FFS action. 

# i(904050i

# IT] 

# I I I

. ParenVChild Decisions:


# . Requested: 

# 1'4-3 Ob 

# I Granted: 

# I 

# e-> (Ji) 

# I Amount Due: 

## $ ;L{3({Ob


# to Intended Use D 

## Uncleared Inert in Product Date: 

# 7 

# k //;(

, 

## Reviewer:._--II-l.L'.--'d,L-"""'-'---"'--- ___ _ Remarks:( 

## R300 and 301
100% identical [repack):!ffi'or NO [circle onel

{Ifyes, it's a 100% repach""n product chemistry, acute toxicity and efficacy data

are not required} Data on Group and A and Bmust be submitted - Group A and Bcan not be cited. 

### Data Guideline 

### Group A: Product Chemistry Data submitted No. StudyTitle Yes No 830.1550 Product Identity & 

### Composition Description of materials used to produce the 

### 830.1600 product 830.1650 Description of formulation process 

### 830.1670 Discussion on the formation of impurities 

### 830.1700 

### preliminarv analvsis 830.1750 Certified limits [158.3451 830.1800 Enforcement analytical method
Data Guideline Group B: Product Chemistry Data submitted 

### No. StudyTitle Yes No 830.6302 Color 

### B30.6303 Physical state 830.6304 Odor Oxidation/Reduction 

### [Chemical 830.6314 incompatibility) 830.6315 Flammability 830.6316 Explodability 830.6317 storage stability 830.6319 Miscibility 830.6320 Corrosion Characteristics 

### B30.6321 Dielectric Breakdown YoltaQe 830.7000 pH 830.7100 Viscosity 830.7300 Density 

### 1

### ( 

### R300 and 301 

## , 

# ,

New products must provide a bridging rationale document. The bridging document directs OPP to use a currently registered set of 6 acute toxicity data and label; instead of submitting product specific data.

Guideline 

### Acute toxicity (6 pack) Cited No. studyTitle Yes No 870.1100 Acute Oral (LD50) 870.1200 Acute Dermal ILD501 870.1300 Acute Inhalation (LC50) 870.2400 Acute Eye Irritation 870.2500 Acute Dermal Irritation 

### 870.2600 Dermal Sensitization

Efficacy - which guideline depends on the proposed label use and they must cite the 

### data to be used for the bridging rationale.

Guideline 

### Cited No. Efficacy Study Titles Yes No Comments 

### 810.3100 Soil Treatments for Imported Fire Ants Livestock, Poultry, Fur and Wool-8earing 

### 810.3200 Animal Treatments Treatments to Control Pests of HUmans 

### and 810.3300 Pets Mosquito, Black fly, and Biting Midge 810.3400 (Sand fly) Treatments 810.3500 Premises Treatments 

### 810.3600 structural Treatments 

### Methods for EfficacyTesting of Termite 810.3800 Baits



### 2Regulatory Type:**lpro~_uct ,Re~i~ratiOfl** **~ Se~on**  3

### _=~l fee for ,Service:**'C-~-',-~"~** '. ----'--"''' Application Type:**l.~e~. R,:~str.atl~.**  .; 

## '=;J,' ,BHiable: CompanY:

### ~}~:~~w 'i)ll1/l,KHTESHIM

### CH~ICA~**W<?RK~,L**TD

,_ ,,·r.·._., _._,, __ .'_ ,_",. "_ "'."._ Risk Manager:**I~e~~~~~on ~iv~si~,**  R,is,k_**¥~n~ge~ent, Te'~~_** **~,,;,** _''r 

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### ~ale: 

### 123

-sep-2011 

# i!dI

front Eljd'

### Date:: '-127**~S~p_2011** - 

# !.WI " fF-O OUe

### Date:**L~-** 

# ,-,- 'oppTarget Date: 

# r-" CpP Rec'vd Date: ]27-sep-2011_**~I** Risk Manager Send Date: 

# 1 'l!2Il NegoI:latedDueDate'.

### rl~~~~
" F'i5tJre.ck; 

## r

Receipt"DescriPtion: New Ingrelilent. 

