UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460

 OFFICE OF CHEMICAL

 SAFETY AND 

 POLLUTION PREVENTION

March 15, 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 Metsulfuron.

The Registration Review public docket for Metsulfuron is located online at hppt://www.regulations.gov/ under 

docket number EPA-HQ-OPP-2011-0375.

INQUIRIES AND RESPONSES TO THIS NOTICE

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

established by this Notice, please contact Katherine St. Clair at 

stclair.katherine@epa.gov or (703) 347-8778.

.

All responses to this Notice for the GDCI data requirements are to be submitted to:

Katherine St. Clair, Chemical Review Manager

Risk Management and Implementation Branch RMIB 2,

Pesticide Re-evaluation Division (7508P)

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Ave. N. W.

Washington, D.C. 20460

By express or courier service:

Document Processing Desk (DCI/PRD)

Katherine St. Clair,

Office of Pesticide Programs (7508P)

One Potomac Yard (South Building),

2777 South Crystal Drive

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 - Metsulfuron

Chemical # and Name: 122010

Metsulfuron

15-Mar-2013

GENERIC

ID # GDCI-122010-1306

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)

835.1230

835.2240

835.2410

835.4100

835.4200

835.4300

835.4400

835.6100

835.6200

Sediment and soil absorption/desorption for parent 

and degradates

Direct photolysis rate of parent and degradates in 

water

Photodegradation of parent and degradates in soil

Aerobic soil metabolism

Anaerobic soil metabolism

Aerobic aquatic metabolism

Anaerobic aquatic metabolism

Terrestrial field dissipation

Aquatic field dissipation

N/A - Metsulfuron

Chemical # and Name: 122010

Metsulfuron

15-Mar-2013

GENERIC

ID # GDCI-122010-1306

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

PAIRA; TGAI

PAIRA; TGAI

PAIRA; TGAI

PAIRA; TGAI

PAIRA; TGAI

PAIRA; TGAI

PAIRA; TGAI

TGAI

TEP

12

12

12

24

24

24

24

24

24

Page 1 of 

(12)

(13)

(13)

(6)

(13)

(2)

(2)

(7, 10)

(11, 17)

N

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

 

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

Toxicology Data Requirements (Conventional Chemical)

850.4225

850.4250

850.4400

850.5400

850.2100

870.7800

Seedling emergence, Tier II

Vegetative vigor, Tier II

Aquatic plant toxicity test using Lemna spp. Tiers I 

and II

Algal toxicity, Tiers 1 and II

Avian acute oral toxicity test

Immunotoxicity

N/A - Metsulfuron

Chemical # and Name: 122010

Metsulfuron

15-Mar-2013

GENERIC

ID # GDCI-122010-1306

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

P,J,C,B,A

TEP

TEP

TEP; TGAI

DEGR

TGAI

TGAI

12

12

12

12

12

12

Page 2 of 

(9, 15)

(1, 15)

(3)

(4)

(5, 14)

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

 

SS-1144 Special Study for Non-Target Plant Reproductive 

Toxicity

N/A - Metsulfuron

Chemical # and Name: 122010

Metsulfuron

15-Mar-2013

GENERIC

ID # GDCI-122010-1306

P,J,C,B,A TEP 24

Page 3 of 

(8, 16) Y

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Metsulfuron

GDCI-122010-1306

1

2

3

4

5

6

7

8

9

10

11

12

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

Testing to be based on draft Guideline No. 850.4150.

Testing required in at least two different sediment:water systems that are similar to the potential use sites in the United States.

Testing is required for the degradate IN-A4098 (2-amino-4-methoxy-6-methyl 1, 3, 5-triazine).

Testing in green algae required. Testing is required for both the parent and the degradate IN-A4098 (2-amino-4-methoxy-6-methyl 1, 3, 5-triazine).

Testing in a passerine species required.

Requires testing in at least four relevant soils of different organic carbon content, pH, clay content, and microbial biomass.

Requirement is for environmental chemistry methods and independent laboratory validation only.

Protocol must propose test material, test species, study conditions, endpoints to be measured, etc. Protocol is due to Agency within six months of DCI issuance.

In addition to the Tier II seedling emergence testing that is required for the parent, Tier II seedling emergence testing is also required for the degradate IN-A4098 (2-amino-4-methoxy-6-methyl 1, 

3, 5-triazine).

Environmental chemistry methods used to generate data associated with this study must include results of successful confirmatory method trials by an independent laboratory. The 

environmental chemistry methods must include a statement of no data confidentiality claims, i.e., non-CBI. Test standards and procedures for independent laboratory validation are available as 

addenda to the guideline for this test requirement.

