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 - Gardona (cis-isomer)

Chemical # and Name: 083702

Gardona (cis-isomer)

29-Dec-2009

GENERIC

ID # GDCI-083702-1011

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

N/A

N/A

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 _________________________________________________________________

 

Environmental Fate Data Requirements (Conventional 

Chemical)

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

835.2120

835.4100

835.6100

835.6200

850.4100

850.4150

850.4400

850.5400

Hydrolysis of parent and degradates as a function of 

pH at 25 C

Aerobic soil metabolism

Terrestrial field dissipation

Aquatic field dissipation

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 - Gardona (cis-isomer)

Chemical # and Name: 083702

Gardona (cis-isomer)

29-Dec-2009

GENERIC

ID # GDCI-083702-1011

II,R

II,R

II,R

II,R

II,R

II,R

II,R

II,R

PAIRA; TGAI

PAIRA; TGAI

TEP

TEP

TEP

TEP

TEP; TGAI

TEP; TGAI

12

24

24

24

12

12

12

12

Page 1 of 

(7)

(6)

(8, 15)

(2)

(5)

(5)

(4)

(3)

N

N

N

N

N

N

N

N

3
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

 

Product Chemistry Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

830.7050

850.1300

850.1400

850.2300

870.3465

870.7800

UV/Visible absorption

Daphnid chronic toxicity test

Fish early-life stage toxicity test

Avian reproduction test

90-day inhalation toxicity

Immunotoxicity

N/A - Gardona (cis-isomer)

Chemical # and Name: 083702

Gardona (cis-isomer)

29-Dec-2009

GENERIC

ID # GDCI-083702-1011

II,R

II,R

II,R

II,R

II,R

II,R

MP; PAI; TGAI

TGAI

TGAI

TGAI

TGAI

TGAI

8

12

12

24

24

12

Page 2 of 

(9, 12)

(11)

(9, 10)

(14)

(1)

N

N

N

N

N

N

3
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

 

SS-1077 Manure Dissipation, Special Study

N/A - Gardona (cis-isomer)

Chemical # and Name: 083702

Gardona (cis-isomer)

29-Dec-2009

GENERIC

ID # GDCI-083702-1011

II,R EP; PAI; TGAI 24

Page 3 of 

(13) Y

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Gardona (cis-isomer)

GDCI-083702-1011

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

This study is now based on the Revised Part 158 Toxicology Data Requirements for Conventional Pesticides.

The requirement of environmental chemistry methods for water is listed in he CFR as a footnote to the aquatic field dissipation study. In this DCI independently validated analytical methods for 

residues in water are being required for residues of the tetrachlorvinphos Z-isomer in water. The aquatic field dissipation study is not required at this time.

The Agency is requesting a Tier 1 Algal toxicity study.

The Agency is requesting Tier 1 aquatic plant toxicity study.

Study should be conducted according to GLP guidelines.

GLP-compliant study that determines the degradation rate and characterizes all of the tetrachlorvinphos Z-isomer degradation products, including those with the phosphate moiety, on all four 

soils.

GLP-compliant study that characterizes the hydrolytic degradation of the tetrachlorvinphos Z-isomer and all degradates, including those with the phosphate moiety.

Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards 

and procedures for independent Laboratory Validation are available as addenda to the guideline for this test requirement.

Data using the TGAI are required to support all outdoor end-use product uses.

Data are required on waterfowl and upland game bird species.

Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96-hour LC50 on that species must 

also be provided.

Data are required on one freshwater aquatic invertebrate species.

Data are needed to characterize the behavior of the tetrachlorvinphos Z-isomer and all metabolites and degradates including those with the phosphate moiety once the feed-through product is 

excreted by livestock. A GLP compliant study of residues from multiple cows that charaterizes all of the degradates (including those with the phosphate moiety) and an approved study protocol

is required.

Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., or 28-days, are sufficient to satisfy this requirement.

An analytical method for the tetrachlorvinphos Z-isomer residues in soil and independent validation of the analytical method for the Z-isomer residues in soil are required. The terrestrial field 

dissipation study is not required at this time.

Case # and Name:

DCI Number:

Page: 1 of 1

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:

R - Agricultural premises and equipment

II - Residential Use Conventional Chemical
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Gardona (cis-isomer)

Page: 1 of 1

2596

61483

THE HARTZ MOUNTAIN CORPORATION

KMG-BERNUTH, INC

Co. Nr. Company Name Agent For Company

400 PLAZA DRIVE

9555 W. SAM HOUSTON PKWY SOUTH, SUITE 

600 

Address City ZIP

SECAUCUS

HOUSTON

07094 

77099 

OMB Approval 2070-0174

State

NJ

TX

 DCI Number: GDCI-083702-1011
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