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

 

0245 - Fenbutatin-oxide

Chemical # and Name: 104601

Fenbutatin-oxide

15-Apr-2011

GENERIC

ID # GDCI-104601-834

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

835.4400

850.4100

850.4150

850.4400

850.5400

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Terrestrial Plant Toxicity (Seedling Emergence)

Terrestrial plant toxicity, Tier 1 (vegetative vigor)

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Algal toxicity, Tiers 1 and II

0245 - Fenbutatin-oxide

Chemical # and Name: 104601

Fenbutatin-oxide

15-Apr-2011

GENERIC

ID # GDCI-104601-834

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

EP; PAI; TGAI

EP; PAI; TGAI

TEP

TEP

EP; PAI; TGAI

EP; PAI; TGAI

24

24

12

12

12

12

Page 1 of 

(6, 11, 23)

(5, 11, 23)

(14, 23)

(13, 24)

Y

Y

N

N

N

N

3
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)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical),Environmental Fate 

Data Requirements (Conventional Chemical)

850.1010

850.1075

850.1350

850.1400

850.2100

850.1730

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Fish acute toxicity test, freshwater and marine

Mysid chronic toxicity test

Fish early-life stage toxicity test

Avian acute oral toxicity test

Fish BCF

0245 - Fenbutatin-oxide

Chemical # and Name: 104601

Fenbutatin-oxide

15-Apr-2011

GENERIC

ID # GDCI-104601-834

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

EP; PAI; TGAI

EP; PAI; TGAI

TGAI

TGAI

EP; PAI; TGAI

EP; PAI; TGAI

12

12

12

12

12

12

Page 2 of 

(10)

(8, 10)

(17)

(15, 18)

(12, 16)

N

N

N

N

Y

N

3
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)

870.3465

870.6200

870.7600

8501735S

8501740S

870.7800

90-day inhalation toxicity

Neurotoxicity screening battery

Dermal penetration

Whole Sediment Chronic Tox (Freshwater)

Whole Sediment Chronic Tox (Estuarine)

Immunotoxicity

0245 - Fenbutatin-oxide

Chemical # and Name: 104601

Fenbutatin-oxide

15-Apr-2011

GENERIC

ID # GDCI-104601-834

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

U,S,A,O,K,R,C,B,Q

TGAI

TGAI

CHOICE

EP; PAI; TGAI

EP; PAI; TGAI

TGAI

12

24

12

12

12

12

Page 3 of 

(20)

(21)

(1, 2, 3, 9, 

19, 22)

(1, 4, 7, 9, 

19, 22)

N

Y

N

Y

Y

Y

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

0245 - Fenbutatin-oxide

GDCI-104601-834

1

2

3

4

5

6

7

8

9

10

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 preferred sediment is formulated; guidance for the formulated sediment can be found in OECD 218 Sediment-Water Chironomid Toxicity Test using Spiked Sediment.

Test Method 100.5: Life-cycle Test for Measuring the Effects of Sediment-associated Contaminants on Chironomus dilutus (formerly known as C. tentans) in USEPA 2000 Methods for Measuring

the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invertebrates EPA 6001R-99/064

Required in order to fulfill the data requirements and reduce the uncertainties associated with a lack of sediment toxicity data, 28-day spiked sediment studies (with suitable range finding tests) 

should be completed with fenbutatin-oxide per OPPTS Guidelines 850.1735 for sediment dwelling freshwater.

Required in order to fulfill the data requirements and reduce the uncertainties associated with a lack of sediment toxicity data, 28-day spiked sediment studies (with suitable range finding tests) 

should be completed with fenbutatin-oxide per OPPTS Guideline 850.1740 for sediment dwelling estuarine/marine invertebrates.

Refer to public draft guideline 850.4250 for guidance on Tier II vegetative vigor testing.

Refer to public draft guideline 850.4225 for guidance on Tier II seedling emergence testing.

Leptocheirus plumulosus in USEPA 2001 Method for Assessing the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants with the Amphipod Leptocheirus plumulosus EPA

6001R-0l/020

Freshwater fish LC50 (use most sensitive of the species tested), and acute LC50/EC50 estuarine and marine organisms.

For alternative test designs, the protocol should discuss the power of the test.

Data are required on flow through systems. Currently available data on static systems are not adequate to fulfill the guideline.

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

K - Residential

O - Residential Indoor use

Q - Residential outdoor use

R - Agricultural premises and equipment

S - Food handling/storage establishments premises

and equipment

U - Residential and public access premises

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

0245 - Fenbutatin-oxide

GDCI-104601-834

11

12

13

14

15

16

17

18

19

20

21

22

23

24

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 for six species of dicots from at least four families, one species of which is soybean (Glycine max). Data are required for four species of monocots from at least two families,

one species which is corn (Zea mays). At least one of either the monocot or dicot species must be a root crop.

Data are required for passerine bird species. A protocol must be submitted prior to initiation of this study.

Data are required for a freshwater green alga species, a freshwater diatom species, a marine diatom species, and a cyanobacterium (formerly known as blue-green algae).

Data are required for a duckweed species.

Data are preferred on sheepshead minnow (Cypinodon variegatus).

Data are preferred on redwing blackbird (Agelaius phoneiceus).

Data are preferred on mysid shrimp (Americamysis bahia).

Data are needed on estuarine/marine fish only.

Based on test variability for the endpoint of concern and the need to establish a NOAEC/LOAEC the following number of replicates and test animals are recommended: for the midge test with C. 

dilutus 16 replicates containing 12 test organisms each (12 replicates at test initiation; 4 added at 10 days for auxillary males); for the freshwater amphipod H. azteca test of 12 replicates per 

treatment (4 for 28-d survival and growth and 8 for the remainder of the test) with 10 neonates per replicate; and for the L. plumulosus 10 replicates per treatment with 20 neonates per 

replicate.

Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21 or 28-days, may be sufficient to satisfy this requirement. Registrants should consult 

with the Agency to determine whether studies of shorter duration would meet this requirement.

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 protocol should be submitted for approval prior to testing.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC25 

(concentration at which there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that Fenbutatin oxide "may affect" and is ¿likely to adversely affect¿ listed plant

species.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC25 

(concentration at which there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that Fenbutatin oxide "may affect" and is "likely to adversely affect" listed plant 

species.

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: 0245 - Fenbutatin-oxide

Page: 1 of 1

70506 UNITED PHOSPHORUS, INC

Co. Nr. Company Name Agent For Company

630 FREEDOM BUSINESS CENTER, SUITE 402

Address City ZIP

KING OF PRUSSIA 19406 

OMB Approval 2070-0174

State

PA

 DCI Number: GDCI-104601-834
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