# REGISTRATION 74054-5 Part 3

# Material to be added to an e-JackeUJacket Reg. No. 

# 1tpJ5tf,..t;;
Description

# :_--'-'fl"'-':s,"---"-t_D_I-I-""-QlL.!A--"--t--=C¥F=--=--'---
______ _ t 

# 1. 0 

# Placementwithin the e-Jacket/jacket: 

# d Default: (chronological, top:::: newest) o 

# File location: (PDF page number, i.e., "before page 45")

2. /sendto))9ta Extraction contractorsthis material:

# ~ Newlystamped accepted label o /' Notification -g/ 

# New CSF I

# al:r~-r.>**~** o Other:
3. Attach this coversheetto the top oUhe material orjacket. It must be well organized and clipped together, NOT STAPLED. Then give the materialwith this coversheetto staffinthe Information Services Center(Room 5-4900). 

# Reviewer's Name:

# 6·A·~ Phone:**7·bo~ o6f~**  

# Division:

# --=eb=-
__ _ Date:

# ~±~/_~_l!r~--I_I--

# ______________---

Created August21, 2008

_, _" _.

,__ 0_. 

# _,_._ru,_.**~** 

# ___**~_.** 

# _._____ _

### Please Return Jacket to File Room for Data Extraction OPPIN Data Entry to: burgess.shirley Sent by: DCOPPAPPS01 Cc: akinlosotu.bonaventure, Jackets-For-Coding 04/21/201111:31 AM

SUBJECT: Please Return Jacketto File Room for Data Extraction for Registration: 74054-5, Decision: 442729 An action wasjustcompleted for Registration (74054-5), Decision (442729) that may require data extraction and 

### I or imaging ofa label for inclusion in the Pesticide Product Label System. Please return jacket (9283474) to the file room, and check it outto ISB"s data management contractor as soon as possible. 

### Ifyou have already returned thisjacket, please accept ourThank you. This is an automatically generated notification message. Please do not reply to this address.

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### April 21, 2011

Irvital PlantProtectionN.V. % 

### AnnM. Tillman, Consultant Pyxis Regulatory Consulting, Inc. 4110 136'h St. NW GigHarbor, W A 98332
Subject: Amendment

- Add alternate CSF, and outdooruses MCW437 Technical (EPAReg. No. 74054-5) Application datedNovember 29, 2010
DearMs. Tillman: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### The abovereferenced submission, inconnectionwithregistrationunderthe Federal Insecticide, Fungicide, and RodenticideAct (FIFRA), as amended, is acceptable.
Please notethat we have approvedthe amended Confidential StatementofFormula (CSF) and labeling for the subjectproductwiththeunderstandingthatthey are consistent withthe Agency's previously accepted CSF andlabels, and that no other changes have beenmade. Wehave included copy ofthe newly accepted alternate CSF dated 02/03/11 

### inthe record for the subjectproduct.
See enclosedcopy ofthe stamped label for yourrecord. Ifyouhave any questions concerningthis actionpleasecontactDr. B.A. Akinlosotuat (703) 605-0653. Sincerely,

ichard Gebken, ProductManager 10 Insecticide Branch RegistrationDivision (7505P)

Enclosure' Stamped acceptedlabelACTIVE INGREDIENT: 

## MCW437 TECHNICAL For Manufacturing Use Only
FiproniI: 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyIJ-4-4-[(1

### R,S)-(trifluoromethyl)Sulfinyl)J1H-pyrazole-3-carbonitrile

.........................................................................................96.5% OTHER INGREDIENTS:

.............................................................................................3.5% TOTAL

........................................................................................................................100%
EPA Reg. No 74054-5 

# KEEP OUT OF REACH OF CHILDREN WARNING/AVISO

FIRST AID EPA Est. No:

If 0 Call a poison control center ordoctor immediately fortreatment advice. swallowed: 0 Have person sip a glass ofwater ifable to swallow.

0 Do not induce vomiting unless told to do so by the poison control center or doctor.

0 Do not Qive anythinQ by mouth to an unconscious person. If inhaled: 0 Move person to fresh air.

0 If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth ifpossible.

0 Call a poison control center or doctorfor further treatment advice. Ifin eyes: 0 Hold eye open and rinse slowly and gently with waterfor 15-20 minutes.

0 Remove contact lenses. if present, after the first 5 minutes. then continue rinsing eye.
0 Call a poison control center or doctorfor treatment advice. Ifon skin or 0 Take offcontaminated clothing. clothing: 0 Rinse skin immediately with plenty ofwaterfor 15-20 minutes.

0 Call a poison control center or doctorfor treatment advice. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor. or going for treatment. You may also contact 1-800-308-5391 for emergency medical treatment information. NOTE TO PHYSICIAN There is no specific antidote. All treatment should be based on observed signs and symptoms of distress in the patient. Overexposure to materials other than this product may have occurred. 

### 'r severe cases of overexposure by oral ingestion, lethargy. muscle tremors, and in extreme cases'l possible convulsions. may occur. Manufactured for: Irvita Plant Protection. NV 

# APR 2 1

# 2011 clo Makhteshim Agan of North America. Inc.



## ACCEPTED 

## Underthe Federal Insecticide Fungicide, 4515 Falls of Neuse Road, Suite 300 

## , h Raleigh NC 27609 

# andRodenticideAct, asamended,fort e ' pesticide registered under: Net Weight: XXXX lb. 

# EPA. Reg. No: 

# 7Jf.o5JI-..-5

MCW437 Technical label

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS WARNING. May be fatal if swallowed or inhaled. Harmful if absorbed through skin. Causes skin irritation and moderate eye irritation. Avoid contact with skin, eyes or clothing. Do not breathe dust. Wear goggles, face shield or safety glasses. Wear protective clothing and rubber gloves. Wear a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21 C), 

### or a NIOSH approved respirator with any N, R, P or HE filter. Wash thoroughly with soap and water after handling and before eating, drinking chewing gum or using tobacco. Remove and wash contaminated clothing before reuse.


### ENVIRONMENTAL HAZARDS Do not discharge effiuent containing this product into lakes, streams, ponds, estuaries, ocean or otherwaters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting of authority has been notified in writing prior to discharge. Do not discharge effiuent containing this product in sewer systems without previously notifying the sewage treatment plant authority. For guidance contact your State Water Board of Regional Office ofthe EPA. 

### DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. For manufacturing use only into insecticide products for the following uses*:

• Residential indoor: (companion ani mals, crack and crevice baits and bait stations) • Indoor non-food: (commercial, industrial, and institutional facilities, modes of 

# C.o transportation), crack and crevice baits, and bait stations

/1

## ~miticides: (pre and post construction soil application) • Terrestrial non-food: (golf courses, sod farms, commercial lawns, and perimeter treatment around commercial buildings) 

# ("0/ Residential outdoor: (lawns, perimetertreatment around buildi ngs &**~** 

### ornamentals) This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U. S. EPA data submission requirements regarding the support of such use(s). Each formulator is responsible for obtaining EPA registration for their end-use product(s).
*This product is not for formulation into end-use product for use in or on food/feed areas, including food handling establishments (except for crack and crevice and bait station products) or in/orfood/feed.



## Mew437 Technical label 2

### STORAGE AND DISPOSAL Do not contaminate water, food, orfeed by storage, disposal, or cleaning or equipm en!. Pesticide Storage: Store in original container, Store in a cool, dry place, Pesticide Disposal: Wastes resulting from the use ofthis product may be disposed of on site or at an approved waste disposal facility, Container Disposal: Nonrefillable container. Do not reuse or refill this container. Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles, Empty residue into processing equi pmen!. Then dispose of liner in a sanitary landfill or by incineration ifallowed by state and local authorities, Offerthe drum for recycling, ifavailable,
FOR 24·HOUR EMERGENCY ASSISTANCE (SPILL, LEAK, OR FIRE), CALL INFOTRAC AT 

### 1·800·535·5053, LIMITATION OF WARRANTY AND LIABILITY Read the entire directions for use, conditions ofwarranties 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, Crop injury, ineffectiveness, or other unintended consequences may result because of such factors as weather conditions, presence ofother materials, or the manner ofuse or application, all of which are beyond the control of Irvita Plant Protection, NV, However, it is impossible to eliminate all risks associated with the use of this product. All such risks shall be assumed by the user or buyer. DISCLAIMER OF WARRANTIES: To the extent consistent with applicable law, Irvita Plant Protection, NY makes no otherwarranties, express or implied, of merchantability or offitness for a particular purpose or otherwise, that extend beyond the statements made on this label. No agent of Irvita Plant Protection, NY is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein, To the extent consistent with applicable law, Irvita Plant Protection, NY disclaims any liability whatsoever for special, incidental orconsequential damages resulting from the use or handling ofthis product, LIMITATIONS OF LIABILITY: To the extent consistentwith applicable law, the exclusive remedy ofthe user or buyer for any and all losses, injuries or damages resulting from the use or handling ofthis product, whether in contract, warranty, tort, negligence, strict liability or otherwise, shall not exceed the purchase price paid or at Irvita Plant Protection, NV,'s election, the replacement of product.

MCW437 Technical label 

### 3

### DP BARCODE No.: 386395 FILE SYMBOL No.: 74054-5 DECISION No.: 442729 PC Codes: 129121 ACTION CODE: R340 NON-FOOD Use:



### Date: 12 April 2011 SUBJECT: Product Chemistry Review ofthe Manufacturing Use Product, MCW437 Technical FROM:

TO: Bruce F. Kitchens, Chemist Technical Review Branch/RD (7505P) Registration Division (7505P) RM #10, Richard Gebken/BonaventureAkinlosotu Insecticide Branch Registration Division (7505P) DP BARCODE: 0386395 DECISION No.: 445729 File Symbol No.: 74054-5 PRODUCT: TGAI PCC: 129121 REGISTRANT: Irvita Plant Protection NY USE: Manufacturing Use Product INTRODUCTION: The registrant, Irvita Plant Protection NY, is submitting an application for an alternate formulation (alt.#1) forthe registered manufacturing use product, MCW437 Technical. This alternate formula is the result of the use ofan alternate production site. The active ingredient in this product is Fipronil at a label nominal concentration of 96.5% a.1. This product is intended for use in the manufacture of insecticide end-use products. In 

### support ofthis request, the registrant has submitted an alternate Confidential Statement of Formula (CSF) dated 03 Feb 2011 and product chemistry data contained in MRID#s 483108-01,-02,- 03,04,-05,-06,-07,-08,-09,-10,-11. The Technical Review Branch (TRB) has been asked to review this submission. SUMMARY OF FINDINGS: TRB has reviewed this submission and reports the following findings: 1. This product is produced from an integrated formulation system. This means that the product is the result of intended chemical reactions. 2. All impurities have been assayed and identified by the registrant. The registrant has not declared any impurities oftoxicological concern in this product. All impurities have a nominal concentration and an upper certified limit. 3. The nominal concentrations ofthe active ingredient listed on the proposed alternate CSF and the current basic CSF (dated 17 Mar 2009) are the same. 4. The active ingredient's certified limits as proposed on the alternate CSF are acceptable.

