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 Placement within the e-Jacket/jacket: 

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

o File location: (PDF page number, i.e., "before page 

45") 

2. /send to))9ta Extraction contractors this material: 

~ Newly stamped accepted label 

o /' Notification 

-g/ New CSF I al:r~-r.> ~ 

o Other: 

3. Attach this coversheet to the top oUhe material or jacket. It 

must be well organized and clipped together, NOT STAPLED. 

Then give the material with this coversheet to staff in the 

Information Services Center (Room 5-4900). 

Reviewer's Name: 6·A·~ 

Phone: 7·bo~ o6f~ Division: --=eb=-__ _ 

Date: ~±~/_~_l!r~--I_I--______________ ---

Created August 21, 2008 

_, _" _. , __ 0_. _,_._ru,_. ~ ___ ~_. _. _____ _ 

1
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 Jacket to File Room for Data Extraction for Registration: 74054-5, Decision: 

442729 

An action was just completed for Registration (74054-5), Decision (442729) that may require 

data extraction and I or imaging of a label for inclusion in the Pesticide Product Label System. 

Please return jacket (9283474) to the file room, and check it out to ISB"s data management contractor as 

soon as possible. 

If you have already returned this jacket, please accept our Thank you. 

This is an automatically generated notification message. Please do not reply to this address. 

2
3
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

April 21, 2011 

Irvital Plant Protection N.V. 

% Ann M. Tillman, Consultant 

Pyxis Regulatory Consulting, Inc. 

4110 136'h St. NW 

Gig Harbor, W A 98332 

Subject: Amendment - Add alternate CSF, and outdoor uses 

MCW 437 Technical (EPA Reg. No. 74054-5) 

Application dated November 29, 2010 

Dear Ms. Tillman: 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

The above referenced submission, in connection with registration under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable. 

Please note that we have approved the amended Confidential Statement of Formula (CSF) and 

labeling for the subject product with the understanding that they are consistent with the Agency's 

previously accepted CSF and labels, and that no other changes have been made. We have included 

copy of the newly accepted alternate CSF dated 02/03/11 in the record for the subject product. 

See enclosed copy of the stamped label for your record. If you have any questions concerning this 

action please contact Dr. B.A. Akinlosotu at (703) 605-0653. 

Sincerely, 

ichard Gebken, 

Product Manager 10 

Insecticide Branch 

Registration Division (7505P) 

Enclosure' Stamped accepted label 

4
ACTIVE INGREDIENT: 

MCW 437 TECHNICAL 

For Manufacturing Use Only 

Fiproni I: 5-amino-1-[2, 6-dichloro-4-(trifluoromethyl) phenyIJ-4-4-[ (1 R, S)-(trifluoromethyl)Sulfinyl) J1 H-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 or doctor immediately for treatment advice. 

swallowed: 0 Have person sip a glass of water if able 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 if possible. 

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

If in eyes: 0 Hold eye open and rinse slowly and gently with water for 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 doctor for treatment advice. 

If on skin or 0 Take off contaminated clothing. 

clothing: 0 Rinse skin immediately with plenty of water for 15-20 minutes. 

0 Call a poison control center or doctor for 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 

Under the Federal Insecticide Fungicide, 4515 Falls of Neuse Road, Suite 300 , h Raleigh NC 27609 and Rodenticide Act, as amended, for t e ' 

pesticide registered under: Net Weight: XXXX lb. 

EPA. Reg. No: 7Jf.o5JI-..-5 

MCW 437 Technical label 

5
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 contam inated clothing before reuse. 

ENVIRONMENTAL HAZARDS 

Do not discharge effiuent containing this product into lakes, streams, ponds, estuaries, 

ocean or other waters 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 of the 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, perimeter treatment 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 establishm ents (except for crack and crevice and bait station 

products) or in/or food/feed. 

