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 - Tebufenozide

Chemical # and Name: 129026

Tebufenozide

09-Jul-2010

GENERIC

ID # GDCI-129026-872

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 _________________________________________________________________

 

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Product Chemistry Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

830.7050

850.1500

850.3040

Terrestrial Plant Toxicity (Seedling Emergence)

Terrestrial plant toxicity, Tier 1 (vegetative vigor)

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

UV/Visible absorption

Fish life cycle toxicity

Field testing for pollinators

N/A - Tebufenozide

Chemical # and Name: 129026

Tebufenozide

09-Jul-2010

GENERIC

ID # GDCI-129026-872

J,C,A

J,C,A

J,C,A

J,C,A

J,C,A

J,C,A

TEP

TEP

TEP or TGAI

TGAI/PAI

TGAI

TEP

12

12

12

8

24

24

Page 1 of 

(7, 9, 10)

(7, 8, 9, 12)

(1, 2, 9, 10)

(3, 5, 11)

(4, 6)

N

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

 

Toxicology Data Requirements (Conventional Chemical)

870.7800 Immunotoxicity

N/A - Tebufenozide

Chemical # and Name: 129026

Tebufenozide

09-Jul-2010

GENERIC

ID # GDCI-129026-872

J,C,A TGAI 12

Page 2 of 

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Tebufenozide

GDCI-129026-872

1

2

3

4

5

6

7

8

9

10

11

12

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

Tier II required if the tested species exhibits a 50 percent or greater detrimental effect in Tier 1 study. When Tier II testing is required, the test species should be the species that showed 

detrimental effects in the Tier I testing.

Tier I not required for known phytotoxicants.

This study must include observations of secondary sexual characteristics, vitellogenin measurements, and an evaluation of gonadel histopathology.

The honeybee (Apis mellifera)is the required test species.

The freshwater fish (fathead minnow) is the required test species.

Required if any of the following conditions are met: (i) data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse 

effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.); (ii) data from residual toxicity studies indicate extended residual toxicity; (iii) data derived from 

studies with arthropods other than bees that indicate potential chronic, reproductive, or behavioral effects.

Not required for known phytotoxicants.

Not required for for aquatic residential uses.

Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.

Not required for aquatic residential uses.

Given the existing fish chronic toxicity data for tebufenozide, EPA has approved the use of OECD Guideline 219, fish short-term reproduction assay, to address specific uncertainties identified 

in the previous fish chronic toxicity studies. The use of OECD Guideline 219 test in this specific case does not constitute a precedent where this study design can be regularly used in lieu of 

EPA Guideline 850.1500.

Generally not required for granular formulations. May be requested on a case-by-case basis.

Case # and Name:

DCI Number:

Page: 1 of 1

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:

A - Terrestrial food crop

C - Terrestrial nonfood crop

J - Forestry use
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Tebufenozide

Page: 1 of 1

8033 NIPPON SODA CO., LTD.

Co. Nr. Company Name Agent For Company

NISSO AMERICA INC 88 PINE STREET, 14TH FLOOR

Address City ZIP

NEW YORK 10005 

OMB Approval 2070-0174

State

NY

 DCI Number: GDCI-129026-872
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