### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### March 1, 2013 GENERIC DATA CALL
- IN NOTICE
Dear Sir or Madam: This Notice requires you and other registrants of pesticide products containing the active ingredient(s) identified in Attachment 1 of this Notice, the Data Call

- In Chemical Status Sheet , to submit certain data as noted herein to the U.S. Environmental Pro tection Agency (EPA, the Agency). These data are necessary for the Registration Review of your pesticide product(s) in its Registration Review case and to maintain the continued registration of your product(s) containing the active ingredient(s). Within 90 days after you receive this Notice, you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the r equirements set forth in this Notice and its Attachments 1 through 5; or,
2. Why you believe you are exempt from the requirements listed in this Notice and in Attachment 3, Generic Requirements Status and Registrant's Response Forms and Instructions Form, (see section III

- B); or,
3. Why you believe EPA should not require your submission of data in the manner specified by this Notice (see section III

- D). If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its requirements or should be exempt or excused from doing so, then the registration of your product(s) subject to this Notice will be subject to suspension. We have provided a list of all of your pr oducts subject to this Notice in Attachment 2, Generic Data Call

- In Response Forms Plus Instructions Form, as well as a list of all registrants who were sent this Notice (Attachment 4). The authority for this Notice is section 3(c)(2)(B) of the Federal In secticide, Fungicide and Rodenticide Act (FIFRA), as amended 7 U.S.C. section 136a(c)(2)(B ), sections 3(g)(2)(A) and (B) of FIFRA, as amended 7 U.S.C. sections 136 (a)(g)(2)(A) and (B), and section 408(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U.S.C. section 346a(f)(1)(A). This notice is also authorized by 40 CFR Part 155.48 and 40 CFR 155.53(b), which are sections in the Agency’s Registration Review regulations addressing the use of DataGENERIC DATA CALL
- IN CHEMICAL STATUS SHEET

INTRODUCTION We are sending you this Generic Data Call

- In (GDCI) Chemical Status Sheet because you have product(s) containing Dinotefuran

. The Registration Review public docket for Dinotefuran is located online at hppt://www.regulations.gov/ under docket number EPA

- HQ

- OPP

- 2011

- 0 920

. INQUIRIES AND RESPONSES TO THIS NOTICE If you have any questions regarding the generic data requirements and procedures established by this Notice, plea se contact Steven Snyderman at Snyderman.steve n @epa.gov

. or (703) 3 47

- 0249

. By US mail: By express or courier service: Document Processing D esk (DCI/PRD) Document Processing Desk (DCI/PRD) Steven Snyderman Steven Snyderman 

### US EPA (7508P) Office of Pesticide Programs (7508P) 1200 Pennsylvania Ave., NW 277 7 South Crystal Drive Washington, DC 20460 Arlington, V A 22202INSTRUCTIONS: 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 - Dinotefuran Chemical # and Name: 044312 Dinotefuran 01-Mar-2013 GENERIC ID # GDCI-044312-1147 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 Number13. 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)

Terrestrial and Aquatic Nontarget Organisms Data Requirements (Conventional Chemical) 835.4400

850.1350
850.2100
850.3040

SS-1155 SS-1156 SS-1157 Anaerobic aquatic metabolism

Mysid chronic toxicity test Avian acute oral toxicity test Field testing for pollinators

Residues in Pollen and Nectar/Field Residue Analysis Pollinator Larval Toxicity Study Laboratory Pollinator Chronic Feeding Study N/A - Dinotefuran Chemical # and Name: 044312 Dinotefuran 01-Mar-2013 GENERIC ID # GDCI-044312-1147

S,J,A,D,O,K,C,T,B,Q

S,J,A,D,O,K,C,T,B,Q S,J,A,D,O,K,C,T,B,Q S,J,A,D,O,K,C,T,B,Q

S,J,A,D,O,K,C,T,B,Q S,J,A,D,O,K,C,T,B,Q S,J,A,D,O,K,C,T,B,Q TGAI

TGAI TGAI
TEP

TGAI TGAI TGAI 24

12
12
24

36
12
12 1 of Page

(4)

(4, 6) (5, 7) (1)

(3) (1, 2) (1) N

N
Y
Y

Y
Y
Y 1United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS N/A - Dinotefuran GDCI-044312-1147

1

2 3 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 Office of Pesticide Programs has recently developed and is implementing its risk assessment for bees. Interim guidance regarding ecological testing for invertebrates with the honey bee has been made available, and can be found at: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-0004. The Agency's risk assessment process for bees can be found in its white paper submitted to the FIFRA Scientific Advisory Panel, September 11-14, 2012. This document can be found at: http://www.epa.gov/oppfead1/cb/csb_page/updates/2012/sapmtg-sept.html. This study with the honey bee is being required consistent with the pesticide risk assessment for bees, and specifically in relation to Tier 2 and/or Tier 3 data needs. The registrant should consult both the white paper, the interim guidance and work with the Agency to determine the design of the field study. A protocol must be submitted to the Agency within 90 days of receipt of the DCI for review prior to study initiation. Protocol should be submitted and based on Aupinel et al., 2007 or subsequent OECD guideline (currently under development) Prior to initiating these studies the registrant must develop and submit to EPA a protocol for review. The draft proocol must be submitted to the Agency within 90 days of reciept of the draft DCI. Development of monitoring protocols should be mindful of the following important goals as the Agency advances this and similar compounds to regulatory decision: 1. Establish a set of empirical pollen and nectar residue data to allow for a refined pollinator risk assessment for the monitored crops under a variety of application scenarios, soil, and hydric 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 B - Terrestrial feed crop C - Terrestrial nonfood crop D - Aquatic food crop J - Forestry use
K - Residential
O - Residential Indoor use
Q - Residential outdoor use S - Food handling/storage establishments premises and equipment T - Commercial, institutional and industrial premises and equipment 2United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS N/A - Dinotefuran GDCI-044312-1147