## r" View/Edit

o register a 100% repackage of a registered technical product NeVi Jngrefil<:'fll 

## l r**~----,** F."e-quiSd Dale:

.. ', IJ2W Ingredient "I**~-~-­** Received Oale-' SiDn:;IUI''; DblE: 

# I

.., ..**.~~I**

### JenniferYentel From: 

### Sent: To: Subject: 

### (

paygovadmin@maiLdoc.twai.gov Monday, September 19, 2011 10:46AM JenniferYentet Pay.Gov Payment Confirmation 

### THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY. Your transaction has been successfully completed. Transaction Summary Application Name: PRIA Service Fees Pay.gov Tracking ID: 254FHGHS Agency Tracking 1D: 74238706238 (



### Name On Account: Makhteshim Agan of North America Transaction Type: ACH Debit Transaction Amount: $l,434.0e 

### Payment Date: Sep 2a, 2811 Account Type: Business Checking Routing Number: Account Number: ************7618 Transaction Date: Sep 19, 2811 18:45:38 AM Number of Payments Scheduled: 1 

### Frequency: OneTime Decision Number: Registration Number: 11678- Company Name: Makhteshim Chemical Works Company Number: 11678 Action Code: R300

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## ~ Registration OPP Identifier Number 

# &EPA Environmental Protection Agency Amendment Woshington, DC 20460 

### Other Application for Pesticide
- Section I I.**companV(Prod~e** Number 2. EPA Product Manager 3. Proposed Classification

11678·XXX 

## 1 Kable Bo Davis l!jNone 

# o Restricted 4. CompanvlProduct (Name! PM. MeW Diflubenzuron Technical 25 5. Nama and Address of Applicant (Iflcludll ZIP CodllJ 6. Expedited Reveiw. In accordance with F!FRA Section 3{c)(3)

Makhleshim Chemical Works, Ud. (blli), 

### mv product is similar or identical in composition and labeling clo Makhteshim Agan ofNorth America, Inc. to: 4515 Falls ofNeuse Rd., Suite 300 EPA Reg. No. RaleiQh. NC 27609 

# o Chllck ifrhis is I!I fllIWsddrlltiS Product Nam 

### Section

- II 

# 0 Amandment

- Explllin below. 

# U Final printed laba!s in rapsonso to Agencv lettar dotad 

# 0 Resubmission in rasponsa to Agencv letter dated 

# [2] "M9 Too· Appftcation. 

# 0 Notificalion

- Explain below. 

# 0 Othar

- Explllin below. • Explanation: Uso edditionlll pagels) if necessary. (For section rand Saction II.! Application to registera 100% repackage ofa regislered technical product. Fee Category: R300 Fee Due: $1 ,434 The PRIA fee has been paid on-line at www.pay.gov. A copy ofthe electronicconfirmation is attached. E-mail: jyentel@manainc.com 

### Section

- III 1. Materiel Thi_ Product Will Sa Packeged In: Child·Resistanl Packaging Unit Pockllging Wator Soluble Pockaging 2. Typo of Container 

# tZlv " @v., 

# B V"

# ~M"" .f N. 

### .f N. of Pfastic N. Gloss • Certification must If ·Yas· No. per !f "Yes" No. per PaplIl Unit Packaging wgt. container Peckage wgt container Other (Specify! bs submftttHI I 3. location of Net Centants Infolmation 4. Siza(s) Retail Containllr 5. location of lobal Oirections



### [{J labal 

# U Container 55 Ib

- bulk 

## t::::=::j On lobel On labeling accomponylngpteduci 

# 0 ' , < ( 6. Manner in Which label is Affixed to Product 

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# ..**-~** 

### Section

- IV " '(, ,


### , " 1. Contact Point (Comp/ore ifllms dirllclly below forid(Jfltificatiofl ofifldividueJ fo be contllcflld, ifflIICD$Sary, ro pcoctnS fhis ElPP/iollriq'l.(**~-,** Name Title 

# 'I Tofopi;one Nd. On'clude Ailla Coda) Jennifer Yentel Regulatory Specialist , «9:1:9) 

### 256-93105 : 

# .. Certification " , " 6. Oot(. Applicatien r cenifV that the stotllments! hove made on this form lind ell attachments theleto are true, accurate and complate. ,Recei·Jed
, • <, , I acknowledge thet any knowlingllv folso or misleading statement mav be punishable bv fino orimprisoNnent or (Stamped) both under applicllb!e law. , ", 