Mew 437 Technical label 2 

6
STORAGE AND DISPOSAL 

Do not contam inate water, food, or feed 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 of this 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 if allowed by state and local authorities, Offer the drum for 

recycling, if available, 

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 of warranties and limitations of liability before using 

this product. If terms 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 of other materials, or the manner of use 

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 other warranties, express or implied, of merchantability or of fitness 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 or consequential damages resulting from the use or handling of this product, 

LIMITATIONS OF LIABILITY: To the extent consistent with applicable law, the exclusive remedy 

of the user or buyer for any and all losses, injuries or damages resulting from the use or handling 

of this product, whether in contract, warranty, tort, negligence, strict liability or otherwise, shall not 

exceed the purchase price paid or at Irvita Plant Protection, NV,'s election, the replacement of 

product. 

MCW 437 Technical label 3 

7
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 of the Manufacturing Use Product, MCW 437 Technical 

FROM: 

TO: 

Bruce F. Kitchens, Chemist 

Technical Review Branch/RD (7505P) 

Registration Division (7505P) 

RM #10, Richard Gebken/Bonaventure Akinlosotu 

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) 

for the registered manufacturing use product, MCW 437 Technical. This alternate formula is the result of 

the use of an 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 of this 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 of toxicological concern in this product. All impurities have a nominal concentration 

and an upper certified limit. 

3. The nominal concentrations of the 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. 

8
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 of the preliminary analysis. 

6. The alternate manufacturing site is listed below. Representative batches of MCW 437 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 of formation 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 

9

*Manufacturing process information may be entitled to confidential treatment*
DP BARCODE No.: 386395 

PC Codes: 129121 

NON-FOOD Use: 

FILE SYMBOL No.: 74054-5 

ACTION CODE: R340 

I Table 1. Manufacturin~ and Impuritz: Data for MeW 437 Technical 

DECISION No.: 442729 

I GLN II Reguirement II MRID II Status II Details and lor Deficiency 

830.1550 The NC of AI (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 of time, 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 of formation, quantification and 

830.1670 Discussion of formation of 483108-01 A identification of all 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. The AI & 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 for the 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 for the determination of the 

AI conieni in Ihe TGAI/MUP. 

A = Acceptable; N = unacceptable (see Deficiency); N/A = Not Applicable; G = Data gap; I = In progress or need upgrade; U 

= Up~Qrade (additional information required 

I 

I 

-

3 

10

*Manufacturing process information may be entitled to confidential treatment*
DP BARCODE No.: 386395 FILE SYMBOL No.: 74054-5 DECISION No.: 442729 

PC Codes: 129121 ACTION CODE: R340 

NON-FOOD Use: 

CONFIDENTIAL APPENDIX 

Results of the 5 batch analysis are provided in the following table: 

Table 1: Five batch analysis summary results 

Analyst Lab Active ingredient Total 1m purities 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 of the batches ranges between 99.2 to 99.7 % w/w (mean 99.4% w/w). 

1 Technical MCW 437. Determination of Active Ingredient and Impurities Present at or above 0.1% by 

HPLC. Analyst SOP 09.308.02. 

4 

11
c 

c 

« 

C') 

o 

-" <D 

LL 

12

*Confidential Statement of Formula may be entitled to confidential treatment*
Feb 03 11 03:02p Ann 6104585431 p.3 

13

*Confidential Statement of Formula may be entitled to confidential treatment*
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

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: 

I

f.,) 

ReVlew ' fd ' . f' f I" . hn' I 0 ata matnx III support 0 revJ,ew 0 a p IcatIg}1 to register new tec Ica 

product, me-too labeling (EPA 74054-/11 f 7 o5t\:.. . k: ~ \: . 0~~ C-h,~ /'/ -r 1'<) 

Nancy Andrews, Branch Chief }--\c'-.- 11 ~C ~ / /o/! / 

Edward Odenkirchen, Senior Science Ad".~y {)v . /' I: 

Stephen Wente, Biologist 5C;P/"7~~:? 101/;' 

Environmental Risk Branch I 

Environmental Fate and Effects Division (7507P) 

Office of Pesticide Programs 

Richard Gebkin, Risk Manager 

Bonaventure Akinlosotu, Risk Manager Reviewer 

Registration Division 

Office of Pesticide Programs (7505P) 

The Environmental Fate and Effects Division (EFED) was requested by the Registration 

Division to review a data matrix provided by Irvita Plant Inc. in support of its request to add 

residential outdoor uses (lawns, perimeter treatInents around buildings, and ornamental plants) to 

Irvita's "me too" registration ofMCW 437 Technical containing 96.50% fipronil. EFED cannot 

comment on the legal aspects of what is or is not compensable. However, EFED did identify the 

specific studies considered necessary (Section 4 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 of the residential outdoor uses does not change 

EFED's data requirements. Please see DP 377687, 379158 for the necessary infonnation. 