### DP BARCODE No.: 386395 FILE SYMBOL No.: 74054-5 DECISION No.: 442729 PC Codes: 129121 ACTION CODE: R340 NON-FOOD Use:



### 5. See the confidential appendix for results ofthe preliminary analysis. 6. The alternate manufacturing site is listed below. Representative batches of MCW437 Technical were manufactured and analyzed at this site.



# J CONCLUSIONS: TRB 

### has reviewed this submission and concludes the following: 1. The proposed alternate formula CSF for the manufacturing use product, MCW 437 Technical dated 03 Feb 2011 is acceptable. 2. This submission satisfies the data requirements as specified in 40 CFR 158.155, 158.160, 158.162, 158.167, 158.175, and 158.180 with respect to product identity and composition, description of materials used to produce the product, description of production process, discussion offormation of impurities, certified limits, and enforcement analytical method. 3. The registrant requested waivers for physical and chemical properties data in MRID# 4831 08-05. Physical and chemical properties data are not required for an alternate technical formula produced at an alternate production site, only the Group A data are required. 4. This submission meets the criteria specified in 40 CFR 152.43 with respect to alternate formulations.

2

### DP BARCODE No.: 386395 PC Codes: 129121 NON-FOOD Use: FILE SYMBOL No.: 74054-5 ACTION CODE: R340



# ITable 1.**Manufacturin~** and Impuritz: Data for MeW437 Technical 

### DECISION No.: 442729



# IGLN 

# II Reguirement 

# II MRID 

# II Status 

# II Details andlor Deficiency 830.1550 The NC ofAI (96.5%) is supported by 5 batch Product Identity and composition 483108·01 A analysis & agrees with the label claim NC. impurities {> 0.1%)are listed on the CSF The product specification sheets {MSDS} for all 8301600 Description of materials used to 483108·01 A the starting materials have been provided by produce the product the registrant The AI was produced
830.1620 Description of production 483108·01 A process The production process has been described in full detail. The reaction conditions, amounts of chemicals in each step, duration oftime, and the yields in each step have been provided. The OA steps involved in each step have been described. The registrant has provided the complete mechanisms offormation, quantification and 830.1670 Discussion offormation of 483108-01 A identification ofall the impurities present at the impurities levels of**~** 0.1 %. Total of impurities have been lis1ed on the CSF in addition to water and uniden1ified impurities. The registrant has provided 5 batch analysis for the TGAI. TheAI & impurities were identified 830.1700 Preliminary analysis 483108·02 A and quantified by using reversed phase 483108-03 HPLC/UV internal standard method. The 483108-04 methods were validated for specificity and linearity. The LOO for the AI & each impurity have been determined. The fwe batch analysis supported the CSF forthe proposed alternate formulation. The proposed certified limits for1he AI & for the 830.1750 Certified limits see csf A impurities are based on the five batch analytical

..... . _."

.. 

### ?n/ 1

...1

... ........ .............................. results.

......................... .......... 

## ....fils·

..rever's·ed"

..p·il·a·se·

..reve·rs·e

..p'ha·se"-Hi5LC7Dv.-. 830.1800 Enforcement analytical method 483108-01 A method was used forthe determination ofthe AI conieni in Ihe TGAI/MUP. A

## = Acceptable; N

## =unacceptable (see Deficiency); N/A

## = NotApplicable; G = Data gap; I = In progress or need upgrade; U =**Up~Qrade** (additional information required 

# I I

-

3

### DP BARCODE No.: 386395 FILE SYMBOL No.: 74054-5 DECISION No.: 442729 PC Codes: 129121 ACTION CODE: R340 NON-FOOD Use:

CONFIDENTIAL APPENDIX
Results ofthe 5 batch analysis are provided in the following table:

Table 1: Five batch analysis summary results Analyst Lab Active ingredient Total 1mpurities Overall batch Batch 

### No. accountability Number (% w/w) (% w/w) (% w/w) 10-08754 427-063-01 96.0 3.26 99.3 10-08755 427-083-02 96.5 2.96 99.4 10-08756 427-063-03 96.4 2.77 99.2 10-08757 427-063-04 96.6 3.14 99.7 10-08758 427 -Ofl3-0S 96.6 2.88 99.5 Average 96.4 3.00 99.4



### The determined content of 

### MeW 437 was between 96.0 to 96.6% w/w (mean 96.4% w/w). The total impurity content ranges between 2.77 to 3.26% (mean 3.00% w/w). The overall accountability ofthe batches ranges between 99.2 to 99.7 %w/w (mean 99.4% w/w).

1

### Technical MCW 437. 

### Determination ofActive Ingredient and Impurities Present at or above 0.1% 

### by HPLC. Analyst SOP 09.308.02.

4c c 

## «

C') o -" <D LLFeb 03 11 03:02p Ann 6104585431 p.3

### UNITED STATESENVIRONMENTALPROTECTIONAGENCY WASHINGTON,D.C. 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION



### Date: March 10,2011 Chemical: Fipronil PC Code: 129121

## /.?-~,/ DP Barcodes: DP 386404**and:E~?696_)~_** 

### / DpC-l"J'ON: 

## "/4%Q5 And 

## (442'72-1 ') 

# , MEMORANDUM

SUBJECT:

FROM:

TO: 

# If.,)
R ' fd '

. f' f 

## I"

. hn' 

## I

eVlew 0 

### atamatnx III 

### support 0 

### revJ,ew 0 

### a p IcatIg}1 to register newtec Ica product, me-too labeling (EPA 74054-/11 

# f 7 o5t\:..

. 

# k:**~** 

# \:

.**0~~ C-h,~** 

# /'/-r1'<) Nancy Andrews, Branch Chief }--

# \c'-.- 11

# ~C**~**

# / /o/! / Edward Odenkirchen, Senior Science

# Ad".~y{)v

. /' 

# I: StephenWente, Biologist

## 5C;P/"7~~:? 101/;' Environmental Risk Branch I Environmental Fate and Effects Division (7507P) Office ofPesticide Programs Richard Gebkin, Risk Manager Bonaventure Akinlosotu, Risk Manager Reviewer Registration Division Office ofPesticide Programs (7505P)

The Environmental Fate and Effects Division (EFED) was requestedbythe Registration Divisionto review a data matrixprovidedby IrvitaPlant Inc. in support ofits requestto add residential outdooruses (lawns, perimetertreatInents aroundbuildings, and ornamentalplants) to Irvita's "metoo" registration ofMCW437 Technical containing 96.50% fipronil. EFED cannot commentonthe legal aspects ofwhatis oris notcompensable. However, EFED did identifythe specific studies considerednecessary (Section4 ofDP 377687, 379158) and unnecessary (Section 5 ofDP 377687, 379158) for EFED to conduct an ecological risk assessment on Irvita's requested fipronil registration. The addition ofthe residential outdooruses does notchange EFED's data requirements. Please see DP 377687, 379158 for the necessary infonnation.

I

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION



### MEMORANDUM
Date: March9, 2011 SUBJECT: Fipronil: Review ofdata matrix in support ofreview ofapplication to register new source teclmical product and add outdooruse to teclmicallabel

/' 

### DP Barcode: 386695 Registration 

### N().: 74054-

# 5" PC Code:

# l291~~/ Decision No.: (142729 Petition No.:

## ~ Regulatory Action: ProductRegistrationSection 3 RiskAssessmentType: NA TXRNo.:NA CaseNo.: NA CAS No.: NA MRIDNo.: NA

FROM:

TO: 40 CFR:NA

Jack Arthur, Chief

# d~**~** Risk Assessment

# BZ~" ,f 

### HealthEffects Division (7509 P)

Richard Gebken, RiskManager Bonaventure Akinlosotu, Risk Manager Reviewer Insecticide Branch RegistrationDivision (7505P) vcr.Apr. 2010



### The HealthEffects Division (HED) was requested by the Registration Divisionto review a data matrix provided by IrvirtaPlantInc. in support ofits request for aregistration ofMCW437 Technical containing 96.50% fipronil and beingproduced by a new source. The registrant, Irvita PlantProtectionN.V., also indicated that the technical label has beenrevised to add outdoor uses. HED reviewed the healtheffects and human exposure study components ofthe data matrix submitted for registration ofMCW437 technical grade fipronil from theprevious source. The data matrix and teclmicallabel (including outdoor uses on lawns, perimetertreatment and ornamentals) for the new source ofMCW437 is essentiallythe same as submitted in its previous submission. Therefore, the conclusions reached by HED in its datamatrix review for the previous submission apply to this submission as well. Ifoutdooruse is a new additionto the

Page I of2

### label, this would not alter the conclusions reachedbyHED withregard to the data matrix. Outdoorresidential uses require the same array ofstudies as the indooruses that have continued to be listed onthe technical label.