# .. , 2. Signature 3, Title

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# r'&L Regulatory Specialist 4. Typed Nama 5. Doto JenniferYentel 09·23·2011

.. EPA Form 8570·' (Rev. 3-94) PreVIous adltlons lire obsolete. White

- EPA fik, Copy (origin.'j YeDow • App&cant Copy

# [t]

MANA September23, 2011 Document Processing Desk {REGFEE} Office of Pesticide Programs (7504P) u.s. Environmental Protection Agency Room 5-4900, One PotomacYard 2777 S. Crystal Drive Arlington, VA 22202-4501 

### (

Attention: Phone: Kable Bo Davis, Registration Division, Herbicides Branch (PM Team 25) 703-306-0415 RE: Application to Register a Currently Registered Active Ingredient
- 100% Repack Mew Diflubenzuron Technical (EPA File Symbol 11678-xxx) PRIA Category R300; $1,434; 3-month review Dear Mr. Davis, On behalfof Makhteshim Chemical Works, ltd., please find the enclosed application materials forthe registration of MeW Diflubenzuron Technical. a manufacturing use product containing diflubenzuron as the active ingredient. In support ofthis application, we submit the following documents: 1. Application for a New Pesticide Registration (EPA Form 8570-1) 2. Receipt of PRIA pre-payment from pay.gov 3. Confidential Statement of Formula {EPA Form 8S70-4} (2 copies) 4. Formulator's Exemption Statement (EPA Form 8570-27) 5. Five {5} copies ofthe draft labeling 6. This newapplication for registration is for a 100% repackage ofa registered technical active. This application falls under Category R30Q {44: New product}. As a 100% repack registration, it requires "'- '- 

### , neither data submission nor data matrix. The fee, which has been paid, is $1,434 and the**decisi60,titT1~** line is 3 months. ' , , 

### , ,

,,' , Ifyou have any questions or concerns regarding this applicaflonfor registration, pleose:;::'o:ltact me 'at c , , , , your convenience at jyentel@manainc.com or {919} 256-9315. , , , , , ,**~'** , , ' Sincerely, 

# 91'"1+**~ot",,\uL** Jennifer Yentel Regulatory Specialist Enclosures 4515 Falls ofNeuse Road, Suite 300, Raleigh 

### Ne 27609 T: 919.256.9305 • F: 919.256.9308 

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### ( ( Form approved. OMS No. 2070-0060, 2070-0l>¥. , 2070-0107, 2070-0122, 2070-0164. 

# &EPA United States Environmental Protection Agency Washington, DC 20460 Formulator's Exemption Statement (40 CFR 152.85)
Appl'lC<lnfs Name and Address EPA File SymbOURegistralion Number Makhteshim Chemical Works Ltd. 11678-xxx c/o Makhteshim Agan ofNorth America, Inc. Product Name 4515 Falls ofNeuseRd., Suite 300 MeW Diflubenzuron Technical I] Raleigh, NC 27609 Dale of Confidential Statement of Formula (EPA Form 8570-4) 09/23/2011 As an authorized representative ofthe applicant for registration at the product identified above, I certify that: (1) This product contains the following active ingredient(s): Diflubenzuron (Dimilin)

(2) 01 these, each active ingredient listed in paragraph (4) is present solety as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging another productwhjch contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another person and meets the requirements of40 CFR section 158.50(e}(2) or (3). (3) tndicate by checking (A) or (8) belowwhich paragraph applies:
71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source ofthe active ingredient(s) listed in paragraph (t). OR



## ..., (8) The Confidentiat Statement of Formuta (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, an accurate and contains the information required on the current CSF. (4) The following active ingredients inthis product qualify for the formulator's exemption.

Source Active Ingredient Product Name '" Registrati(n Numller < ( < , Diflubenzuron

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### , , . Signature Name and Title Jennifer Vente) Date 

### G'L""-\r'-- Vjt1L\-bL 09/23/2011 ' , " 

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### . Regulatory Specialist I] EPA Form 8570-27 (Rev. 06-2004) Copy 1 EPA Copy 2 - Applicant copy

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