I 

14
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 9, 2011 

SUBJECT: Fipronil: Review of data matrix in support of review of application to register new 

source teclmical product and add outdoor use to teclmicallabel 

/' 

DP Barcode: 386695 

Registration N().: 74054- 5" 

PC Code: l291~~/ Decision No.: (142729 

Petition No.: ~ Regulatory Action: Product RegistrationSection 3 

Risk Assessment Type: NA 

TXRNo.:NA 

Case No.: NA 

CAS No.: NA 

MRIDNo.: NA 

FROM: 

TO: 

40 CFR:NA 

Jack 

Risk 

Arthur, 

Assessment 

Chief 

BZ~" d~ ,f 

~ 

Health Effects Division (7509 P) 

Richard Gebken, Risk Manager 

Bonaventure Akinlosotu, Risk Manager Reviewer 

Insecticide Branch 

Registration Division (7505P) 

v cr.Apr. 2010 

The Health Effects Division (HED) was requested by the Registration Division to review a data 

matrix provided by Irvirta Plant Inc. in support of its request for a registration ofMCW 437 

Technical containing 96.50% fipronil and being produced by a new source. The registrant, Irvita 

Plant Protection N.V., also indicated that the technical label has been revised to add outdoor 

uses. 

HED reviewed the health effects and human exposure study components of the data matrix 

submitted for registration ofMCW 437 technical grade fipronil from the previous source. The 

data matrix and teclmicallabel (including outdoor uses on lawns, perimeter treatment and 

ornamentals) for the new source ofMCW 437 is essentially the same as submitted in its previous 

submission. Therefore, the conclusions reached by HED in its data matrix review for the 

previous submission apply to this submission as well. If outdoor use is a new addition to the 

Page I of2 

15
label, this would not alter the conclusions reached by HED with regard to the data matrix. 

Outdoor residential uses require the same array of studies as the indoor uses that have continued 

to be listed on the technical label. 

Page 2 of2 

16
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 6, 2010 

MAKHTESHIM-AGAN OF NORTH AMERICA INC 

IRVITA PLANT PROTECTION N.V, 

4515 FALLS OF NEUSE RD STE 300 

RALEIGH, NC 27609-

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 02-DEC-1O, Our staff has completed a preliminary 

analysis of tbe material. The results are provided as follows: 

Your submittal was found to be in full compliance witb the standards for submission of 

data contained in PR Notice 86-5, A copy of your bibliography is enclosed, annotated witb 

Master Record ID's (MRIDs) assigned to each document submitted. Please use tbese numbers in 

all future references to tbese documents, Thank you for your cooperation. If you have any 

questions concerning tbis data submission, please raise tbem with the cognizant Product 

Manager, to whom the data have been released, 

17
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

December 3, 2010 

OPP Decision Number: D-442729 

EPA File Symbol or Registration Number: 74054-5 

Product Name: MCW 437 TECHNICAL 

EPA Receipt Date: 02-Dec-2010 

EPA Company Number: 74054 

Company Name: IRVITA PLANT PROTECTION N.V. 

Arm Stout 

MAKHTESHIM-AGAN OF NORTH AMERICA INC 

IRVITA PLANT PROTECTION N.V. 

4515 FALLS OF NEUSE RD STE 300 

RALEIGH, NC 27609-

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Amendment Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your amendment and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R340 

NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTIONARY LABEL 

STATEMENTS;SOURCE CHANGES TO AN UNREGISTERED SOURCE); 

No additional payment is due at this time. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely, ~ 

Fr~' taff -

/ InfO/ii IOn echn logy & Resources Management Division 

:/!/ 

18
MANA 

OVERNIGHT DELIVERY 

Richard Gebken (PM 10) 

Document Processing Desk (REGFEE) 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Room S-4900, One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202 

RE: Irvita Plant Protection N.V. 