Page 2 of2UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### December 6, 2010

MAKHTESHIM-AGANOFNORTH AMERICA INC IRVITAPLANT PROTECTIONN.V, 4515 FALLS OFNEUSE RD STE 300 RALEIGH, NC 27609-

Report ofAnalysis for Compliance with PR Notice 86-5 OFFICEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of02-DEC-1O, Our staffhas completed apreliminary analysis oftbe material. Theresults are provided as follows:
Your submittal was found to be infull compliancewitb the standards for submissionof data contained inPRNotice 86-5, A copy ofyourbibliography is enclosed, annotated witb MasterRecord ID's (MRIDs) assigned to each document submitted. Pleaseuse tbese numbers in all future references to tbese documents, Thank you for your cooperation. Ifyou have any questions concerningtbis data submission, pleaseraise tbemwiththe cognizantProduct Manager, to whomthe datahavebeenreleased,UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### December 3, 2010

OPP DecisionNumber: D-442729 EPAFile Symbol orRegistrationNumber: 74054-5 ProductName: MCW437 TECHNICAL EPAReceiptDate: 02-Dec-2010 EPA CompanyNumber: 74054 CompanyName: IRVITAPLANT PROTECTIONN.V.
Arm 

### Stout MAKHTESHIM-AGAN OF NORTHAMERICA INC IRVITA PLANTPROTECTIONN.V. 4515 FALLS OF NEUSERD STE 300 RALEIGH, NC 27609- OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration Amendment Subjectto Registration Service Fee
DearRegistrant:
The Office ofPesticide Programs has received your amendment and certificationof payment. Ifyou submitted datawiththis application, the results ofthe PRN-86-5 screenwill be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has determined thatthis Actionis subjectto a Pesticide Registration Service Fee as defined in thePesticide RegistrationImprovementAct.
The Actionhas been identified as ActionCode: R340
NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTIONARYLABEL STATEMENTS;SOURCE CHANGES TO ANUNREGISTERED SOURCE);
No additionalpayment is due atthis time.
Ifyouhave any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362. Sincerely,

## ~

# Fr~' taff

- / InfO/iiIOn echn logy & 

### Resources ManagementDivision 

# :/!/

## MANA

OVERNIGHTDELIVERY
Richard Gebken (PM 10) DocumentProcessing Desk (REGFEE) Office ofPesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202
RE: IrvitaPlant Protection N.V. November29,2010

MCW437Technical (EPA File Symbol 74054-5) Application for Amended Pesticide Registration PRIA Category R340
DearMr. Gebken, 

### 483108..00

On behalfofIrvita Plant Protection N.V., we are submitting an application to amend the registration of MCW 437 Technical to add an alternate source. In addition, the label has been revised to add outdoor uses. In support ofthis application, we submitthe following documents:
1. 

### Application for an Amended Pesticide Registration (EPA Form 8570-1) 2. Confidential Statement ofFormula(EPAForm 8570-4) for Alternate CSF#1 3. Three (3) Copies ofthe Proposed Labeling 4. A CD containing an electronic version ofthe proposed labeling 5. Certification with Respectto Label Integrity 6. Certification with Respectto Citation ofData(EPA Form 8570-34) 7. Agency Internal UseCopy ofthe Data Matrix 8. Public File Copy ofthe DataMatrix 9. Copy ofPRIApayment 10. LetterofAuthorization II. Product Specific Data (3 copies ofeach report):


### 48310801 Volume I 830.1550,830.1600, Tillman, A. M. Product Identity and Composition, Description of 830.1620, 830.1670, the Materials Used, Description of the Production Process, 

### 830.1750,830.1800 Discussion of the Formation of Impurities, Certified Limits and EnforcementAnalytical Method for MCW 437 Technical. Contains ConfidentialBusinessInformation. 

### 48310802 Volume 2 830.1700, 830.1800 Vaida, M. Technical MCW 437 Determination of Active Ingredient and Impurities Present at or above 0.1% 

### in Five Batches. Contains ConfidelllialBusinessInformation.

### 48310803 48310804
48310805

48310806
48310807 48310808 48310809 48310810
48310811 Volume 3 830.1700
Volume 4 830.1700
Volume 5 830.6313,830.6315, 830.6316, 830.6317, 830.6319,830.6320, 830.6321,830.7100, 830.7220, 830.7520 Volume 6 830.6302, 830.6303, 830.6304 Volume 7 830.7000 Volume 8 830.7050 Volume 9 830.7200 Volume 830.7300 10 Volume 830.7300 11 R. Gebken Nov. 29, 2010 Page 2 of2
Pisarev, V. Determination ofWater and Solvent in Five Batches of Technical Fipronil. Contains ConfidentialBusinessl1iformation. 

### Gorban, I. 

### Fipronil Technical (MCW 437) Confirmation ofAnalyte Identification. Contains ConfidentialBusinessInformation. 

### Tillman, A. M. MCW 437 Technical Summary of and Waiver Requests for Phys-Chem Properties.

Walter, D. Physical State, Colour and Odour of MCW 437 Technical. Walter, D. pH ofan Aqueous Dilution ofMCW437 Technical. Walter, D. UVlVis Absorption Spectrum ofMCW437 Technical. Walter, D. Melting Temperature ofMCW437 Technical. Walter, D. PourandTap Density ofMCW 437 Technical. Walter, D. Relative Density ofMCW437 Technical.

We would like to note that Irvita Plant Protection N.Y. is using the selective method ofsupport. As per EPA's interpretations of40 CFR Parts 152.86(b)(2)(i) and 152.93(b)(2)(i), Irvita Plant Protection N.V. submitted notices ofintent to apply and offers to pay to all companies on the September 30, 2010 Data Submitter's List. This action falls under PRIA category R340 (54: Amendment requiring data review within RD) because it is an application to add a new source for the technical product. The fee for this action is $3,617 and has been paid. The decision timeline is 4 months. We trust you will find this application complete. However, please feel free to contact me ((253) MS3- 

### 7369, Ann@PyxisRC.com) ifyou have any questions or need any additional information.
Sincerely,

Ann M. Tillman

EnclosuresPt. •••**r~·"**jft.t,.'-:o_

...**~ -~.**  "for. comnletJ,w. to,.... 

# . ......**.n~** Ann,ov"_ OM" Nn. 

# l.vnI._ 1.1•.•• 

# \i" " 

# §Registration opp Identifier Number 

# &EPA United States 

### Environmental Protection Agency of 

### Amendment Washington, DC 20460 

### Other Application for Pesticide

- Section I 1. Compeny/Product Number .' 2. EPA Prod.';ct Maneger 3. Proposed Classification Irvita Plant Protection N.V.i74054·5

. R. Gebken: 

# 0 None 

# o Restricted 4. CQmpany/Product INeme) .' PM' 

### • " Irvita Plant Protection N.Y.lMCW 437 Technical 

### , 

## , 10 

# '" 5, Neme end Address of Applicant (Includ6 ZIP Codel 6, Expedited**Rev~a~nce** with FIFRA Section 3(c)l31

Irvita Plant Protection N.Y. (bl/il, my

### P~cf"'IS similar

### ~t(n 'fal in composition and labeling c/o Pyxis Regulatory Consulting, Inc. 4110 136th SI. NW

## t~~A Reg: 'No, 

## 7969-243 ./ Gig Harbo" WA 98332 

## '**~** 

# o Check ifthis is I!I new Bddress P d N

## ~FiprOnjneChnical ro uct arne 

### Section

- II 

# 0 Amandment· Explain below. 

# U Final printed labels in repsonse to

. 

## . Agency lener dated 

# 0 Resubmission in response to Agency laner dated 

# 0 "Me Too" Application. 

# 0 Notification· Explain below. 

# 0 Other· Explain below.

•• Explanation: Usa addltionel pagels) if nacessary. tFor section Iand Section 11.) 

### , , 

# . , , This application falls underCategory R340 (54: Amendment requiring data review within RD) becausa)t;s an arrlicstion to add a new source for a currently registered product. The fee which has been paid is $3,617 and the dedsion timelire**is~** months.



### Section

- 11\ 

# .... 1. Matarlal Thle Product Will 

### a. Packaged In: 

### •• Child·Resistant Packaging Unit Peckaging Water Soluble Packaging 2. Type of Container

### ~yo. 

# @Y•• 

# @ Yo.

.0: 

# l;r of No 

### of No No ?tastJc Glass
• Certification mUllt If "Yes" No. per If "Yas" No. per Paper lined fiber drum Unit Packsging wgt. container Peckage wgt container ./ Other (Specify) btl lIubmfttfJd I 3. Location of Net Contants Information 4. Size!s) Ratail Container 

# 15. Location of Labal Directions J On Label 

### [{. Label 

# U Container 25 kg 

## t.....:cj On Lilbollngaccompanying product 6. Manner In Which Label is Affixed to Product 

# L:J Uthogreph 

# U Other J Paper Pe'ued Stenci ed

### Section

- IV 1. Contact Point (Complflttt ifttm$ dirttctly below for idttntification ofindividual ro btt contacted, ifnecfl3Sary, toprocMs fhi$ application.) N'ame Title Telephone No. (Include Area Code) Pyxis Regulatory Consulting, Inc. Agent (253)-853-7369 Certification 6. Dete Application Icertify that tha statements Ihave made onthis form and all attachments thereto- are true, accurata and completa. Received Iacknowladga that any knowlingllv falsa or misleading statement may be punishable by fine orimprisorvnent or (Stamped) both undar applicable law. .2. Signature

# Il''')A-~ 3. Titla ConSUltant

4. T'(pad Nama 5. Date Ann M. Tillman 

# 11/->1)/0

EPA Form 8570·1 !R.v. 3·94, PreVIouS editions are obsoleta. WhIt••EPA Filo Copy (origin_" Ydow •Applcant Copy



# ..Form Approved OM8 No. 2070-0060

...... ft

.....· 

## if UNITED STATES ENVIRONMENTM: PROTECTION AGENCY

## \~l 401 M Street, S.W

. 

# . -' WASHINGTON, D.C. 20460
Paperwork ReductIonAct Nottce: The public reporting burden for this collegion of information is estimated to average 1.25 hours per response for registration and 0.25 hours per response forreregistration and specia' review**activitles,;~** time .forreading the hstructions and**ccm~eting** the necessary forms. Send comments regarding burden estimate or any other aspect ofthiS collection 0 ation, Includmg suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S, Environmental Protection Agen ,401 M Street, S.w., Washington, DC 20460. Do notsend the completed form to this address. Certificationwith Respectto Citation ofData**Appncant'S/Re~lstranrs** Name, Address, and Telephone Number EPA ReQistration NumbertFile Symbol INiia Plant Prolection N.V. clo Pyxls Regulalory Consulting 4110 136111 51. NWGig Hllrbor, WA 98332.253· 853--7369 74054·5 Active InQredient(s) andlor reoresentativetest comoound(s) Date F!pronil Nov. 29, 2010 General Use Pattem(s) (list all those claimed forthIs product usinQ 40 CFR Part 158) Product Name Indoor non·food; Residential in·door/outdoor; Terrestrial non·food; Greenhouse non·food MeW 437 Technical NOTE: Ifyour product is a 100% repackaging ofanother purchased EPA·registered product labeled for all the same uses on your label. you do not need to submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570·27). 

# 0 I am responding to a Data-CalHn Notice, and have included with this form a listofcompanies sent offers ofcompensation (the Data Matrix form should be used for this purpose).

