Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. 

Use additional sheet(s) if necessary.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

6b. I agree to satisfy Generic Data

Requirements as indicated on the 

attached form entitled 

"Requirements Status and 

Registrant's Response."

7a. My product is an MUP and I 

agree to satisfy the MUP 

requirement on the attached form

entitled "Requirements Status and

Registrant's Response."

7b. My product is an EUP and I 

agree to satisfy the EUP 

requirement on the attached form 

entitled "Requirements Status and 

Registrant's Response."

OMB Approval 2070-0174

1. Company Name and Address

 

N/A - Trinexapac-ethyl

Chemical # and Name: 112602

Trinexapac-ethyl

11-Mar-2010

GENERIC

ID # GDCI-112602-880

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page of 1 1

8. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

12. Name of Company

11. Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

 

Environmental Fate Data Requirements (Conventional 

Chemical)

Product Chemistry Data Requirements (Conventional 

Chemical)

Residue Chemistry Data Requirements for Food Uses 

(Conventional Chemical)

835.6100

830.7050

860.1340

860.1500

860.1500

Terrestrial field dissipation

UV/Visible absorption

Residue analytical method

Crop field trials (GRASS, HAY) 

Crop field trials (GRASS, FORAGE) 

N/A - Trinexapac-ethyl

Chemical # and Name: 112602

Trinexapac-ethyl

11-Mar-2010

GENERIC

ID # GDCI-112602-880

HH,II,Q

HH,II,Q

HH,II,Q

HH,II,Q

HH,II,Q

TEP

TGAI/PAI

Residue of Concern

TEP

TEP

24

8

24

24

24

Page 1 of 

(11)

(10)

(5, 6, 15, 17, 

19)

(3, 8, 12)

(4, 6, 7, 9, 

15)

N

N

N

N

N

2
Date

OMB Approval 2070-0174

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

 

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.2100

870.6200

880.3550

Avian acute oral toxicity test

Neurotoxicity screening battery

Immunotoxicity

N/A - Trinexapac-ethyl

Chemical # and Name: 112602

Trinexapac-ethyl

11-Mar-2010

GENERIC

ID # GDCI-112602-880

HH,II,Q

HH,II,Q

HH,II,Q

TGAI, TEP

TGAI

12

24

0

Page 2 of 

(13, 16, 18)

(1, 2, 14)

N

N

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Trinexapac-ethyl

GDCI-112602-880

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

This study must assess both acute and subchronic parameters to evaluate the potential of a repeated chemical exposure to produce adverse effects on the nervous system.

The timeframe for completing the acute neurotoxicty screening study is 12 months.

The registrant must revise the existing method to include an enzymatic and/or mild acid hydrolysis step to release conjugated residues of this chemical.

Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a 

statistical design accepted by the Agency.

Required if indoor use could result in pesticide residues in or on food or feed.

Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.

Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).

New analytical methods to be used for enforcement puposes must include results from an independent laboratory validation.

For a national registration, the draft guidance document recommends that a total of 8 field trials be performed on representative varieties (specifically, 3 trials in EPA Growing Zone 12, 2 trials in 

Zone 11, and 3 trials in Zone 5). For a regional Pacific Northwest registration (growing regions 11 and 12), the draft guidance document recommends that a total of 5 field trials be performed on

representative varieties (specifically, 3 trials in EPA Growing Zone 12 and 2 trials in Zone 11).

Environmental chemistry used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and 

procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.

Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. The 

environmental chemistry methods must include a statement of no data confidentiality claims, i.e., non-CBI. Test standards and procedures for independent laboratory validation are available as 

addenda to the guideline for this test requirement.

Data on residue analytical methods arre required for both plants and livestock commodities.

Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are 

preferred on waterfowl or upland game bird species for indoor and greenhouse uses.

Additional measurements such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates, will also be required. The route of exposure must correspond 

with the primary route of exposure.

A residue method, storage stability data, and crop field trials are required for the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues found on the green 

tobacco, additional data may be required on cured/dried tobacco and pyrolysis products (guideline 860.1000).

Case # and Name:

DCI Number:

Page: 1 of

Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. 

These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement.

Use Categories Key:

Q - Residential outdoor use

HH - Occupational Use Conventional Chemical

II - Residential Use Conventional Chemical

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Trinexapac-ethyl

GDCI-112602-880

16

17

18

19

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

A passerine study protocol must be submitted for review by the Agency prior to initiation of this study.

 New analytical methods to be used for enforcement purposes must include results from an independent laboratory validation.

 Data using the TEP are conditionally required based on the results of the avian acute oral (TGAI) and avian subacute dietary tests, intended use pattern, and pertinent environmental fate 

characteristics that indicate potential exposure.

 A residue analytical method suitable for enforcement purposes is required whenever a numeric tolerance (including temporary and time-limited tolerance) is proposed, and may be required for a

tolerance exemption.

Case # and Name:

DCI Number:

Page: 2 of 2
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Trinexapac-ethyl

Page: 1 of 1

83558

35935

100

CELSIUS PROPERTY B.V., AMSTERDAM 

(NL) 

NUFARM LIMITED

SYNGENTA CROP PROTECTION, LLC

Co. Nr. Company Name Agent For Company

MAKHTESHIM AGAN OF NORTH 

AMERICA, INC.

NUFARM LIMITED

3120 HIGHWOODS BLVD., SUITE 100

4020 AERIAL CENTER PKWY., STE 103

410 SWING ROAD, P.O. Box 18300

Address City ZIP

RALEIGH

MORRISVILLE

GREENSBORO

27604 

27560 

274198300

OMB Approval 2070-0174

State

NC

NC

NC

 DCI Number: GDCI-112602-880
LINKS TO FORMS:

The pesticide registration forms that are listed below can be found at:

http://www.epa.gov/opprd001/forms/

Link to Confidential Statement of Formula and Instructions (Form # 8570-4)

http://www.epa.gov/opprd001/forms/8570-4.pdf

Certification of Attempt to Enter Into an Agreement With Registrants for 

Development of Data (Form # 8570-32)

http://www.epa.gov/opprd001/forms/8570-32.pdf

Certification With Respect to Citation of Data (Form # 8570-34)

http://www.epa.gov/opprd001/forms/8570-34.pdf