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 - Fluazinam

Chemical # and Name: 129098

Fluazinam

12-Aug-2011

GENERIC

ID # GDCI-129098-875

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)

835.6100

835.6200

850.4225

850.4400

850.5400

850.1350

Terrestrial field dissipation

Aquatic field dissipation

Seedling emergence, Tier II

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Algal toxicity, Tiers 1 and II

Mysid chronic toxicity test

N/A - Fluazinam

Chemical # and Name: 129098

Fluazinam

12-Aug-2011

GENERIC

ID # GDCI-129098-875

A

A

A

A

A

A

TEP

TEP

TEP

EP; PAI; TGAI

EP; PAI; TGAI

TGAI

12

12

12

12

12

12

Page 1 of 

(22)

(21)

(5, 7, 8, 9, 

26)

(4, 7)

(6, 7, 8)

(14, 16, 19, 

24)

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)

850.1400

850.2100

870.3465

870.7800

850.1790

Fish early-life stage toxicity test

Avian acute oral toxicity test

90-day inhalation toxicity

Immunotoxicity

Chironomid Sediment Toxicity Test

N/A - Fluazinam

Chemical # and Name: 129098

Fluazinam

12-Aug-2011

GENERIC

ID # GDCI-129098-875

A

A

A

A

A

TGAI

EP; PAI; TGAI

TGAI

TGAI

EP; PAI; TGAI

12

12

24

12

12

Page 2 of 

(13, 15, 18)

(10, 11, 12, 

23)

(3, 20)

(1, 2, 17, 25)

N

Y

N

N

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluazinam

GDCI-129098-875

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

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

The test substance should be the technical grade active ingredient.

Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estaurine or marine environment or the product is expected to enter this 

environment in concentrations which the Agency believes to be significant, either by runoff or erosion, because of its expected use or mobility pattern.

Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.

Required if an aquatic species exhibits a 50 percent or greater detrimental effect in Tier 1.

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

Not required for known phytotoxicants.

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.

Generally not required for granular formulations, but may be required on a case-by-case basis.

For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing use products to be reformulated or to support these same end-use products when 

there is no registered manufacturing use product. For 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.

Data using the TGAI are required to support all outdoor end-use product uses including 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 on one passerine species.

Data are required on one estaurine/marine species, preferably the sheepshead minnow (Cypinodon variegatus).

Data are required on one estaurine/marine invertebrate species.

Data are required on marine species if the product is: (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, and (iii) if the acute LC50 or EC50 < 1 mg/l; or (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).

Data are required on estuarine species if the product is: (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, and (iii) if the acute LC50 or EC50 < 1 mg/l; or (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).

Data are required if:

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

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluazinam

GDCI-129098-875

18

19

20

21

22

23

24

25

26

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

i. The estimated environmental concentration (EEC) in sediment is>0.1 of the acute LC50/EC50values and

ii. The half-life of the pesticide in the sediment is>10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:

A. The soil partition coefficient (Kd) is¿50.

B. The log Kow is¿3.

C. The Koc¿1,000.

iii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.

Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticides residues from the proposed use(s) can enter waterways.

Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.

Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, a 28-day study would be sufficient to satisfy this requirement.

An environmental chemistry method and associated independent laboratory validation for fluazinam residues of concern in water and sediment are required. An entire aquatic field dissipation 

study is not required.

An environmental chemistry method and associated independent laboratory validation for fluazinam residues of concern in soil are required. An entire field dissipation study is not required.

A protocol will need to be provided to EPA for review prior to starting toxicity testing.

A chronic study submitted for estuarine/marine aquatic invertebrates in response to the RED DCI was classified as supplemental. This chronic mysid study may be upgraded from supplemental 

if additional raw data are provided.

A chironomid study submitted to the Agency has been classified as supplemental. This study may be upgraded from supplemental if additional raw data is provided.

A Tier I study may be conducted initially. However, Tier II testing is required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When a Tier II 

testing is conducted, the test species should be the species that showed detrimental efects in the Tier I testing.

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 - Fluazinam

Page: 1 of 1

71512 ISK BIOSCIENCES CORPORATION

Co. Nr. Company Name Agent For Company

7470 AUBURN ROAD, SUITE A

Address City ZIP

CONCORD 44077

OMB Approval 2070-0174

State

OH

 DCI Number: GDCI-129098-875
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