SECTION I: METHOD OF DATA SUPPORT(Check one method only) 

# 0 I am using the clte·aU method ofsupport, and have included with this form 

# [2] I am using the selective method ofsupport (orcite·all option a list ofcompanies sent offers ofcompensation (the Data Matrix form underthe selective methOd). and have induded with thisform a should be used for thIs purpose). completed list ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFER TO FAY (Required ifusing the dte·all method orwhen using the dte·all option under the selective method to satisfy one or more data requirements] 

# [2] I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.

SECTtON tit: CERTIFICATION
I certifythatthis application for registration, this form for reregistration, orthis Data·Call·ln response is supported by all data submitted orcited in the application for registration, the form for reregistration, or the Data·Call·ln response. In addition, ifthe cite·all option orcite·all option underthe selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties oreffects ofthis product or an Identical or substantially similar product, orone or more ofthe ingredients in this product; and (2) is a type ofdata thatwould be required to be submitted underthe data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration ofa product of identical or similar composition and uses. I certify that for each exclusive use study cited in support ofthis registration or reregistration, that I am the original data submitterorthat I have obtained 'tilewritten permissIon ofthe original data submitterto cite that study.
Icertify that for each study cited in support ofthis registration or reregistration that is not an exctusive use study, either: (a) I am the original data submitter; (b) I have obtained the permission ofthe original data submitterto use the study in support ofthis application; (c) all perlOdS ofeligibilify for compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the st..c:,. a,**I~** I,ave offered (I) to pay compensatIon to the extent required by sections 3(c)(t)(F) andlor3(c)(2)(8) ofFIFRA; and (Ii) to commence negotiations to determine the amount and terms ofcompensation, ifany, to be paid for the use ofthe study.
Icertify that in all instanceswhere an offerofcompensation is required, copies ofaU offers to pay compensation and e,vidl1nce oftheir delivery in accordance with sections 3(c)(1)(F) andlor 3(c)(2)(8) ofFIFRA are available and wtll be submitted to the Agency upon request**Bh~'Jld** Ifail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel orsuspend the registra\i,)O ofmy'product in'cl.Ir',rOIr;rlity with FIFRA.
I certIfy that the statements I have made on thts form and aU attachments to It are true, accurate, and comptete, I' acknowlejgL- th'al any knowtngty false ormisteadlng statement may be punIshable by fine or Imprisonmentor both under applicable law•

.. , 

## .**~ignature**

# a-<-<A)u~ Date Typed or Printed Name and Title Nov, 29, 2010 Ann M. TIllman, Consultant EPA Form 8570-34 9·97 Electronic and Pa erversions available. Su mit onl p b Pa r y pe version.

## PYXIS REGULATORY CONSULTING, INC. 4110136 St. NW Gig Harbor, WA 98332

November23, 2010 VIA CERTIF!ED MAIL, 

### RETIJRN RECEIPTREQUESTED 70101060000250661681 BASFCorpnration Agricultural Products PO Box 13528 Research Triangle Park, NC 27709

RE: Fipronil Offer-to-Pay
To Whom It

### MayConcern: Phone: 253-853-7369 Fax: 253-853-5516 www.PyxisRC.com

IrvitaPlantProtection N.V. (lrvita) is applyingfor an amendedregistrationundertheFederal Insecticide, Fungicide, and Rodenticide Act ("FlFRA"), 7 U.S.C. 

### § 136 

### etseq., for its technical product called "MCW 437 Technical", containingfipronil as the active ingredient. Irvita's amendmentuses the selectivemethod ofdata support (40 C.F.R. 

### §§ 152.90

- 152.96). For many guideline requirements, lrvita's application cites data previously submitted by BASF orrelies on the "cite-aU method within selective" method. Attachment I hereto lists the guidelines for which lrvita's application uses the cite-all under selective method. Attachment2 lists the specific studies cited in Irvita's application. We hereby provide ournotice ofintentto apply and our offerto

### pay compensationto BASF, to the extentrequiredby FIFRA 

### § 3(c){l)(F), for the data cited in Irvita's amendment(seeAttachments I and**2~** 

### providedthatBASF is identifiedby EPA asthe "original datasubmitter" for such data. Further, wehereby offerto commencenegoiations to determinethe amountandterms ofcompensation, ifany, duefortheso studies. Please note that, in accordance with 40 C.F.R. 

### § 152.93{bX3), Irvita is not offering to pay for studies originally submittedto theEPA on orbefore the date that is 15 years beforethe date ofIrvita's application for amendmentof the above-mentioned product. However, as set forth in FIFRA §

### 3(c)(I)(F) and as affinned by EPA, only data originally submitted within 15 years ofEPA's approval oflrvita'samendmentare eligiblefor compensation Ifyou are aware ifany studies listed in Attachment2 do not satisfY applicable data requirements, please advise us within the next 60 days. Please also advise us whether you have submitted a replacement study to 

### satisfY the applicable data requirement and, if so, the guideline number, study title, and MRID number of each such replacement study. Wereservetherightto revise this offerto payuponreceivingthis information from you. Ifany ofthe studies listed in Attachment2do not satisfYthe applicable datarequirementandyouhave notsubmitted acceptable replacementstudy(ies),Werequestthatyou notifY us thatadatagap exists. Unless wehearfrom you, we 

### will understand that there are no outstanding data requirements and Irvita 

### will not claim a data gap for any data requirements. Thankyou very much foryourcooperation.

# ~ lanelle Kay AgentforIrvitaPlantProtection N.V.

cc: E. Gur; Makhteshim-AganofNorthAmerica, Inc. K. Venkatesh; Makhteshirn-AganofNorth America, Inc. Attachments

## Attachment 1. Irvlta Plant Protection N.V. MeW

## 437 Technical Offer-to-Pay
Guideline Number Guideline Title 850.2300 (71-4(a)) Avian ReproductiveToxicity: Quail 850.2300 (71-4(b)) Avian ReproductiveToxicity: Duck 850.1075 (72-3(a)) Estuarine/Marine Fish Toxicity 850.1400 Early Ufe Stage: Fish Saltwater 850.1300 (72-4(b)) Early Life Stage:Aquatic Invertebrate 870.3250 (82-3) gO-Day DermalToxicity 870.6200 90-Dav Subchronic Neurotoxicity-Rat 870.3700 (83-3) Prenatal DevelopmentToxicity Studies 870.3800 (83-4) Reproduction and FertilityEffects 870.6300 (83-6) Developmental NeurotoxicityStudy 870.5100 (84-2(a)) Bacterial Reverse MutationTest 870.5300, 870.5375 (84-2(b)) 

### In vitro Mammalian Cell Gene MutationTest 870.5385,870.5395 (84-4) 

### In vivo Cytogenetics 870.7485 Metabolism and Pharmacokinetics 870.7800 Immunotoxicity 850.4100 (122-1(a)) Tier 1: Seed Germination and Seedling Emergence 850.4150 (122-1(b)) Tier 1:Vegetative Vigor 850.4400 (122-21 Tier 1: Aquatic Plant Growth 850.3020 (141-1) Acute ContactToxicity: Honey Bee 835.2120 (161-1) Hydrolysis 835.2240 (161-2) Photodegradation in Water 835.4100 (162-1) Aerobic Soil Metabolism 835.4200 (162-2) Anaerobic Soil Metabolism 835.4300 (162-3) AnaerobicAquatic Metabolism 835.4400 (162-4) AerobicAquatic Metabolism 835.1230,835.1240 (163-1) Leaching and Adsorption/Desorption 835.1410 Volatility

- Laboratory 835.8100 Volatility

- Field

Page 1

## Attachment 2. Irvita Plant Protection N.V. MeW

## 437 Technical Offer·to·Pay
43884003 44138301 44262801 44262802 44262803 44262808 44262812 44262816 44262819 44262820 44262828 44262829 44298002 44299401 44350001 44350002 44350004 44350005 44431801 44506901 44605504 44605505 44884101 44890301 44890302 44963501 45120001 45120002 45135902 45156301 45156302 45175901 45259201 45259202 45259203 45298001 45298002 45375901 45393301 45509803 45520301 45632301 45644701 45878001 46215103 46329902 46329903 46329905 46376701 46490301 46490302 46490303 46490304 46490304 46490305 46619103 46733901 46733902 46733903 46733904 46733905

Page 1Sarah Greubel From: Sent: To: Ann Tillman Tuesday, November 30, 2010 1:29 PM Sarah Greubel Subject: FW: Pay.Gov Payment Confirmation -Irvita MCW437 TEchnical



### Ann
-----Original Message----- From: paygovadmin@mail.doc.twai.gov [mailto:pavgovadmin@mail.doc.twai.gov] Sent: Tuesday, November 30, 2010 2:42 PM To: Kris Venkatesh Subject: 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: 2520SMTG Agency Tracking ID: 74156235697 Name On Account: Makhteshim Agan of NA Transaction Type: ACH Debit Transaction Amount: $3,617.00 Payment Date: Dec 1, 

### 2010 Account Type: Business Checking Routing Number: Account Number: ************7618 Transaction Date: Nov 30, 2010 2:41:42 PM Number of Payments Scheduled: 1 Frequency: OneTime Decision Number: Registration Number: 74054-5 Company Name: Irvita Plant ProtectionNV Company Number: 74054 Action Code: R340

1

# Certification with Respect to Label Integrity
version: **9/11/02**



### I certify that the information (including, but not limited to, text, tables, and graphics) contained in the electronic file identified below by file name and submitted with this certification is the same information as that on the paper copies ofthese documents included with this submission.

IPROPOSED LABEL 

### Date Submitted EPA 

### Registration 

## # to EPA 

### Electronicfile name
074054-5 November 29, 074054-5.20101118.MCW437 Technical 2010 label v4.pdf

I certify that the statements that I have made on this form are true, accurate, and complete. I acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment or both under applicable law.