4

5 6 7 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

regimes expected to be encountered. 2. Provide sufficient information to allow for extrapolation of available pollen and nectar residue data for this particular chemical along with data from other chemicals within the same class to inform a higher tier extrapolation of available residue data from one crop/chemical combination to enhance predictions of residues in other crop/pesticide combinations that have not directly been monitored. When developing monitoring protocols to address the above goals, the registrant is urged to show consideration of the following issues that will likely be important to the Agency's evaluation of the adequacy of the protocol to meet the aforementioned goals: a. Attractiveness of the monitored crop to pollinators b. Robust representation of soil factors important to uptake of the pesticide by plants c. Robust representation of soil hydric/meteorological/and transpiration conditions for the crop monitored d. Thorough representation of application methods rates and timing e. Robust monitored crop selection to allow for a confident extrapolation of residue finding across a given crop grouping f. Robust monitoring of residues over time to determine whether annual accumulation in soil occurs or is bioavailable for plant uptake and to establish trends for residues in perennial plant tissues. g. Consideration of the market proportion of a given use site Previously submitted data provide sufficient information to fulfill this guideline data requirment. Registrants may wish to consider citing these existing data in response to this DCI. If this option is chosen, the registrant must address data compensation obligations (see section III.C. of this notice) in the 90-day response to the DCI. Data are required for passerine species. Data are preferred on oppossum shrimp (America mysis) formerly (Mysidopsis bahia). A protocol must be submitted to the Agency prior to the initiation of the study. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI. Case # and Name: DCI Number: 2 Page: of 2United States Environmental Protection Agency Washington, D.C. 20460 LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE N/A - Dinotefuran Case # and Name: 1 Page: of 1

73049
86203 VALENT BIOSCIENCES CORPORATION

MITSUI CHEMICALS AGRO, INC. Co. Nr. Company Name Agent For Company

LANDIS INTERNATIONAL, INC. 870 TECHNOLOGY WAY
P.O. Box 5126 Address City ZIP

LIBERTYVILLE
VALDOSTA 600486316
316035126 OMB Approval 2070-0174

State

IL
GA DCI Number: GDCI-044312-1147

## ATTENTION DCI RESPONDENTS Under the P aperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB con trol number. The approval of an information collection can only be valid for up to three years, at which time the agency must obtain a renewal of that approval. The currently valid OMB control numbers for the EPA regulations that appear in 40 CFR, after initial display in the final rule, are listed in 40 CFR part 9 and are included on the response form or collection instrument. For forms, in addition to the required inclusion of the OMB control number for the Information Collection Request (ICR ) containing the form, EPA has traditionally included the ICR expiration date on the form. When forms remain substantively unchanged for many years, the printed inventory of the form may not be exhausted before the expiration date used on the form. If th e same form is approved as part of the renewal process, the agency may continue to use the remaining stocks of the paper form, even though that form contains an obsolete expiration date. Although all of the attached forms that you are asked to u tilize in responding to this DCI are currently approved by OMB, some contain obsolete expiration dates, or address and per resp onse burden information in the P RA Notice. EPA is currently in the process of updating the electronic files of these forms, whic h are available on the internet at http://ww w.epa.gov/opprd001/forms , at which time EPA will also update the contents of the PRA Notice included on each form or as part of the instructions for the form. The public reporting and record keeping bu rden for this collection is estimated to average about 1063 hours per response for OPP’s Registration Review DCIs and 596 hours for OPP’s Reregistration DCIs . This includes the time for review ing the instructions, read ing and discuss ing test requirements, discussing test and protocol with the Agency, planning activities, searching existing data sources, gathering and maintaining the data needed, creating information, compiling, processing, completi ng , and review ing the collection of information, completi ng written forms, recording, disclosing, and display ing information, and stor ing and filing or maint ining information. This information (under Docket ID No. EPA

- HQ

- OPP

- 2007

- 0923

- 00 04)

– from the Registration Review Program’s Table 1B and the Reregistration Program’s Table 1 of the Final Supporting Statement for an Information Collection Request (ICR) for the Pesticide Data Call

- In Program may be accessed via: http://www.regulations.gov , or by: http://www.regulations.gov/search/Regs/home.html#docketDetail? R=EPA

- HQ

- OPP

- 2007

- 0923 Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Director, Collection Strategies Division (Mail Code 2822T), U.S. Environ mental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence, but do not submit the form or report to this address. The actual information or form should be submitted in accordance wit h the instructions accompanying the information or form, specified in the corresponding regulation. The supporting statement for the Information Collection Request (ICR) covering this DCI request is entitled “Pesticides Data call

- In Program” (OM B No. 2070

- 0174; EPA No. 2288.01). OMB No. 2070

- 0174 expires on March 31 , 2013

. For more information about the Agency’s burden estimates, please go to the following RegInfo.gov website produced by the office of Management and Budget (OMB): htt p://www.reginfo.gov/public/do/PRAMain . From this site location , under the “Information Collection Review” heading, submit a search by the agency name, or , in the blue bar area at top right of the page , select “ ICR ” and in the search window nearby type the OMB control number (2070

- 0174) , then click on the “ Go ” b utton at the right of the search window.