November 29,2010 

MCW 437 Technical (EPA File Symbol 74054-5) 

Application for Amended Pesticide Registration 

PRIA Category R340 

Dear Mr. Gebken, 

483108..00 

On behalf of Irvita 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 of this application, we submit the following documents: 

1. Application for an Amended Pesticide Registration (EPA Form 8570-1) 

2. Confidential Statement of Formula (EPA Form 8570-4) for Alternate CSF #1 

3. Three (3) Copies of the Proposed Labeling 

4. A CD containing an electronic version of the proposed labeling 

5. Certification with Respect to Label Integrity 

6. Certification with Respect to Citation of Data (EPA Form 8570-34) 

7. Agency Internal Use Copy of the Data Matrix 

8. Public File Copy of the Data Matrix 

9. Copy ofPRIA payment 

10. Letter of Authorization 

II. Product Specific Data (3 copies of each 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 

Enforcement Analytical Method for MCW 437 Technical. Contains 

Confidential Business Information. 

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 Confidelllial Business Information. 

19
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 of Water and Solvent in Five Batches of 

Technical Fipronil. Contains Confidential Business l1iformation. 

Gorban, I. Fipronil Technical (MCW 437) Confirmation of Analyte 

Identification. Contains Confidential Business Information. 

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 of an Aqueous Dilution ofMCW 437 Technical. 

Walter, D. UVlVis Absorption Spectrum ofMCW 437 Technical. 

Walter, D. Melting Temperature ofMCW 437 Technical. 

Walter, D. Pour and Tap Density of MCW 437 Technical. 

Walter, D. Relative Density ofMCW 437 Technical. 

We would like to note that Irvita Plant Protection N.Y. is using the selective method of support. As per 

EPA's interpretations of 40 CFR Parts 152.86(b)(2)(i) and 152.93(b)(2)(i), Irvita Plant Protection N.V. 

submitted notices of intent 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) if you have any questions or need any additional information. 

Sincerely, 

Ann M. Tillman 

Enclosures 

20
Pt. ••• 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 if this 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 I and Section 11.) , , . , , 

This application falls under Category 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 Lilbollng accompanying 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 of individual ro btt contacted, if necfl3Sary, to procMs fhi$ application.) 

N'ame Title Telephone No. (Include Area Code) 

Pyxis Regulatory Consulting, Inc. Agent (253)-853-7369 

Certification 6. Dete Application 

I certify that tha statements I have made on this form and all attachments thereto- are true, accurata and completa. Received 

I acknowladga that any knowlingllv falsa or misleading statement may be punishable by fine or imprisorvnent 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 

.. 

21
Form Approved OM8 No. 2070-0060 

...... ft ..... · if 

UNITED STATES ENVIRONMENTM: PROTECTION AGENCY \~l 401 M Street, S.W . . -' WASHINGTON, D.C. 20460 

Paperwork ReductIon Act 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 for reregistration and specia' review activitles,;~ time .for reading the hstructions and ccm~eting the necessary forms. Send 

comments regarding burden estimate or any other aspect of thiS 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 not send the completed form to this address. 

Certification with Respect to Citation of Data 

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. NW Gig Hllrbor, WA 98332.253· 853--7369 74054·5 

Active InQredient(s) andlor reoresentative test comoound(s) Date 

F!pronil Nov. 29, 2010 

General Use Pattem(s) (list all those claimed for thIs 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: If your product is a 100% repackaging of another 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 list of companies sent offers of compensation (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 of support, and have included with this form [2] I am using the selective method of support (or cite·all option 

a list of companies sent offers of compensation (the Data Matrix form under the selective methOd). and have induded with this form a 

should be used for thIs purpose). completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO FAY 

(Required if using the dte·all method or when 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 of this application, to the extent required by FIFRA. 

