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 - Esfenvalerate

Chemical # and Name: 109303

Esfenvalerate

12-May-2011

GENERIC

ID # GDCI-109303-828

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

N/A - Esfenvalerate

Chemical # and Name: 109303

Esfenvalerate

12-May-2011

GENERIC

ID # GDCI-109303-828

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

TGAI or PAIRA

TGAI or PAIRA

TEP

TEP

EP; PAI; TGAI

TEP or TGAI

24

24

12

12

12

12

Page 1 of 

(9, 17, 30)

(8, 17, 30)

(19, 29)

(18, 29)

N

N

N

N

N

N

4
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)

850.1010

850.1025

850.1075

850.1350

850.1500

850.2100

850.2300

870.3465

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Oyster acute toxicity test (shell deposition)

Fish acute toxicity test, freshwater and marine

Mysid chronic toxicity test

Fish life cycle toxicity

Avian acute oral toxicity test

Avian reproduction test

90-day inhalation toxicity

N/A - Esfenvalerate

Chemical # and Name: 109303

Esfenvalerate

12-May-2011

GENERIC

ID # GDCI-109303-828

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

EP; PAI; TGAI

TGAI, TEP

EP; PAI; TGAI

TGAI

TGAI

TGAI, TEP

TGAI

TGAI

12

12

12

12

24

18

24

24

Page 2 of 

(25)

(26)

(13, 15)

(24)

(14)

(23, 27)

(6, 22)

(1)

N

N

N

N

N

Y

N

N

4
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)

870.6300

870.7800

835.6200

860.1500

860.1500

860.1500

860.1500

SS-1065

Developmental neurotoxicity study

Immunotoxicity

Aquatic field dissipation

Crop field trials (PEA, FIELD, HAY) 

Crop field trials (COTTON, GIN BYPRODUCTS) 

Crop field trials (PEA, FIELD, VINES) 

Crop field trials (SOYBEAN, SEED) 

POTW Treatability Study

N/A - Esfenvalerate

Chemical # and Name: 109303

Esfenvalerate

12-May-2011

GENERIC

ID # GDCI-109303-828

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

A,O,Q

TGAI

TGAI

TEP

TEP

48

12

12

24

24

24

24

24

Page 3 of 

(16)

(11)

(5, 12)

(7)

(7)

(7)

(20)

(11, 28)

N

Y

N

N

N

N

N

Y

4
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

SS-1066

SS-1069

SS-1072

Chronic Sediment - Hyalella Azteca

Chronic Sediment - Chironomus dilutus

Chronic Sediment - Leptocheirus plumulosus

N/A - Esfenvalerate

Chemical # and Name: 109303

Esfenvalerate

12-May-2011

GENERIC

ID # GDCI-109303-828

A,O,Q

A,O,Q

A,O,Q

24

24

24

Page 4 of 

(3, 10, 21)

(2, 10, 21)

(4, 10, 21)

Y

Y

Y

4
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Esfenvalerate

GDCI-109303-828

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

While the inhalation guideline calls for a 90-day study duration, a 28-day study duration will satisfy the Agency's short-and intermediate-term inhalation exposure data needs for this chemical 

based on current use patterns.

Use 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 600/R-99/064.

Use test Method 100.4: Hyalella azteca 42-d Test for Measuring the Effects of Sediment-associated Contaminants on Survival, Growth, and Reproduction in USEPA 2000 Methods for Measuring 

the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invertebrates EPA 600/R-99/064.

Use USEPA 2001 Method for Assessing the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants with the Amphipod Leptocheirus plumulosus EPA 600/R-0l/020.

The complete aquatic field dissipation study is not required at this time. Only the environmental chemistry methods in sediment and independent laboratory validation are required.

The Agency recently received an avian reproduction study (MRID 48027802) conducted with esfenvalerate, and these data are in review. If acceptable, the Agency will consider whether they 

can be used to satisfy this requirement.

Test substance for crop field trials is a typical end-use product.

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.

Protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.

Protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.

MRIDs 47053001 and 47053002 were previously submitted to the Agency to fulfill this data requirement. However, the submitted method report and independent laboratory validation (ILV) 

report contain the same validation data. The submission is incomplete because EPA is missing the original environmental chemistry analytical method for sediment. Registrants must either submit

an entirely new environmental chemistry method and independent laboratory validation OR submit the original method report that indicates the laboratory, study director, and original validation 

results that are independent of the laboratory, study director, and validation results indicated in the submitted ILV.

Freshwater fish toxicity tests are required for one coldwater and one warmwater species to be conducted with TGAI. The test species should also have acceptable TEP data available (i.e. 

rainbow trout and bluegill sunfish).

Fish full life cycle studies are required for both a freshwater species and an estuarine/marine species. Studies are to be conducted with species for which the Agency has acceptable acute 

data.

Estuarine/marine fish toxicity test is required for one species using the TGAI and TEP. The TEP study must examine toxicity to the most sensitive species tested with the TGAI.

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

O - Residential Indoor use

Q - Residential outdoor use

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Esfenvalerate

GDCI-109303-828

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

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

EPA has recently determined that, as an alternative to the generation and submission of a new DNT study, pyrethroid registrants may instead choose to cite previously submitted DNT studies for

pyrethroid pesticides. The Agency is also investigating the need for additional experimentation, specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evaluate the 

potential for increased susceptibility of young organisms. For more information on the pyrethroid developmental neurotoxicity (DNT) requirement, see 

http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

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 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.

Crop field trials are required for soybean aspirated grain fractions.

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.

Avian reproduction studies are required for for an upland game bird and waterfowl to be conducted with TGAI.

Avian acute oral toxicity data required for TGAI only. Avian acute oral toxicity data for the passerine species conducted with TEP are not required.

Aquatic invertebrate life-cycle required for one saltwater species to be conducted with TGAI.

Aquatic invertebrate acute toxicity data for a TEP are required for test species Daphnia magna, and aquatic invertebrate acute toxicity data for the TGAI are required for test species Hyalella 

azteca.

Acute toxicity to estuarine/marine invertebrate for the mollusk and another invertebrate species, to be conducted with TGAI and TEP, are required. The TEP study must examine toxicity to the 

most sensitive species tested with the TGAI.

A passerine species is the required test organism for this study. A protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be 

submitted to the Agency within 90 days of receipt of this DCI.

A bench scale study of wastewater treatment is required to assess the percentage of esfenvalerate removed in the biosolids by the publicly owned treatment works (POTW) treatment, the 

amount that would degrade, and the amount that would remain in the wastewater. These data will be used to inform removal percentages by wastewater treatment, which is an input to the 

Exposure and Fate Assessment Screening Tool (E-FAST) used by the Agency to assess "down-the-drain" exposure.

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 IC50 

(concentration at which there is a 50% 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 esfenvalerate "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 

Case # and Name:

DCI Number:

Page: 2 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Esfenvalerate

GDCI-109303-828

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

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

species.

Case # and Name:

DCI Number:

Page: 3 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Esfenvalerate

Page: 1 of 1

10308

352

71532

SUMITOMO CHEMICAL COMPANY, LTD.

E. I. DU PONT DE NEMOURS AND COMPANY

(S300/419)

LG LIFE SCIENCES, LTD.

Co. Nr. Company Name Agent For Company

ICR, INC.

AG-CHEM CONSULTING

1330 DILLON HEIGHTS AVENUE

1007 MARKET STREET

12208 QUINQUE LANE

Address City ZIP

BALTIMORE

WILMINGTON

CLIFTON

212281199

198980001

20124 

OMB Approval 2070-0174

State

MD

DE

VA

 DCI Number: GDCI-109303-828
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