Signature Ann M. Tillman Consultant, Irvita Plant Protection N.v. Nov. 29,2010 DateJanuary 28, 2009

Document Processmg Desk (7504P) U, S, Environmental Protection Agency One Potomac Yard 2777 S, Clystal Drive Arlington, VA 22202

To whom it may concern

The purpose ofthis letter is to inform you thaI Pyxis RI!9ulatory Cl)nsultants, LLC IS a regulatory company employed by Irvita Plant Protection NV (ltvlia) and will Je filing applicalion(s) for FIFRA registratiOI1(s) on our behalf. The official agent on file at EPA should siill be Makhte;him Agan It! North America, Inc, at 45'15 Fails ofNeuse Road, Suile 300, Raleigh, NC 27609, Should you have any other questions 

### or comments, p!,:;ase do not hesitate to contact me,

Sincerely, Irvila Plant Protection

David Hebel General ManagerForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

## I Page 

## I of20 Applicant's/Registrant's Name &Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note Product Specific Data Requirements 830.1550 Product Identity and Composition 47723901 Irvita Plant Protection NV OWN 830.1600 Description of Materials Used to Produce the 47723901 Irvita Plant Protection NV OWN Product 830.1620 Description of Production Process 47723901 Irvita Plant Protection N.V. OWN 830.1650 Description of Formulation Process Not Required' 830.1670 Discussion of Formation of Impurities 47723901 Irvita Plant Protection N.V. OWN 830.1700 Preliminary Analysis 47723902 Irvita Plant Protection NV OWN 830.1750 Certified Limits 47723901 Irvita Plant Protection NV OWN 830.1800 EnforcementAnalytical Method 47723901 Irvita Plant Protection NV OWN ';7723902**·~n23gU3** .-- 830.6302 Color 

### 41723905 Irvita Plant Protection N.V. OWN 830.6303 Physical State 47723905 Irvita Plant Protection N.V. OWN 830.6304 Odor '... 477239;)5

# --+ Irvi!a Plant Protection NV OWN Signature .. I, Name'and Title Date

# ~~[,~ .**\~** Ann M. Tillman, Consultant Nov

. 23,2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reo. No.lFile Svmbol 74054-5 

# I Paqe2.of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection N.V. MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 830.6313 Stability to Normal and Elevated Temperatures, 47723906 Irvita Plant Protection NV OWN Data Metals, and Metal Ions 830.6314 Oxidation/Reduction: Chemical Incompatibility 47723907 Irvita Plant Protection NV OWN Data 47723904 Waive(- 830.6315 Flammability 47723904 Irvita Plant Protection N.V. OWN Waiver' 830.6316 Explodabilitv 47723904 Irvita Plant Protection N.v. OWN Waiver' 830.6317 Storage Stability 48293101 Irvita Plant Protection NV OWN 830.6319 Miscibilitv 47723904 Irvita Plant Protection NV OWN Not Reauired5 830.6320 Corrosion Characteristics 48293101 Irvita Plant Protection NV OWN 830.6321 Dielectric Breakdown Voltaqe Not Reauired5 830.7000 pH 47723908 Irvita Plant Protection NV OWN 830.7050 UVNisible Absorption 47723909 Irvita Plant Protection NV OWN 830.7100 Viscosity 47723904 Irvita Plant Protection NV OWN Waiver 5 830.7200 Meltinq PointiMeltinq Ranqe 47723910 Irvita Plant Protection NV OWN 830.7220 Boiling PointiBoiling Range 47723904 Irvita Plant Protection N.V. OWN Not Reauired6 Signature Name and Title Date

# 4L~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# I Paae3of20 Applicant's/Registrant's Name &Address Product Irvita Plant Protection NY MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRtD Number Submitter Status Note 830.7300 Density/Relative Density/Bulk Density 47723911 Irvita Plant Protection N.V. OWN 47723912 830.7370 Dissociation Constants in Water 47723913 Irvita Plant Protection NY OWN 830.7520 Particle Size, Fiber Length, and Diameter 47723904 Irvita Plant Protection NY OWN Not Required 5 Distribution 830.7550 Partition Coefficient (n-octanol/water), Shake 47723914 Irvita Plant Protection NY OWN Flask Method 44350004 BASF Corporation PAY 44350005 BASF Corporation PAY 830.7560 Partition Coefficient (n-octanollwater), See 830.7550 Generator Column Method 830.7570 Partition Coefficient (n-octanol/water), See 830.7550 Estimation by Liquid Chromatography 830.7840 Water Solubility: Column Elution Method; 47723915 Irvita Plant Protection NY OWN Shake Flask Method 44350001 BASF Corporation PAY 44350002 BASF Corporation PAY Signature Name and Title Date

# a-~~ Ann M. Tillman, Consultant Nov.23,2010

EPA Form 8570 M35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 

### 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 

### 0.25 hours per response for registration activities and 

### 0.25 hours per response for rereg'lstration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division 

### (2137), U.S. Environmental Protection Agency, 

### 401 M Street, SW., Washington, DC 

### 20460. Do not send the form to this address. DATA MATRIX Date Nov. 

### 23, 2010 EPA ReQ. No.lFile Symbol 

### 74054-5 

# I PageL.j of

### 20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW

### 437 Technical Pos Cabai Office Park Unit 

### 13 POB 

### 403 Curacao, Netherlands Antilles InQredient Fipronil (CAS No. 

### 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

### 830.7860 Water Solubility, Generator Column Method See 

### 830.7840 830.7950 Vapor Pressure 

### 47723916 Irvita Plant Protection NV OWN 

### 44262801 BASF Corporation PAY 

### 44262802 BASF Corporation PAY 

### 44262803 BASF Corporation PAY


### 870.1100 Acute Oral Toxicity: Rat 

### 47723917 Irvita Plant Protection NV. OWN 

### 43235401 OLD 

### 43279706 OLD 

### 44262819 BASF Corporation PAY 

### 43291715 OLD 

### 43291720 OLD 

### 870.1200 Acute Dermal Toxicity: Rat 

### 47723918 Irvita Plant Protection NV OWN 

### 43235402 OLD 

### 44262820 BASF Corporation PAY Signature Name and Title Date

# 4L1.~ Ann M. Tillman, Consultant Nov. 

### 23, 2010

EPA Fonn**8570~35** (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, SW.,Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

## I Page::> of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NY MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 870.1300 Acute Inhalation Toxicity: Rat 47723919 Irvita Plant Protection NY OWN 870.2400 Primary Eye Irritation: Rabbit 47723921 Irvita Plant Protection NY OWN 870.2500 Primary Dermal Irritation 47723920 Irvita Plant Protection N.V. OWN 870.2600 Dermal Sensitization 47723922 Irvita Plant Protection N.V. OWN
Generic Data Requirements 850.2100 (71-1(a» Acute Avian Oral Toxicity: Quail or Duck 42918617 OLD See endnote7 42918618 OLD 43776601 OLD 850.2200 (71-2(a» Acute Avian Dietary Toxicity: Quail 42918620 OLD See endnote8 44890301 BASF Corporation PAY 44890302 BASF Corporation PAY 45259201 BASF Corporation PAY 850.2200 (71-2(b» Acute Avian DietaryToxicity: Duck 42918621 OLD See endnote9 850.2400 (71-3) Wild Mammal Toxicity Not required'

# ° Signature Name and Title Date

# .t2-1.~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W, Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No'/File Symbol 74054-5 

# I**Page~f20** Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW 437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference NUmber Guideline Study Name MRID Number Submitter Status Note 850.2300 (71-4(a)) Avian Reproductive Toxicity: Quail Cite-all PAY 850.2300 (71-4(b)) Avian Reproductive Toxicity: Duck Cite-all PAY 850.1075 (72-1) Freshwater Fish Toxicity 44299401 BASF Corporation PAY 850.1075 (72-1 (a),(b)) Fish Toxicity: Bluegill 42918624 OLD See endnote11 42918674 OLD 43279702 OLD 850.1075 (72-1 (c),(d)) Fish Toxicity: Trout 42977902 OLD See endnote12 43291718 OLD 42918673 OLD 43279703 OLD Signature Name and Title Date

# tL.h.~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. NoJFile Symbol 74054-5 

## I PaQej of20 Applicanfs/Registranfs Name &Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 850.1010 (72-2(a)(b)) Freshwater Invertebrate Toxicity 42918625 OLD See endnote13 44138301 BASF Corporation PAY 42918669 OLD 42918671 OLD 43291719 OLD 46329902 BASF Corporation PAY 46329903 BASF Corporation PAY 46329905 BASF Corporaflon PAY 46376701 BASF Corporation PAY 850.1075 (72-3(a)) Estuarine/Marine Fish Toxicity Cite-all PAY 850.1025 (72-3(b)) Estuarine/Marine MOllusk Toxicity 43291701 OLD See endnote14 850.1035 (72-3(c)) Estuarine/Marine Shrimp Toxicity 43279701 OLD See endnote15 45120001 BASF Corporation PAY 45156301 BASF Corporation PAY 45156302 BASF Corporation PAY Signature Name and Title Date

# a...~~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# I Page't) of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 850.1400 (72-4(a)) Early Life Stage: Fish Freshwater 42918627 OLD See endnote16 850.1400 Early Life Stage: Fish Saltwater Cite-all PAY 850.1300 (72-4(b)) Early Life Stage: Aquatic Invertebrate Cite-all PAY 850.1350 Aquatic Invertebrate Life Cycle (Saltwater) 43681201 OLD See endnote17 45259202 BASF Corporation PAY 45298001 BASF Corporation PAY 45298002 BASF Corporation PAY 45259203 BASF Corporation PAY 46619103 BASF Corporation PAY 850.1500 (72-5) Life Cycle Fish Not required 18 850.1710, 850.1730, Aquatic Organisms Bioavailability 43291706 OLD See endnote19 850.1850 43291707 OLD 44298002 BASF Corporation PAY 45375901 BASF Corporation PAY Signature Name and Title Date

# a..~~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Fonn 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# I Page'1 of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRIO Number Submitter Status Note 850.1950 Simulated or actual field testing for aquatic Not required 20 organisms 850.1735 Whole sediment: Acute Freshwater 45175901 BASF Corporation PAY Invertebrates 45878001 BASF Corporation PAY 850.1740 Whole sediment: Acute Marine Invertebrates Not required 21

870.6200 (81-8) Acute Neurotoxicity (Rat) 44262808 BASF Corporation PAY See endnote22 42918635 OLD 44431801 BASF Corporation PAY 870.3100 (82-1 (a)) 90-Day Oral Toxicity in Rodents 42918643 OLD See endnote23 43501701 OLD 43559501 OLD 44963501 BASF Corporation PAY 870.3150 (82-1(b)) 90-Day Oral Toxicity in Non-Rodents 42918642 OLD See endnote24 44262812 BASF Corporation PAY Signature Name and Title Date

# 4L~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570*35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Re.& No.!File Symbol 74054-5 

# I Pagel{)of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRIO Number Submitter Status Note 870.3200 (82-2) 21-Day Dermal Toxicity Not required 25 870.3250 (82-3) 90-Day Dermal Toxicity Cite-all PAY 870.3465 (82-4) 90-Day Inhalation Toxicity Not required'6 870.6100 28-Day Delayed Neurotoxicity

