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 - Azoxystrobin

Chemical # and Name: 128810

Azoxystrobin

09-Nov-2011

GENERIC

ID # GDCI-128810-892

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 _________________________________________________________________

Applicator Exposure Data Requirements (Conventional 

Chemical)

Environmental Fate Data Requirements (Conventional 

Chemical)

Post-Application Exposure Data Requirements (Conventional 

Chemical)

875.1300

875.1400

875.1600

835.4300

835.6200

875.2300

875.2800

Inhalation exposure--outdoor

Inhalation exposure--indoor

Application exposure monitoring data reporting

Aerobic aquatic metabolism

Aquatic field dissipation

Indoor surface residue dissipation

Description of human activity

N/A - Azoxystrobin

Chemical # and Name: 128810

Azoxystrobin

09-Nov-2011

GENERIC

ID # GDCI-128810-892

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

TEP

TEP

TEP

TGAI

TEP

TEP

TEP

24

24

12

24

24

24

24

Page 1 of 

(6, 15)

(5, 15)

(7, 9)

(13)

(4, 12)

(10, 15)

(2)

Y

Y

N

N

N

Y

N

2
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

Residue Chemistry Data Requirements for Food Uses 

(Conventional Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

860.1500

860.1500

850.2100

870.7800

875.2700

Crop field trials (BLACKBERRY) 

Crop field trials (CRANBERRY) 

Avian acute oral toxicity test

Immunotoxicity

Product Use Information

N/A - Azoxystrobin

Chemical # and Name: 128810

Azoxystrobin

09-Nov-2011

GENERIC

ID # GDCI-128810-892

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

U,GG,C,A,T,K

TEP

TEP

EP; PAI; TGAI

TGAI

TEP

24

24

24

12

12

Page 2 of 

(1)

(14)

(11, 16)

(3, 8)

N

N

N

N

N

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Azoxystrobin

GDCI-128810-892

1

2

3

4

5

6

7

8

9

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

Two additional field trials are required for the caneberry subgroup; one trial should be conducted in Region 1 or 2, and one trial should be conducted in Region 5 or 6. Blackberry or raspberry 

field trial studies would be acceptable.

The Agency is requiring more information on the end product user itself for the antimicrobial uses of azoxystrobin. The Agency needs to know how users are contacting the product and in 

what ways, including the frequency or duration of contact. This information would help the Agency ensure that the PPE requirements are adequate. If the registrant elects to be descriptive, 

then no protocol is needed. However, if the registrant conducts a study to depict the behavior/use patterns, then a protocol will be required and may potentially need to be reviewed by the 

Human Studies Review Board.

The Agency is requiring information regarding the end use/end use applications of the antimicrobial uses of azoxystrobin (i.e., paints, plastics, preservatives, adhesives, etc.). The Agency 

requires data/information regarding how the registered products are used, along with the actual types of consumer goods that are or can be manufactured with azoxystrobin. For instance, the 

Agency is interested in what kinds of plastics azoxystrobin is used in so that the Agency can determine the necessity and types of exposure, or with respect to paints, whether azoxystrobin is

used industrially, residentially, commercially, etc. This type of information will help the Agency avoid making generic assumptions.

Requirement is for water environmental chemistry analytical method only; the aquatic field dissipation study is not required. The submission must include results of a successful confirmatory 

method trial by an independent laboratory. The submission must include a statement of no data confidentiality. Test standards and procedures for independent laboratory validation are available

as addenda to the guideline for this requirement.

Inhalation exposure data are needed for both residential and occupational use scenarios for the antimicrobial uses of azoxystrobin. The study design for each scenario (indoor and outdoor) 

should consider the use pattern likley to result in the greatest exposure.

Inhalation exposure data are needed for both residential and occupational use scenarios for the antimicrobial uses of azoxystrobin. The study design for each scenario (indoor and outdoor) 

should consider the use pattern likely to result in the greatest exposure.

In accordance with 40 CFR 158.1020, OPPTS Guideline 875.1600 is required to accompany 875.1300 (Inhalation Outdoor Exposure) and 875.1400 (Inhalation Indoor Exposure). When both 

inhalation exposure GLNs are listed, the registrant is only required to perform one of the two inhalation exposure tests (that which is expected to result in the greatest exposure). A protocol 

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

If the registrant elects to be descriptive, then no protocol is needed. However, if the registrant conducts a study to depict the behavior/use patterns, then a protocol will be required and may 

potentially need to be reviewed by the Human Studies Review Board.

Guideline refers to reporting and report format.

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

C - Terrestrial nonfood crop

K - Residential

T - Commercial, institutional and industrial premises

and equipment

U - Residential and public access premises

GG - Low Exposure Antimicrobial

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Azoxystrobin

GDCI-128810-892

10

11

12

13

14

15

16

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

Due to plastic antimicrobial uses for azoxystrobin, the Agency assumes this can potentially be incorporated into children's toys (and therefore presenting potential exposure via the oral route). 

This study should provide chemical specific migration data to quantify the amount of azoxystrobin that may potentially leach out and become available. Please note that the registrant may elect 

to implement label language to restrict the manufacturing of toys, and if this is pursued, then this guideline study will no longer be required.

Data is needed on passerine species.

An environmental chemistry method for azoxystrobin residues in water was submitted by the registrant. However, an independent validation of this method was not submitted with the method. 

Therefore, an independent laboratory validation of the submitted analytical method for azoxystrobin residues in water is required to support monitoring for azoxystrobin residues and to evaluate 

submitted environmental fate and ecological effects data. The method submitted also did not include the Z-isomer of azoxystrobin. Therefore, an environmental chemistry method for 

azoxystrobin, and residues of concern, in water with independent laboratory validation of the method, are required.

An aerobic aquatic metabolism study is required for both azoxystrobin and its degradate, z-isomer (compound 9).

An additional cranberry field trial study using the WDG formulation is required in either Region 1 or 5.

A study protocol should be submitted for Agency approval, prior to study initiation.

A protocol is recommended to be submitted to the Agency for comment before study initiation. Before developing the protocol, it is also recommended that a range-finding test is conducted first 

to establish the concentrations that will be used in the test. If the concentrations cannot be established due to regurgitation, the registrant will need to show how they will test up to the 

maximum concentration required for an avian acute oral toxicity test with passerines.

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 - Azoxystrobin

Page: 1 of 1

100 SYNGENTA CROP PROTECTION, LLC

Co. Nr. Company Name Agent For Company

410 SWING ROAD, P.O. Box 18300

Address City ZIP

GREENSBORO 274198300

OMB Approval 2070-0174

State

NC

 DCI Number: GDCI-128810-892
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