SECTtON tit: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or this Data·Call·ln response is supported by all data submitted or cited in the 

application for registration, the form for reregistration, or the Data·Call·ln response. In addition, if the cite·all option or cite·all option under the selective method is 

indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an Identical or 

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and 

uses. 

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained 

'tile written permissIon of the original data submitter to cite that study. 

I certify that for each study cited in support of this registration or reregistration that is not an exctusive use study, either: (a) I am the original data 

submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all perlOdS of eligibilify 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) andlor 3(c)(2)(8) ofFIFRA; and (Ii) to commence negotiations to determine the 

amount and terms of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of aU offers to pay compensation and e,vidl1nce of their delivery in 

accordance with sections 3(c)(1)(F) andlor 3(c)(2)(8) of FIFRA are available and wtll be submitted to the Agency upon request Bh~'Jld I fail to produce such 

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registra\i,)O of my' 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 or misteadlng statement may be punIshable by fine or Imprisonment or 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 p er versions available. Su b mit onl y Pa pe r version. 

22
PYXIS REGULATORY CONSULTING, INC. 

4110136 St. NW 

Gig Harbor, WA 98332 

November 23, 2010 

VIA CERTIF!ED MAIL, RETIJRN RECEIPT REQUESTED 

70101060000250661681 

BASF Corpnration 

Agricultural Products 

PO Box 13528 

Research Triangle Park, NC 27709 

RE: Fipronil Offer-to-Pay 

To Whom It May Concern: 

Phone: 253-853-7369 

Fax: 253-853-5516 

www.PyxisRC.com 

Irvita Plant Protection N. V. (lrvita) is applying for an amended registration under the Federal Insecticide, Fungicide, 

and Rodenticide Act ("FlFRA"), 7 U.S.C. § 136 et seq., for its technical product called "MCW 437 Technical", 

containing fipronil as the active ingredient. 

Irvita's amendment uses the selective method of data support (40 C.F.R. §§ 152.90 - 152.96). For many guideline 

requirements, lrvita's application cites data previously submitted by BASF or relies 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. Attachment 2 lists the specific studies cited in Irvita's application. We hereby provide our notice 

of intent to apply and our offer to pay compensation to BASF, to the extent required by FIFRA § 3(c){l)(F), for the 

data cited in Irvita's amendment (see Attachments I and 2~ provided that BASF is identified by EPA as the "original 

data submitter" for such data. Further, we hereby offer to commence negoiations to determine the amount and terms 

of compensation, 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 

submitted to the EPA on or before the date that is 15 years before the date ofIrvita's application for amendment of 

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 of EPA's approval oflrvita's amendment are eligible for compensation 

If you are aware if any studies listed in Attachment 2 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. We reserve the right to revise this offer to pay upon receiving this information from you. 

If any of the studies listed in Attachment 2 do not satisfY the applicable data requirement and you have not submitted 

acceptable replacement study(ies), We request that you notifY us that a data gap exists. Unless we hear from you, we 

will understand that there are no outstanding data requirements and Irvita will not claim a data gap for any data 

requirements. Thank you very much for your cooperation. 

~ lanelle Kay 

Agent for Irvita Plant Protection N.V. 

cc: E. Gur; Makhteshim-Agan of North America, Inc. 

K. Venkatesh; Makhteshirn-Agan of North America, Inc. 

Attachments 

23
Attachment 1. Irvlta Plant Protection N.V. MeW 437 Technical Offer-to-Pay 

Guideline Number Guideline Title 

850.2300 (71-4(a)) Avian Reproductive Toxicity: Quail 

850.2300 (71-4(b)) Avian Reproductive Toxicity: 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 Dermal Toxicity 

870.6200 90-Dav Subchronic Neurotoxicity -Rat 

870.3700 (83-3) Prenatal Development Toxicity Studies 

870.3800 (83-4) Reproduction and Fertility Effects 

870.6300 (83-6) Developmental Neurotoxicity Study 

870.5100 (84-2(a)) Bacterial Reverse Mutation Test 

870.5300, 870.5375 (84-2(b)) In vitro Mammalian Cell Gene Mutation Test 

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 Contact Toxicity: 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) Anaerobic Aquatic Metabolism 