- Hen Not required'7 870.6200 90-Day Subchronic Neurotoxicity -Rat Cite-all PAY 870.4100 (83-1 (a» Chronic Toxicity Rat 42918648 OLD See endnote" 43884003 BASF Corporation PAY 870.4100 (83-1(b» Chron"rc Toxicity Dog Not required'9 870.4200 (83-2(a)) Carcinogenicity Rat 42918648 OLD See endnote3O 43884003 BASF Corporation PAY 870.4200 (83-2(b» Carcinogenicity Mouse 42918649 OLD See endnote31 43501702 OLD 870.3700 (83-3) Prenatal**Develo~ment** Tox·lcity Studies Cite-all PAY 870.3800 (83-4) Reproduction and Fertility Effects Cite-all PAY 870.6300 (83-6) Developmental NeurotoxicityStudy. Cite-all PAY Signature Name and Title Date

# 4L.1~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

## I Page

# II of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pas Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 870.5100 (84-2(a)) Bacterial Reverse Mutation Test Cite-all PAY 870.5300, 870.5375 (84-2{b)) In vitro Mammalian Cell Gene Mutation Test Cite-all PAY 870.5385,870.5395 (84-4) In vivo Cytogenetics Cite-all PAY 870.7200 Companion Animal Safety See endnote3' 870.7485 Metabolism and Pharmacokinetics Cite-all PAY 870.7600 (85-2) Dermal Penetration 43737308 OLD See endnote33 44262816 BASF Corporation PAY 870.7800 Immunotoxicity Cite-all PAY
850.4100 (122-1(a)) Tier 1: Seed Germination and Seedling Cite-all PAY Emergence 850.4150 (122-1(b)) Tier 1 :VeQetative Vigor Cite-all PAY 850.4400 (122-2) Tier 1: Aquatic Plant Growth Cite-all PAY
875.1100 Dermal Outdoor Exposure AHETF AHETF OWN See endnote34 Signature Name and Title Date

# 4L~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA ReQ. No.lFile Symbol 74054-5 

# I Pagellof20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 875.1200 Dermal Indoor Exposure AHETF AHETF OWN See endnote35 44433302 Merial Limited PAY 44433303 Merial Limited PAY 875.1300 Inhalation Outdoor Exposure AHETF AHETF OWN See endnote'S 875.1400 Inhalation Indoor Exposure AHETF AHETF OWN See endnote" 45393301 BASF Corporation PAY 44433302 Merial Limited PAY 44433303 Merial Limited PAY 44433308 Merial Limited PAY 875.1500 Biological Monitoring AHETF AHETF OWN See endnote'S 875.1600 Data Reportinq and Calculations AHETF AHETF OWN See endnote" 875.1700 Product Use Information Label OWN
Signature Name and Title Date

# a..h.~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Fonn 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA ReQ. No.lFile Symbol 74054-5 

# I Pagel30f20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection N.V. MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles InQredient Fipronil (CAS No. 120068-37-3\ Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 875.2100 (132-1a) Foliar Residue Dissipation 44506901 BASF Corporation PAY 44531201 Merial Limited PAY 44531202 Merial Limited PAY 44531203 Merial Limited PAY 44531204 Merial Limited PAY 875.2200 Soil Residue Dissipation ARTF ARTF OWN See endnote4O ORETF ORETF OWN 875.2300 Indoor Surface Residue Dissipation ARTF ARTF OWN See endnote41 ORETF ORETF OWN 875.2400 (133-3) Dermal Passive Dosimetry Exposure See endnote42 875.2500 (133-4) Inhalation Passive Dosimetry Exposure See endnote43

850.3020 (141-1) Acute Contact Toxicity: Honey Bee Cite-all PAY 850.3030 (141-2) Honey Bee Toxicitv of Residues on Foliage 44884101 BASF Corporation PAY

Signature Name and Title Date

# a..~~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 

### 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 M Street, S.W. WASHINGTON, D.C. 

### 20460 Paperwork Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 

### 0.25 hours per response for registration activities and 

### 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division 

### (2137), U.S. Environmental Protection Agency, 

### 401 M Street, SW., Washington, DC 

### 20460. Do not send the form to this address. DATA MATRIX Date Nov. 

### 23, 2010 EPA ReQ. No.!File Symbol 

### 74054-5 

# I PagelL/of

### 20 Applicant's/Registrant's Name &Address Product Irvita Plant Protection NV MCW

### 437 Technical Pos Cabai Office Park Unit 

### 13 POB 

### 403 Curacao, Netherlands Antilles InQredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

### 835.2120 (161-1) Hydrolysis Cite-all PAY 

### 835.2240 (161-2) Photodegradation in Water Cite-all PAY 

### 835.2410 (161-3)**Photod~gradation** on Soil 

### 42918662 OLD See endnote« 

### 835.2370 (161-4) Photodegradation in Air Not required45 

### 835.4100 (162-1) Aerobic Soil Metabolism Cite-all PAY 

### 835.4200 (162-2) Anaerobic Soil Metabolism Cite-all PAY 

### 835.4300 (162-3) Anaerobic Aquatic Metabolism Cite-all PAY 

### 835.4400 (162-4) AerobicAquatic Metabolism Cite-all PAY 

### 835.1230,835.1240 (163-1) Leaching and Adsorption/Desorption Cite-all PAY 

### 835.1410 Volatility

- Laboratory Cite-all PAY 

### 835.8100 Volatility

- Field Cite-all PAY 

### 835.6100 (164-1) Soil Field Dissipation Study 

### 43291705 OLD See endnote46 

### 46215103 BASF Corporation PAY 

### 44262828 BASF Corporation PAY 

### 44262829 BASF Corporation PAY Signature Name and Title Date

# 4L.)z.~ Ann M. Tillman, Consultant Nov. 

### 23, 2010

EPA Fonn 8570-35 (9-97) Electronic and Paper versions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# IPage('§of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 835.6200 (164-2) Aquatic Sediment Field Dissipation Study Not required47 835.6300 (164-3) Forest Field DissijJation Study Not required" 835.7100 (166-1) Small-Scale Prospective Groundwater Study 46490304 BASF Corporation PAY 46490305 BASF Corporation PAY 46733902 BASF Corporation PAY 46733903 BASF Corporation PAY 46733904 BASF Corporation PAY 46733905 BASF Corporation PAY 44605504 BASF Corporation PAY 44605505 BASF Corporation PAY 45120002 BASF Corporation PAY 45509803 BASF Corporation PAY 45520301 BASF Corporation PAY 45135902 BASF Corporation PAY
Signature Name and Title Date

# 4L~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Fonn 8570*35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# I PaQet(oof20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles Inqredient FiQronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRIO Number Submitter Status Note 860 series Residue Chemistry Data requirements Not required Nonguideline Studies Nonguideline 46619103 BASF Corporation PAY 45632301 BASF Corporation PAY 45644701 BASF Corporation PAY 46490301 BASF Corporation PAY 46490302 BASF Corporation PAY 46490303 BASF Corporation PAY 46490304 BASF Corporation PAY 46733901 BASF Corporation PAY

Signature Name and Title Date

# ,a..~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Fonn**8570~35** (9-97) Electronic and Paperversions avallable. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# 1Paqel70f20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name 

# I MRID Number Submitter Status Note Irvita Plant Protection, NV will make offers-to-pay to the following companies on the data submitters list of Sept. 30, 2010. Cite-All under Selective Method utilized by Irvita Syngenta Crop Protection, Inc. PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita The Scotts Company PAY Plant Protection, N.V. Cite-All under Selective Method utilized by Irvita Bayer CropScience LP PAY Plant Protection, N.V. Cite-All under Selective Method utilized by Irvita Bayer Environmental Science PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Whitmire Micro-Gen Research PAY Plant Protection, NV Laboratories Cite-All under Selective Method utilized by Irvita Virbac AH, Inc. PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Sergeant's Pet Care Products PAY Plant Protection, N.v. Inc. Signature Name and Title Date

# 4L.~~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35**(9~97)** Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

## I Paqe

## Ii}of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NV MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, Netherlands Antilles InQredient Fipronil (CAS No. 120068-37-3) Guideline Reference NUmber Guideline Study Name MRIO Number Submitter Status Note Cite-All under Selective Method utilized by Irvita Reckitt Benckiser Inc. PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Cheminova

### NS PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita J. J. Mauget Co. PAY Plant Protection, N.V. Cite-All under Selective Method utilized by Irvita BASF Corp. PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Chemisco PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Makhteshim Chemical Works PAY Plant Protection, NV Ltd. Cite-All under Selective Method utilized by Irvita Control Solutions Inc. PAY Plant Protection, NV Cite-All under Selective Method utilized by Irvita Virbac PAY Plant Protection, NV Signature Name and Title Date

# a..~(lJL Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form 8570-35 (9-97) Electronic and PaperVersions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.w. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Reg. No.lFile Symbol 74054-5 

# 1Page\'1of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NY MCW437 Technical Pos Cabai Office Park Unit 13 POB 403 Curacao, NetherlandsAntilles Ingredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline StugyName MRID Number Submitter Status Note Cite-All under Selective Method utilized by Irvita Combat Insect Control PAY Plant Protection, NY Systems Cite-All under Selective Method utilized by Irvita Merial Limited PAY Plant Protection, NY Cite-All under Selective Method utilized by Irvita Spray Drift Task Force OWN See endnote49 Plant Protection, NY Cite-All under Selective Method utilized by Irvita Cheminova Inc. PAY Plant Protection, NY Cite-All under Selective Method utilized by Irvita Outdoor Residential Exposure OWN See endnote33 Plant Protection, NY Task Force Cite-All under Selective Method utilized by Irvita Agricultural Reentry Task OWN See endnote33 Plant Protection, N.V. Force Cite-All under Selective Method utilized by Irvita Ambrands PAY Plant Protection, NY Cite-All under Selective Method utilized by Irvita Innovative Pest Control PAY Plant Protection, NY Products Signature Name and Title Date

# 4Lh.~ Ann M. Tillman, Consultant Nov. 23, 2010

EPA Form**8570~35** (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMS No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collecflon of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date Nov. 23, 2010 EPA Req. No.lFile Symbol 74054-5 

# I PageU)of20 Applicant's/Registrant's Name & Address Product Irvita Plant Protection NY MCW437 Technical Pos Cabai Office Park Unit 13 POS 403 Curacao, Netherlands Antilles InQredient Fipronil (CAS No. 120068-37-3) Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note Cite-All under Selective Method utilized by Irvita FIFRA Endangered Species PAY Plant Protection, NY Task Force Cite-All under Selective Method utilized by Irvita Residential Exposure Joint PAY Plant Protection, NY Venture Cite-All under Selective Method utilized by Irvita Agricultural Handlers OWN See endnote" Plant Protection, NY Exposure Task Force Cite-All under Selective Method utilized by Irvita Loradochem, Inc. PAY Plant Protection, NY Cite-All under Selective Method utilized by Irvita Argite

- Fipronil LLC PAY Plant Protection, NY Cite-All under Selective Method utilized by Irvita Fipronex Solutions Inc. PAY Plant Protection, NY

Signature Name and Title Date

# a..~~ Ann M. Tillman, Consultant Nov. 23,2010

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use Copy

### Endnotes for Data Matrix for MeW437 Technical

1 

### 830.1650

_These data are not required forthe registration ofa manufacturing use product. See 830.1620 for production process information. 