Environmental chemistry methods used to generate data associated with this study must include results of successful confirmatory method trials by an independent laboratory. The 

environmental chemistry methods must include a statement of no data confidentiality claims, i.e., non-CBI. Test standards and procedures for independent laboratory validation are available as 

addenda to the guideline for this test requirement.

Data for this data requirement are in review. If the Agency determines that the data in review are adequate to fulfill the data requirement, they will be used in the upcoming registration review 

risk assessment. If the Agency determines that the data currently in review are not adequate for purposes of the risk assessment, this data requirement will be outstanding. In addition, the 

inclusion of this data requirement in this registration review DCI provides a basis for a data compensation claim if and when future registrants cite this study to support new uses of metsulfuron 

methyl or a new product containing metsulfuron methyl. Registrants who intend to rely on the previously submitted data in responding to this DCI requirement may choose Response Option No.6,

that is, citing a study not yet reviewed by the Agency.

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

J - Forestry use

P - Aquatic nonfood crop

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Metsulfuron

GDCI-122010-1306

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

Data for this data requirement are in review. If the Agency determines that the data in review are adequate to fulfill the data requirement, they will be used in the upcoming registration review 

risk assessment. If the Agency determines that the data currently in review are not adequate for purposes of the risk assessment, this data requirement will be outstanding. In addition, the 

inclusion of this data requirement in this registration review DCI provides a basis for a data compensation claim if and when future registrants cite this study to support new uses of metsulfuron 

methyl or a new product containing metsulfuron methyl. Registrants who intend to rely on the previously submitted data in responding to this DCI requirement may choose Response Option 

No.6, that is, citing a study not yet reviewed by the Agency.

Data for mallard duck are currently in review. If the Agency determines that the data in review are adequate to fulfill the data requirement for testing in the mallard duck, they will be used in the 

upcoming registration review risk assessment. If the Agency determines that the data currently in review are not adequate for purposes of the risk assessment, this data requirement will be 

outstanding. In addition, the inclusion of this data requirement in this registration review DCI provides a basis for a data compensation claim if and when future registrants cite this study to 

support new uses of metsulfuron methyl or a new product containing metsulfuron methyl. Registrants who intend to rely on the previously submitted mallard duck data in responding to this DCI 

requirement may choose Response Option No.6, that is, citing a study not yet reviewed by the Agency.

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.

Based in part on a review of previously submitted data for another sulfonyl urea herbicide, the Agency has determined that generation of new non-guideline plant reproduction studies for each 

sulfonyl urea herbicide is unnecessary. The previously submitted data provide sufficient information for EPA to evaluate potential impacts of the sulfonyl urea herbicides on plant reproduction. 

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.

An acceptable aquatic field dissipation study is required. The full study, along with environmental chemistry methods and independent laboroatory validation, is required.

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 - Metsulfuron

Page: 1 of 1

352

81598

83558

35935

53883

228

83851

66330

4787

E. I. DU PONT DE NEMOURS AND COMPANY

(S300/419)

ROTAM LIMITED

CELSIUS PROPERTY B.V., AMSTERDAM 

(NL) 

NUFARM LIMITED

CONTROL SOLUTIONS, INC.

NUFARM AMERICAS, INC.

AMTIDE, LLC

ARYSTA LIFESCIENCE NORTH AMERICA, 

LLC 

CHEMINOVA A/S

Co. Nr. Company Name Agent For Company

IPM RESOURCES LLC

MAKHTESHIM AGAN OF NORTH 

AMERICA, INC.

NUFARM LIMITED

CHEMINOVA INC.

1007 MARKET STREET

P.O. Box 649

3120 HIGHWOODS BLVD., SUITE 100

4020 AERIAL CENTER PKWY., STE 101

5903 GENOA-RED BLUFF ROAD

4020 AERIAL CENTER PKWY., STE. 103

21 HUBBLE

15401 WESTON PARKWAY, SUITE 150

1600 WILSON BLVD., SUITE 700

Address City ZIP

WILMINGTON

HOCKESSIN

RALEIGH

MORRISVILLE

PASADENA

MORRISVILLE

IRVINE

CARY

ARLINGTON

198980001

19707 

27604 

27560 

775071041

27560 

92618 

27513 

22209 

OMB Approval 2070-0174

State

DE

DE

NC

NC

TX

NC

CA

NC

VA

 DCI Number: GDCI-122010-1306
ATTACHMENT 5 –

LINKS TO 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

ATTENTION DCI RESPONDENTS (see next page)
ATTENTION DCI RESPONDENTS

 

 

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.

Specifically the ICR associated with the DCI request is located at: 

http://www.reginfo.gov/public/servlet/ForwardServlet?SearchTarget=PRA&textfield=2070-0174