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 1 Page of 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 NumberInitial 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



### 2 3 1 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 1 of Page

(9, 17, 30) (8, 17, 30) (19, 29) (18, 29) N

N

N N N N 4OMB 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



### 2 3 1 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 2 of Page

(25) (26) (13, 15) (24) (14) (23, 27) (6, 22)
(1) N N N N N Y N

N 4OMB 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



### 2 3 1 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 3 of Page

(16) (11)
(5, 12) (7) (7) (7) (20) (11, 28) N

Y

N N N N N Y 4Date 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



### 2 3 1 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 4 of Page

(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: 1 Page: 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: 2 Page: 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: 3 Page: of 3

### United States Environmental Protection Agency Washington, D.C. 20460 LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE N/A - Esfenvalerate Case # and Name: 1 Page: 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 C onfidential Statement of Formula and Instructions (Form # 8570 -4 

# ) http://www.epa.gov/opprd001/forms/8570 - 4.pdf C ertification 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
C ertification With Respect to Citation of Data (Form # 8570 - 34 

# ) http://www.epa.gov/opprd001/forms/8570 - 34.pdf