### 2830.6314

_Irvita Plant Protection N.V. requests a waiver from this requirement for MCW 437 Technical based on the fact that this technical does not contain any oxidizing or reducing agents. Submitted data show MCW 437 Technical is not an oxidizer. Please refer to the Confidential Statement of Formula for MCW 437 Technical. 

### 3830.6315

_Irvita Plant Protection N.V. requests a waiver from the requirement for flammability for MCW 437 Technical based on the fact that this technical is a solid and is not expected to be flammable. Please referto the Confidential Statement of Formula for MCW437 Technical. 

### 4830.6316

- Irvita Plant Protection N.V. requests a waiver from the requirement of this study. MCW 437 Technical does not have the chemical bonds orfunctional groups associated with explosive chemicals. Please refer to the Confidential Statement of Formula for additional information on the composition of MCW 437 Technical.
5 

### 830.6319, 830.6321, 830.7100, 830.7520

- MCW 437 Technical is a solid and not an emulsifiable concentrate and is not to be diluted with petroleum solvents. Therefore, miscibility data are not required for this technical. MCW 437 Technical is not to be used around electrical equipment and data for dielectric breakdown constant are not required. MCW 437 Technical is a solid and not a liquid, therefore, viscosity data are not required for this product. Irvita Plant Protection N.v. is seeking a waiver for particle size, fiber length and diameter distribution because MCW437 Technical is not water insoluble nor is it a fibrous material.

6 

### 830.7220

- MCW 437 Technical is a solid and boiling point data are not required for solids. Data for melting point are required for solids. See Guideline 830.7200. 

### 7850.2100 -42918617 is considered acceptable as pera March 11, 1994 Data Evaluation Record (DER) (Note: only two species are now required to be tested). 42918618 was originally classified as supplemental as per a March 21, 1994 review because it was not a recommended spec'les (house sparrow). This species is now a required species and, as such, this study is cited. 43776601 was considered acceptable as per an Oct. 20, 1995 EPA review.


### e 

### 850.2200

- 42918620 is considered acceptable as per a March 11, 1994 Data Evaluation Record (DER). 

### 9850.2200

- 42918621 is considered acceptable as per a March 9, 1994 Data Evaluation Record (DER).

10 

### 850.2400

- Data on wild mammal toxicity are not required; surrogate mammalian toxicity data are available. In addition, no data have been submitted to support this guideline requirement.
11 

### 850.1075

- 42918624 is considered acceptable as per a March 21, 1994 Data Evaluation Record (DER). 42918674 is considered acceptable as per a March 9, 1994 Data Evaluation Record (DER). 

### 12850.1075

_ 42977902 is considered acceptable as per a March 21, 1994 Data Evaluation Record (DER). 43291718 is considered acceptable as per a Jan. 10, 1995 Data Evaluation Record (DER). 42918673 is considered acceptable as pera March 21, 1994 Data Evaluation Record (DER).

13 

### 850.1010

- 42918625 was not considered acceptable in a May 6, 1994, but was upgraded with 44138301 as per Jan. 10, 1995 DER. 42918669 is considered acceptable as per March 21,1994 EPA review. 42918681 is considered acceptable as per March 21, 1994 EPA review. 43291719 is considered acceptable as perJan. 10, 1995 EPA review. 

### 14850.1025

- 43291701 is considered acceptable as per Jan. 10, 1995 EPA review. 

### 15850.1035

- 43279701 is considered acceptable as per Jan. 10, 1995 EPA review and August 29, 1995 EPA review. 

### 16850.1400

- 42918627 is considered acceptable as per March 21, 1994 EPA review.

Page 

### 1**of~**

### Endnotes for Data Matrix for MeW437 Technical

17 

### 850.1350

_ 43681201 is considered acceptable as perAugust 10, 1995 EPA review.

18 

### 850.1500

- Data are not required. Data were not submitted for the original registration, nor were data required to be submitted as a condition of registration.

19 

### 850.1710, 850.1730, 850.1850

- 43291706 and 43291707 were not considered acceptable as per Sept. 18, 1995 EPA review; it requested additional information on storage stability of tissue samples. These data appear to have been submitted with 44298002. 

### 20850.1950

- Data are not required. Data were not submitted for the original registration, nor were data required to be submitted as a condition of registration.

21 

### 850.1740

_ Data are not required; no data have been submitted to satisfy this data requirement.

22 

### 870.6200

- 44262808 is acceptable per May 22, 1998 EPA review. 42918635 is acceptable as per Sept. 22,1994 EPA review. 44431801 is acceptable per May 22,1998 EPA review. 

### 23870.3100

_ 43559501 is acceptable as per May 22, 1998 EPA review. 44963501 is acceptable as per May 22,1998 EPA memo. 42918643 was originally considered supplemental as per March 10, 1994 EPA review (upgradable with submission of neurotoxicity evaluations); upgraded per Feb. 27, 1995 EPA review with the submission of43501701. 

### 24870.3150

_ 42918642 is acceptable as per Feb. 28, 1994 EPA review and May 22, 1998 EPA review. 44262812 is acceptable as per May 22, 1998 EPA review. 

### 25870.3200

- Data are not required for nonfood uses. 

### 26870.3465

_ Data are not required; no data have been submitted to satisfy this data requirement.

27 

### 870.6100

- Data are not required; no data have been submitted to satisfy this data requirement.

28 

### 870.4100

- 42918648 is acceptable as per May 12, 1994 EPA review. 

### 29870.4100

- Data are no longer required for pesticide registrations (40 CFR 158). 

### 30870.4200

_ 42918648 is acceptable as per May 12, 1994 EPA review. 

### 31870.4200

- 42918649 is acceptable as per June 28, 1994 EPA review.

32 

### 870.7200

_ Data are not required for the registration of a technical product; data will be cited, as appropriate with the end-use product. 

### 33870.7600

_ Data cited are acceptable as per May 22, 1998 EPA review. 

### 34875.1100 -Ivirta is a member in good standing with the Ag Handlers Exposure Task Force. 

### 35875.1200 -Ivirta is a member in good standing with the Ag Handlers Exposure Task Force. 

### 36875.1300

- Ivirta is a member in good standing with the Ag Handlers Exposure Task Force. 

### 37875.1400 -Ivirta is a member in good standing with the Ag Handlers Exposure Task Force. 

### 38875.1500 -Ivirta is a member in good standing with the Ag Handlers Exposure Task Force. 

### 39875.1600 -Ivirta is a member in good standing with the Ag Handlers Exposure Task Force.

40 

### 875.2200

- Ivirta is a member in good standing with the Agricultural Re-entry Task Force and Outdoor Residential Exposure Task Force.

41 

### 875.2300

- Ivirta is a member in good standing with the Agricultural Re-entry Task Force and Outdoor Residential Exposure Task Force. 

### 42875.2400

- Ivirta is a member in good standing with the Agricultural Re-entry Task Force and Outdoor Residential Exposure Task Force.

43 

### 875.2500

- Ivirta is a member in good standing with the Agricultural Re-entry Task Force and Outdoor Residential Exposure Task Force.


### Page 20:3

### Endnotes for Data Matrix for MeW437 Technical

44835.2410

_ 42918662 is acceptable as per June 13, 1994 EPA review. 

### 45835.2370

_Data are not required; no data have been submitted to satisfy this data requirement. 

### 46835.6100

- 43291705 is acceptable as per Sept. 18, 1995 EPA review. 

### 47 835.6200

_ Data are not required based on limited uses (no aquatic uses proposed).

48 

### 835.6300

- Data are not required based on limited uses (no forestry uses proposed).
49 

### Ivirta is a member in good standing with the Spray Drift Task Force, Agricultural Re-entry Task Force, Agricultural Handlers Exposure Task Force, and the Outdoor Residential Exposure Task Force.



## Page 3 

## of]**... Decisions** 

**... '~**  **Data Requirements**  

# c, 

# e D: PeM"'g; 443301; 74054-5;570;CONDITIONA 

## !iii 75-DayLeiters 

## iii! 5: 885543 1111212010;Amendmen(' 74054



# - e D: Pending; 443057; 74054-5;400;NO DATA REi 

## !iii 75-DayLeiters 

## iii! (ALER7) 5: 887188 121712010; Mi's,eollan"0,1:,,,2, 

# -: e D: PeM"'g;442729; 74054-5;R340;NON-FA5T- 

## !iii 75-DayLeiters 

## iii! 5: 886718 121212010;Amendmen(' 74054 +,**.~** D: Closed; 408654; 74054-5;R330;NEWMANUi=\::"

# (.~**dt-Q~~** C"'" .r" "7**~'N"'**/)1' 

### S, 

# un c**~(ylLt~** 

## .../

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i ! !

### ! ; ! : " :**~~\** .

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# IIDecision Status Tracking Create ResubmissionRegulatory

### TYP~':'"**Ip~odu'ct' R~g~str,ati~'** **~**'Se,ct'ion 3 

# 3 Fee,ForService: 

### r' Yes'

# 'r.:fj,oj**4ppli6at~()hTY8~J~,~,~~dirl,ent,** 

# :3' Billable: {i- Yes 

### No
Company: f4054 jRVITAPLANT PROTECTIONN:V. 

# ·.::tj**J~egibtration Div'iSi~~.** **Rls~ M~~'a'gem,e~'Team**  10' Product#: 74054-5 

# IProduct Name:MCVV437 TECHNICAl..**MeT~d':':",',,,'r' ~C"--~"~~-~~~~~C;:**  Product Name:.

## I
Application Date:

Front End Dat": j29-NOV-201 0 }l3-DeC-201 0 FFS Due Dale: 

# I OPPTarget·Dote:**r··~ ~--~~**  

### f:wA

### Jnsti£:,"/"r

,**Rec'eiptDe's'c~iption:**

rmendmentrequiring data review 

# l . OPP Rec'vd Dote: p2-Dec-2010 RiskManager,Send Date,: 

# i
Negotiat"dDueDale:

# r Print Letter 

# I
Enter More Information ,. Tracking 

# r:

# 21-Day Screen ofAmendment (Completed by Contractor)

21-dayExpires on 1<.. 

