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 - Flumiclorac

Chemical # and Name: 128724

Flumiclorac

26-Aug-2010

GENERIC

ID # GDCI-128724-873

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)

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

835.4300

835.6100

835.6200

850.4225

850.5400

850.1300

850.1350

Aerobic aquatic metabolism

Terrestrial field dissipation

Aquatic field dissipation

Seedling emergence, Tier II

Algal toxicity, Tiers 1 and II

Daphnid chronic toxicity test

Mysid chronic toxicity test

N/A - Flumiclorac

Chemical # and Name: 128724

Flumiclorac

26-Aug-2010

GENERIC

ID # GDCI-128724-873

C,A,T,B

C,A,T,B

C,A,T,B

C,A,T,B

C,A,T,B

C,A,T,B

C,A,T,B

EP; PAI; TGAI

TEP

TEP

TEP

EP; PAI; TGAI

TGAI

TGAI

24

12

12

12

12

12

12

Page 1 of 

(1)

(3, 9)

(2, 8)

(5, 6, 13)

(4, 6, 14)

(12, 16)

(11, 17, 18)

N

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

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.2100

870.6200

870.7800

Avian acute oral toxicity test

Neurotoxicity screening battery

Immunotoxicity

N/A - Flumiclorac

Chemical # and Name: 128724

Flumiclorac

26-Aug-2010

GENERIC

ID # GDCI-128724-873

C,A,T,B

C,A,T,B

C,A,T,B

EP; PAI; TGAI

TGAI

TGAI

12

24

12

Page 2 of 

(7, 10, 15)

(19, 20, 21)

Y

N

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Flumiclorac

GDCI-128724-873

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

This study is needed to assess the degradation of flumiclorac-pentyl and the formation and degradation of its degradates, specifically the formation and degradation of 2-chloro-4-fluoro-5-

(3,4,5,6-tetrahydrophthalimido)phenoxyacetic acid (IMCA degradate) in the aquatic environment.

The complete aquatic field dissipation study is not necessary for flumiclorac-pentyl. Only the part of the study relevant to Footnote 7 in Title 40 CFR Part 158, the environmental chemistry method

for detecting parent flumiclorac-pentyl and the IMCA degradate in water is required.

Soil organic carbon partitioning data (Koc and Kd) are needed and must be included in the environmental chemistry method.

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

detrimental effects in the tier I testing.

Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed 

detrimental effects in the Tier I testing. In addition, evaluation of risk to Federally listed terrestrial plant species is based in part on the no observed adverse effect concentration (NOAEC) (or 

inhibition concentration which illicits a 5% effect (IC05)) for the most sensitive plant species tested, therefore an effect of less than 25% may not be sufficient to address risk to listed plants.

Required for known phytotoxicants such as herbicides, desiccants, and defoliants.

For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support enduse products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if 

there is no potential for environmental exposure.

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

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

Environmental chemistry methods must include results of a successful confirmatory method trial by an independent laboratory. However, the environmental chemistry method for detecting the 

parent and IMCA degradate in soil that was previously submitted (MRID 42825835) did not include the independent laboratory validation. The independent laboratory validation is now required. 

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

Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a 

highly volatile liquid, a highly reactive solid, or a highly corrosive material.

Data are required using the IMCA degradate.

Data are required using the IMCA degradate to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form 

of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.

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:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

T - Commercial, institutional and industrial premises

and equipment

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Flumiclorac

GDCI-128724-873

13

14

15

16

17

18

19

20

21

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

Data are required using the IMCA degradate (technical grade) with 10 species of terrestrial plants. The requirement is to use technical grade IMCA for this study instead of a TEP, and this 

approach is consistent with the Tier 1 Seedling Emergence study already conducted using IMCA (MRID 432580-01; Hoberg, 1994).

Data are required using the IMCA degradate (technical grade) for 3 species of non-vascular aquatic plants (blue-green algae and marine and freswhater diatoms). The requirement is to use 

technical grade IMCA for these studies instead of the TGAI (flumiclorac-pentyl) or a TEP, and this approach is consistent with the Tier I Algal Toxicity study already conducted using IMCA (MRID 

432408-01; Hoberg, 1994).

Data are required on one passerine species. EPA recommends submission of a passerine study protocol for review and approval prior to initiation of this study.

Data are required on one freshwater aquatic invertebrate species, Daphnia magna is preferred.

Data are required on one estuarine / marine invertebrate species, mysid shrimp is preferred.

Data are required on estuarine/marine species if the product meets any of the following conditions:

(i) intended for direct application to the estuarine or marine environment;

(ii) expected to enter this environment in significant concentrations because of its expected use or mobility patterns

(iii) if the acute LC50 or EC50 < 1 mg/l

(iv) if the estimated environmental concentration in water is equal to or greater than 0.01 of the acute EC50 or LC50 and any of the following conditions exist: 

 (a) studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected

 (b) physicochemical properties indicate bioaccumulation of the pesticide

 (c) the pesticide is persistent in water (e.g., half-life in water greater than 4 days).

As determined by the Agency, additional measurements may also be required, such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates. The route 

of exposure must correspond with the primary route of exposure.

All 90-day subchronic studies in rats can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity study using separate groups of animals for testing. Although the 

subchronic guidelines include the measurement of neurological endpoints, they do not meet the requirement of the 90-day neurotoxicity study (guideline 870.6200).

Acute and subchronic components of the neurotoxicity battery are required.

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 - Flumiclorac

Page: 1 of 1

59639 VALENT U.S.A. CORPORATION

Co. Nr. Company Name Agent For Company

1600 RIVIERA AVENUE, SUITE 200

Address City ZIP

WALNUT CREEK 94596

OMB Approval 2070-0174

State

CA

 DCI Number: GDCI-128724-873
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