835.4400 (162-4) Aerobic Aquatic Metabolism 

835.1230,835.1240 (163-1) Leaching and Adsorption/Desorption 

835.1410 Volatility - Laboratory 

835.8100 Volatility - Field 

Page 1 

24
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 1 

25
Sarah Greubel 

From: 

Sent: 

To: 

Ann Tillman 

Tuesday, November 30, 2010 1 :29 PM 

Sarah Greubel 

Subject: FW: Pay.Gov Payment Confirmation -Irvita MCW 437 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 

26 treatment*

*Commercial/financial information may be entitled to confidential 
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 of these documents 

included with this submission. 

IPROPOSED LABEL 

Date Submitted 

EPA Registration # to EPA Electronic file name 

074054-5 November 29, 074054-5.201 01118.MCW 437 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 

Date 

27
January 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 of this 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 of Neuse Road, Suile 300, Raleigh, NC 27609, 

Should you have any other questions or comments, p!,:;ase do not hesitate to contact me, 

Sincerely, 

I rvila Plant Protection 

David Hebel 

General Manager 

28
Form 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 of this 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 MCW 437 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 

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 N V OWN 

830.1800 Enforcement Analytical 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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

29
Form 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 of this 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 Paqe 2.of 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection N.V. MCW 437 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 Waiver5 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

30
Form 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 of this 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 Paae3of20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection NY MCW 437 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 Required5 

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 M 35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

31
Form 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 or any other aspect of this 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 Gu ideline 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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

32
Form 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 of this 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::> of 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection NY MCW 437 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 endnote 7 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

33
Form 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 of this 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, Netherlands Antilles 

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 endnote 11 

42918674 OLD 

43279702 OLD 

850.1075 (72-1 (c),(d)) Fish Toxicity: Trout 42977902 OLD See end note 12 

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 Paper versions available. Submit only Paper version. Agency I nternal Use Copy 

34
Form 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 of this 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 of 20 

Applicanfs/Registranfs Name & Address Product 

Irvita Plant Protection NV MCW 437 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 

850.1010 (72-2(a)(b)) Freshwater Invertebrate Toxicity 42918625 OLD See endnote 13 

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 endnote 14 

850.1035 (72-3(c)) Estuarine/Marine Shrimp Toxicity 43279701 OLD See endnote 15 

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 Copy 

35
Form 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 of this 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) 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 

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 endnote 16 

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 endnote 17 

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 endnote 19 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

36
Form 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 of this 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 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 

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 required20 

organisms 

850.1735 Whole sediment: Acute Freshwater 45175901 BASF Corporation PAY 

Invertebrates 45878001 BASF Corporation PAY 

850.1740 Whole sediment: Acute Marine Invertebrates Not required21 

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 BAS F Corporation PAY 

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 Paper version. Agency Internal Use Copy 

37
Form 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 of this 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 Page l{)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 

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 required25 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

38
Form 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 of this 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 of 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection NV MCW 437 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 Paper version. Agency Internal Use Copy 

39
Form 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 of this 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 Page llof 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 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

40
Form 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 of this 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 Pagel30f 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection N.V. 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 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

41
Form 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 of this 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) Aerobic Aquatic 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 Paper version. Agency Internal Use Copy 

42
Form 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 of this 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('§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 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

43
Form 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 of this 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(oof 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 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 BAS F 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 Paper versions avallable. Submit only Paper version. Agency Internal Use Copy 

44
Form 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 of this 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 1 Paqel70f 20 

Applicant's/Registrant's Name & Address Product 

I rvita Plant Protection N V MCW 437 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 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, N V 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

45
Form 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 of this 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 Paqe Ii} 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 MRIO Number Submitter Status Note 

Cite-All under Selective Method utilized by I rvita 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 Paper Versions available. Submit only Paper version. Agency Internal Use Copy 

46
Form 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 of this 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 1 Page \'1of 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection NY MCW 437 Technical 