# -7.. '3-10 

# DocumentPart Of: 7LfD:;:L/- S

# MRID, IfAny: 4**~ ~**  I 0 

# 'if



# Content Scree· ecommended to

86-5 Review: P, 

# ssed/ ailedINA

Document returned to:

I 

# ?M 10

# IFee for Servicel 

# » (8867180-

This package includes the following 

# I I for Division I '

### .-------------------~I 

# oNew Registration**~Amendment**



# ,**~** 

# Studies? D 

# Fee Waiver? I 

### I 

## J 

# OAD oBPPD**~RD**



## I D

# volpay % 

# Reduction:
_ Risk Mgr.
Receipt No. EPA File Symbol/Reg. No. Pin-Punch Date: 

# s-I 886718**~I==~** 

# _ 74054-5

1 

# 12/2/2010 

# D This item is NOT subject to FFS action. Action Code: Requested:

# IR~'-\.0 

# I
Granted: 

# I'\<-.

# ~4.o 

# I
Amount Due: 

# $ '3 i 

## loll

- I 

# Parent/Child Decisions:

<1£:.... I 

## I

# L

__**~_-------.--J ~--------------------~I**  

# ,Inert

# Cle~fd**f~_n ~>**  Uncleared Inert in Product ReViewer:

# ~~ Date: \::2--?>-(o 

## Remarks:

# PRIA2 - 21 DayContent ScreenReviewWorksheet (EPNOPPUse Only) 

### 3123/09 21 DayScreen StartDate: 

## /2.

- '2.

- I 0 / 

### Experts In-Processing Signature: /11 

### 1'= liI4ItA'.!J6 To;.l 

### Date 

## 12.

- 3· 10 

### Fee Paid: 

## Yes_V Divisionmanagement contacted on issues No Yes Date

______ _
EPAReg. Number: 

# 7L{

## 0

# S""

# '-I

- 

# s:- EPAReceiptDate: 

# J'L-l-/O

1

2



### 3 ItemsforReview ApplicationForm (EPAForm 8570-1)(link to 

### form) signed & 

### complete includingpackagetype

ConfidentialStatementofFormula all boxes completed, form signed, and dated Form

. a) All inerts (linkto http://www.epa.gov/opprdOOllinertsj), including fragrances, approved forthe proposed uses (see FootnoteA) Certification with Respect to Citation ofData (EPAForm form) completed and signed (N/A 

### if 100% repack) Certificate and datamatrix consistent
Ifapplicant is relying on data that are compensable, is the offer to pay statement included. (seeFootnote B)



### If is there a letter ofAuthorizationfor exclusive use yes

Exemption Statement (EPA Form 8570-27) (Link to form) no

4 

### completed and signed (NI 

### A ifsource is unregistered or applicant owns the



### 5 DataMatrix (EPAForm 8570-35) (Link to form) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A 

### if 100%

a) SelectiveMethod (Fee eX11ert., 

### use) b) Cite-All (Fee category experts use) c) Applicantowns all data (Fee category experts use) 

### Yes No 

## N/A*

5 CopiesofLabel (linktohttp://www.epa.gov/oppfeadl/labelingllrmD 6 (Electroniclabels on CD are encouraged and guidanceis available)( linkto 

# X http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#labels

1

### 7 

### Isthe datapackageconsistentwithPRNotice 86·5 (link to PRN 86-5) 

# ><
( 

### Notice ofFiling(link to 8 httU:llwww.eua.gov/uesticides/regulatin!!ltolerance uetitions.htm) included

# ~ with petitions (link to http://www.epa.gov/pesticides/regulating/tolerances.htm) 9 If

### applicablefor conventional applications,reducedrisk rationale (link to 

# X-- http://www.epa.gov/opprd001/workplanireducedrisk.html) RequiredData (link to 

# ;< httU:llwww.eua.gov/uesticides/regulatin!!ldata reguirements.htm) and/or datawaivers. See Footnote 

## C.

a) List study (or studies) not included with application

10

2

### Comments:



# *NI A - Not Applicable

Footnotes
A. During the 21 day initial contentreview, all CSFs will bereviewed to determine whether all inerts listed, includingfragrances, are approved for the proposed uses. Ifan unapproved inert is identified, the applicantmust either 1) resolvethe inert issueby, for example, removing the inert, substituting itwith an approved inert, submitting documentationthatEPA approved the inertfor theproposed pesticidal uses, correcting mistakes onthe CSF, etc. or2) provide the data to support OPP approval ofthe inert or 3) withdrawthe application. Removing or substituting an inert ingredient will require anew CSFand mayrequire submission ofdata. All information. forms, data and documentationresolving the inert issuemusthave beenreceivedbythe Agencyorthe application withdrawn withinthe 21 day period, otherwise, theAgency will reject the application as described below.
To successfullycomplete this aspect ofthe 21 day initial content screen, applicants are stronglyencouragedto verify that all inert ingredients havebeen approvedfor the application's uses even ifa productis currentlyregisteredbyconsulting the inertWeb 3

### site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and ifthe inertis not approved, to obtain the necessary inertapproval priorto sUbmittingan application to registera pesticideproductcontainingthatinertingredient. Someinert ingredients are no longer approvedfor food uses or certaintypes ofuses. The name and/orCAS numberon a CSFmustmatch the name and CAS numberonthis web site. Simpletypographical errors inthename or CAS numberhaveresulted in processing delays.
Ifan inert is not listed onthe inert ingredient web site and the applicantbelieves thatthe inerthas been approved,the applicant should contactthe Inert Ingredient Assessment Branch (IIAB) at inertsbranch@epa.gov andresolvethe issue. Copies ofthe correspondence with IIAB resolvingthe issue should accompany the application. All new inerts exceptPIP inerts arereviewedbyIIAB. The IIAB should also becontacted for any questions on what supporting data needs to be submittedfor and theAgency's inertreviewprocess. Questions onPIP inerts shouldbe directedto the Chiefof Microbial Pesticides Branch [Linkto http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm].
When a brand, trade, orproprietaryname ofaninert ingredient is listed on a CSF, additional information such as an alternate name ofthe inert, CAS number orother information [linkto http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included to enable theAgencyto determine ifit has been approved. Each component ofan inert mixture (including a fragrance) must beidentified. In some cases, the supplier ofthe mixture orfragrance may need to providethis informationto theAgency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplierto providethecomponent information to the Agency orpromptlyupon EPA's request. Ifthe inert ingredients in a proprietaryblend (includingfragrances) cannot orarenot identified orprovided within the 21-day contentreviewperiod, the Agency will reject the application. Duringthe 21 day content review, applicants should submit informationto the individual identified bytheAgency when the applicant is informed ofanunapproved inert. Unapproved InertsIdentified on CSFs
All applications except conventional new products andPIPs
Once anunapproved inert is identified on a CSF, the Agency will contactthe applicant with the following options:
1. Correct theapplicationby, for instance, correctingthe inert's identity orCAS number, providing documentationthatthe inerthas been approved, or removingtheunapproved inertfrom the CSF orreplacingit with onethat is approvedforthe application's uses; or 2. Submitthe information anddataneeded fortheAgencyto approvethe unapproved inert Ifthis option is selected and implemented,theAgency may request an extension in thePRIA decisionreview timeframeto accommodate the inertreview/approval process;
4

### 3. Withdrawthe application (theAgencyretains 25% ofthe full fee for thefee category estimated); or Ifnone ofthese options is selected and implementedbythe applicant withinthe 21 day contentreview period, theAgency will reject the application and retain 25% ofthe full fee ofthe category identified.
Conventional NewProductApplications
When the RegistrationDivision identifies anunapproved inert ona CSF with an applicationfor a newproductthatthe applicanthas not identified as requiring an inert approval (R311, R312 or R313), it will contactthe applicant with the following options:
1. Correct the applicationby, for instance, correcting the inert's identityorCAS number, providing documentationthat the inerthas been approved, or removing theunapproved inertfrom the CSFor replacing itwith onethat is approved for the application's uses; or 2. Submitthe informationand data needed for theAgencyto approvethe unapproved inert, including any required petition to establish oramend a tolerance orexemptionfrom a tolerance. (This optionmaychangethePRIA category for the application, which could require a longerdecision review time and a largerfee. Ifadditional fees aredue, they mustbereceivedbythe Agencywithinthe 21 day contentreviewperiod.)
3. Withdrawthe application (the Agencyretains 25% ofthefull fee for the fee category estimated); or

Ifnone ofthe above options is selected and implemented during the 21-day content-review period, theAgency will rejectthe application andretain 25% of the appropriate fee for thenew product-inert approval category.
PIPApplications
WhentheBiopesticide andPollutionPrevention Division identifies an unapproved inert on a PIP CSFand arequestto approvethe inert does not accompanythe application, it will contact the applicant withthefollowing options:
1. Correctthe application by, for instance, correctingthe spelling ornameofthe inertto that in40 CPR 174, orprovidingdocumentationthatthe inerthas been approved; or 2. Submitthe information and data needed for theAgency to approvethe unapproved inert. Ifan inertingredienttolerance exemptionpetition is required, thepetitionmustbereceived bytheAgency and the B903 fee paid withinthe 21 dayperiod. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 5

### 3. Withdrawthe 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 contentreview period, the Agency will reject the application and retain 25% of the fee.

B. A policy on documentation ofoffers to pay is still being developed, however, for a me-too orfast track (similar/identical)newproduct, R300 orA530, an application withoutthe necessary authorizations ofoffers to pay will beplaced into eitherR301 or A531. TheAgencyrecommends that authorizations ofoffers to paybe submittedwith otherPRlA applications to avoid delays intheAgency's decision.
C. 

### Biopesticide applicants are advised to contacttheAgency and discuss study waivers priorto submitting their application to the Agency. Documentation ofsuch discussions shouldbe submitted with the study waiver.

6