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 Protection 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 requirements 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 products 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 Insecticide, 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 Data 



















GENERIC 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-2011-0920.

INQUIRIES AND RESPONSES TO THIS NOTICE

If you have any questions regarding the generic data requirements and procedures

established by this Notice, please contact Steven Snyderman at

Snyderman.steven@epa.gov. or (703) 347-0249.

By US mail: By express or courier service:

Document Processing Desk (DCI/PRD) Document Processing Desk (DCI/PRD) 

Steven Snyderman Steven Snyderman

US EPA (7508P) Office of Pesticide Programs (7508P)

1200 Pennsylvania Ave., NW 2777 South Crystal Drive

Washington, DC 20460 Arlington, VA 22202

 

 

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 - 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

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 




 

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)

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

Page 1 of 

(4)

(4, 6)

(5, 7)

(1)

(3)

(1, 2)

(1)

N

N

Y

Y

Y

Y

Y

1
United 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:

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

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

2
United 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:

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 - Dinotefuran

Page: 1 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 Paperwork 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 control 

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 the 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 utilize in responding to this DCI are currently approved 

by OMB, some contain obsolete expiration dates, or address and per response burden information in the PRA Notice. 

EPA is currently in the process of updating the electronic files of these forms, which are available on the internet at 

http://www.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 burden 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 reviewing the instructions, reading and discussing 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, completing, and reviewing the collection of information, completing written forms, recording, 

disclosing, and displaying information, and storing and filing or maintining information. This information (under 

Docket ID No. EPA-HQ-OPP-2007-0923-0004) – 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. 

Environmental 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 with 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” (OMB 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): http://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” button at the right of the search window.