## 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 Pro tection 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 r equirements 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 pr oducts 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 In secticide, 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 Metsulf uron is located online at hppt://www.regulations.gov/ under docket number EPA

- HQ

- OPP

- 2011

- 0 375
. INQUIRIES AND RESPONSES TO THIS NOTICE If you have any questions regarding the generic data requirements and procedures established by this Notice, please con tact Katherine St. Clair at stclair.katherine@epa.gov or (703) 3 47

- 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 Implementat ion 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 22202INSTRUCTIONS: 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 1 Page of 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 Number13. 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



### 2 3 1 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 1 of Page

(12) (13) (13) (6) (13) (2) (2) (7, 10) (11, 17) N

N N N N N N N N 3OMB 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



### 2 3 1 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 2 of Page

(9, 15) (1, 15) (3) (4)

(5, 14) N

N N N

N

N 3OMB 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



### 2 3 1 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 3 of Page

(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: 1 Page: 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: 2 Page: of 2

### United States Environmental Protection Agency Washington, D.C. 20460 LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE N/A - Metsulfuron Case # and Name: 1 Page: 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 C onfidential Statement of Formula and Instructions (Form # 8570 - 4 ) 

# http://www.epa.gov/opprd001/forms/8570 - 4.pdf C ertification 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
C e rtification 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 informatio n 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” head ing, 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 ” b utton 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=207 0

- 0174