eypUnited States Environmental Protection Agency, Washington, D.C. 20460

DATA CALL-IN RESPONSE

OMB Approval 2070-0174

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.

1. Company Name and Address 2. Case # and Name

223 Difenzoquat

 Active Ingredient # and name

 106401 difenzoquat

3. Date and Type of DCI and Number

GENERIC FFDCA DCI

Item 9, enter the appropriate numerical response for each guideline study that you intend to support: 1 = Developing Data, 2 = Submitting an Existing Study, 3 = Upgrading a Study, 4 = 

Citing an Existing Study. (For 860.1500 or 860.1520, concerning a specific commodity, you may enter 5 = Will not support).

4. Guideline

Requirement

Number

5. Study title Footnotes to 

Data

Requirements

6a. Protocol 6b. Progress Reports 7. Test 

Substance

8. Time 

Frame

(Months)

9. Recipient 

Response 1 2 3

860.1500 Crop Field Trial – Wheat and barley 

hay and wheat forage 

No TEP 24

870.6200 Neurotoxicity Battery No TGAI 12

870.7800 Immunotoxicity Yes TGAI 12

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.

Signature of Individual or Signature and Title of Company’s Authorized Representative _____________________________________________

11. Date

12. Name of Company or Individual Contact (Include e-mail address) 13. Phone Number

Failure to Submit the 90-Day Response:

If a submission of a response to U.S. EPA to comply with the Data Call-In requirements of the final order is not submitted within 90 days after publication of the 

final order in the Federal Register, EPA may revoke the appropriate tolerance or tolerances associated with the active ingredient named in Item 2. 

90-Day Response Instructions:

Item 1, enter your company or individual name and address.

Item 6a identifies any study protocol report timeframe, if required by the Agency.

Item 6b identifies study progress report timeframes, if required by the Agency.

Item 7 identifies the code associated with the substance that must be used for testing: 
PAI = pure active ingredient, TGAI = technical grade active ingredient, EUP = end-use product, MP = manufacturing-use product, MET = metabolites, TEP = 

typical end-use product, PAI/M = pure active ingredient and metabolites, TEP/MET = typical end-use product and metabolites, DEGR = degradates, IMP = 

impurities, PAIRA = pure active ingredient radiolabeled, PAIRA/M = pure active ingredient radiolabeled and metabolites, PAIRA/PM = pure active ingredient 

radiolabeled and plant metabolites, TGAI/TEP = technical grade active ingredient or typical end-use product, PAI/PAIRA = pure active ingredient or pure active 

ingredient radiolabeled, MP/TGAI = manufacturing-use product and technical grade active ingredient, TGAI/PAIRA = technical active ingredient or pure active 

ingredient radiolabeled, TGAI/PAI = technical grade active ingredient or pure active ingredient, TEP/PAI/M = typical end-use product or pure active ingredient 

and metabolites.

Item 8 identifies timeframes for EPA’s receipt of data. Timeframes begin on the date of publication in the Federal Register of the final order for the Data Call-In.

Item 9, enter the appropriate numerical response for each guideline study that you intend to support: 1 = Developing Data, 2 = Submitting an Existing Study (that 

has not been submitted previously to EPA by anyone), 3 = Upgrading a Study (classified by EPA as partially acceptable and upgradeable), 4 = Citing an Existing 

Study (that EPA has classified as acceptable or an existing study that has been submitted but not reviewed by the Agency). Note, for guidelines 860.1500 or 

860.1520, concerning a specific commodity, you may enter 5 = Will not support.

Item 10, sign the certification statement – it must be signed by an authorized representative of your company and the person signing must include his/her title.

Item 11, enter the date of signature.

Item 12, enter the name of the person EPA should contact with questions regarding your response (Include e-mail address).

Item 13, enter the telephone number of your company contact.

Failure to Comply with Response Commitment and/or Data Requirements:

Events that may be the basis for revocation of tolerances associated with the active ingredient named in Item 2 include, but are not limited to the following:

No person submits on the required schedule: (1) an acceptable proposed or final protocol when such is required to be submitted to the Agency for review, (2) an 

adequate progress report on a study as required by the final order, (3) acceptable data as required by the final order, (4) supportable certifications as to the 

conditions of submitted data, where required by the final order and where no other cited or submitted study meets the data requirements the study was intended to 

fulfill.

United States Environmental Protection Agency, Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

Case # and Name 0223 Difenzoquat, GENERIC FFDCA DCI

OMB Approval 2070-0174

Footnotes:

870.7800 Immunotoxicity

1. A protocol must be submitted for Agency review prior to study initiation.