Pos Cabai Office Park Unit 13 

POB 403 Curacao, Netherlands Antilles 

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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

47
Form 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 of this 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)of 20 

Applicant's/Registrant's Name & Address Product 

Irvita Plant Protection NY MCW 437 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 Paper versions available. Submit only Paper version. Agency Internal Use Copy 

48
Endnotes for Data Matrix for MeW 437 Technical 

1 830.1650 _ These data are not required for the registration of a 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 refer to the Confidential Statement of Formula for MCW 437 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 or functional 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 MCW 437 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 per a 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 per Jan. 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~ 

49
Endnotes for Data Matrix for MeW 437 Technical 

17 850.1350 _ 43681201 is considered acceptable as per August 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 of 43501701. 

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 

50
Endnotes for Data Matrix for MeW 437 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] 

51
... Decisions ... 

'~ Data Requirements 

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

!iii 75-Day Leiters 

iii! 5: 885543 1111212010; Amendmen(' 74054 

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

!iii 75-Day Leiters 

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

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

!iii 75-Day Leiters 

iii! 5: 886718 121212010; Amendmen(' 74054 

+, .~ D: Closed; 408654; 74054-5;R330;NEW MANUi=\::" 

(.~ dt-Q~~ C"'" .r" 

"7 ~'N"' /)1' S, un c 

~(ylLt~ .../ 

" ': 

') 

i ! ! ! ; ! 

: 

" 

: ~~\ . 

/f II 

52
Decision Status 

Tracking 

Create Resubmission 

53
Regulatory TYP~':'" Ip~odu'ct' R~g~str,ati~' ~ 'Se,ct'ion 3 3 Fee,For Service: 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 I Product 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: 

rmendment requiring 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 : 

54
21-Day Screen of Amendment 

(Completed by Contractor) 

21-day Expires on 1<.. -7.. '3-10 

Document Part Of: 7LfD:;:L/- SMRID, If Any: 4 ~ ~ I 0 'if 

Content Scree· ecommended to 

86-5 Review: P, ssed/ ailedINA 

Document returned to: 

I 

?M 10 

55
IFee for Servicel 

» 

(8867180-

This package includes the following I I for Division 

I ' 

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

o New 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: 

56
PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPNOPP Use Only) 

3123/09 

21 Day Screen Start Date: /2. - '2. - I 0 / 

Experts In-Processing Signature: /11 1'= liI4ItA'.!J6 To;.l Date 12. - 3· 10 Fee Paid: Yes_V 

Division management contacted on issues No Yes Date ______ _ 

EPA Reg. Number: 7 L{ 0 S"" '-I - s:- EPA Receipt Date: J'L-l-/O 

1 

2 

3 

Items for Review 

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

including package type 

Confidential Statement of Formula all boxes completed, form signed, and 

dated Form . 

a) All inerts (link to http://www.epa.gov/opprdOOllinertsj), 

including fragrances, approved for the proposed uses (see 

Footnote A) 

Certification with Respect to Citation of Data (EPA Form 

form) completed and signed (N/A if 100% repack) 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

If is there a letter of Authorization for exclusive use 

yes 

Exemption Statement (EPA Form 8570-27) (Link to form) 

no 

4 completed and signed (NI A if source is unregistered or applicant owns the 

5 

Data Matrix (EPA Form 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) Selective Method (Fee eX11ert., use) 

b) Cite-All (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

Yes No N/A* 

5 Copies of Label (link to http://www.epa.gov/oppfeadl/labelingllrmD 

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

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

1 

57
7 Is the data package consistent with PR Notice 86·5 (link to PRN 86-5) 

( >< 

Notice of Filing (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 applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprd001/workplanireducedrisk.html) X--

Required Data (link to ;< httU:llwww.eua.gov/uesticides/regulatin!!ldata reguirements.htm) and/or 

data waivers. See Footnote C. 

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

10 

2 

58
Comments: 

* NI A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All information. forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise, the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 

59
site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to sUbmitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (IIAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

correspondence with IIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by IIAB. The IIAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm ]. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 

60
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CPR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

61
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRlA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

62