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 - Metalaxyl-M

Chemical # and Name: 113502

D-Alanine, N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-, methyl ester

17-Jun-2011

GENERIC

ID # GDCI-113502-940

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 _________________________________________________________________

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

850.1010

850.1025

850.1035

850.1075

Terrestrial Plant Toxicity (Seedling Emergence)

Terrestrial plant toxicity, Tier 1 (vegetative vigor)

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Aquatic invertebrate acute toxicity, test, freshwater 

daphnids

Oyster acute toxicity test (shell deposition)

Mysid acute toxicity test

Fish acute toxicity test, freshwater and marine

N/A - Metalaxyl-M

Chemical # and Name: 113502

D-Alanine, N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-, methyl ester

17-Jun-2011

GENERIC

ID # GDCI-113502-940

C,Q,A,B

C,Q,A,B

C,Q,A,B

C,Q,A,B

C,Q,A,B

C,Q,A,B

C,Q,A,B

TEP

TEP

EP; PAI; TGAI

TGAI, TEP

TGAI, TEP

TGAI, TEP

TGAI, TEP

12

12

12

24

12

12

18

Page 1 of 

(2, 5, 8, 23)

(1, 5, 7, 23)

(6, 18, 22)

(20)

(13, 14)

(12)

(10, 11, 15, 

16)

N

N

N

N

N

N

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

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.1350

850.2100

870.6200

870.7800

Mysid chronic toxicity test

Avian acute oral toxicity test

Neurotoxicity screening battery

Immunotoxicity

N/A - Metalaxyl-M

Chemical # and Name: 113502

D-Alanine, N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-, methyl ester

17-Jun-2011

GENERIC

ID # GDCI-113502-940

C,Q,A,B

C,Q,A,B

C,Q,A,B

C,Q,A,B

TGAI

EP; PAI; TGAI

TGAI

TGAI

12

12

24

12

Page 2 of 

(19)

(3, 17)

(21)

(4, 9)

N

Y

N

Y

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Metalaxyl-M

GDCI-113502-940

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

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

Refer to public draft guideline 850.4250 for guidance on Tier II vegetative vigor testing.

Refer to public draft guideline 850.4225 for guidance on Tier II seedling emergence testing.

Protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 day receipt of this Data Call-In.

Protocol must be submitted to the Agency for review and approval prior to study inception. The draft protocol must be submitted to the Agency within 90 day of receipt of this Data Call-In.

Data are required for six species of dicots from at least four families, one species of which is soybean (Glycine max). Data are required for four species of monocots from at least two families,

one species which is corn (Zea mays). At least one of either the monocot or dicot species must be a root crop.

Data are required for a freshwater green alga species, a freshwater diatom species, a marine diatom species, and a cyanobacterium (formerly known as blue-green algae).

Acceptable terrestrial plant toxicity data (vegetative vigor) for mefenoxam TEP are required.

Acceptable terrestrial plant toxicity data (seedling emergence) for mefenoxam TEP are required.

Acceptable immunotoxicity data for mefenoxam TGAI are required.

Acceptable freshwater fish acute toxicity data for the rainbow trout and bluegill species for mefenoxam TEP are required.

Acceptable freshwater fish acute toxicity data for the fathead minnow species for either metalaxyl TGAI or mefenoxam TGAI are required.

Acceptable estuarine and marine organism acute toxicity data for the mysid species for mefenoxam TEP are required.

Acceptable estuarine and marine organism acute toxicity data for the bivalve - oyster species for mefenoxam TEP are required.

Acceptable estuarine and marine organism acute toxicity data for the bivalve - oyster species for either metalaxyl TGAI or mefenoxam TGAI are required.

Acceptable estuarine and marine organism acute toxicity data for saltwater fish species for mefenoxam TEP are required.

Acceptable estuarine and marine organism acute toxicity data for saltwater fish species for either metalaxyl TGAI or mefenoxam TGAI are required.

Acceptable avian acute oral toxicity data for the passerine species for either metalaxyl TGAI or mefenoxam TGAI are required.

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

Q - Residential outdoor use

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Metalaxyl-M

GDCI-113502-940

18

19

20

21

22

23

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

Acceptable aquatic plant toxicity data for either metalaxyl TGAI or mefenoxam TGAI are required.

Acceptable aquatic invertebrate life cycle data for saltwater mysid species for either metalaxyl TGAI or mefenoxam TGAI are required.

Acceptable aquatic invertebrate acute toxicity data for the waterflea (Daphnia magna) species for mefenoxam TEP are required.

Acceptable acute and 90-day neurotoxicity screening battery data for the rat species for mefenoxam TGAI are required.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC50 

(concentration at which there is a 50% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that metalaxyl "may affect" and is "likely to adversely affect" listed plant 

species.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC25 

(concentration at which there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that metalaxyl "may affect" and is "likely to adversely affect" listed plant 

species.

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 - Metalaxyl-M

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-113502-940
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